- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05770037
DETERMINE Trial Treatment Arm 01: Alectinib in Adult, Teenage/Young Adults (TYA) and Paediatric Patients With ALK Positive Cancers (DETERMINE)
DETERMINE (Determining Extended Therapeutic Indications for Existing Drugs in Rare Molecularly Defined Indications Using a National Evaluation Platform Trial): An Umbrella-Basket Platform Trial to Evaluate the Efficacy of Targeted Therapies in Rare Adult, Paediatric and Teenage/Young Adult (TYA) Cancers With Actionable Genomic Alterations, Including Common Cancers With Rare Actionable Alterations. Treatment Arm 01: Alectinib in Adult, Teenage/Young Adults (TYA) and Paediatric Patients With ALK Positive Cancers
This clinical trial is looking at a drug called alectinib. Alectinib is approved as standard of care treatment for adult patients with certain types of lung cancer. This means it has gone through clinical trials and been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. Alectinib works in lung cancer patients with a particular mutation in their cancer known as ALK.
Investigators now wish to find out if it will be useful in treating patients with other cancer types which have the same mutation. If the results are positive, the study team will work with the NHS and the Cancer Drugs Fund to see if these drugs can be routinely accessed for patients in the future.
This trial is part of a trial programme called DETERMINE. The programme will also look at other anti-cancer drugs in the same way, through matching the drug to rare cancer types or ones with specific mutations.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
DETERMINE Treatment Arm 01 (alectinib) aims to evaluate the efficacy of alectinib in ALK-positive rare* adult, paediatric and teenage/young adult (TYA) cancers and in common cancers where an ALK mutation or amplification is considered to be infrequent.
*Rare is defined generally as incidence less than 6 cases in 100,000 patients (includes paediatric and teenagers/young adult cancers) or common cancers with rare alterations.
This treatment arm has a target sample size of 30 evaluable patients. Sub-cohorts may be defined and further expanded where promising activity is identified to a target of 30 evaluable patients each.
The ultimate aim is to translate positive clinical findings to the NHS (Cancer Drugs Fund) to provide new treatment options for rare adult, paediatric and TYA cancers.
OUTLINE:
Pre-screening: The Molecular Tumour Board makes a treatment recommendation for the participant based on molecularly-defined cohorts (See information on Master Screening Protocol below).
Screening: Consenting participants undergo biopsy and collection of blood samples for research purposes.
Treatment: Participants will receive alectinib until disease progression, unacceptable toxicity or withdrawal of consent. Participants will also undergo collection of blood samples at various intervals while receiving treatment and at EoT.
After completion of study treatment, patients are followed up every 3 months for 2 years.
THE DETERMINE TRIAL MASTER (SCREENING) PROTOCOL:
Please see DETERMINE Trial Master (Screening) Protocol record (NCT05722886) for information on the DETERMINE Trial Master Protocol and applicable documents.
Study Type
Enrollment (Estimated)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Contact
- Name: Aida Sarmiento Castro
- Phone Number: +442034695101
- Email: determine@cancer.org.uk
Study Locations
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Belfast, United Kingdom, BT9 7AB
- Recruiting
- Belfast City Hospital
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Contact:
- Vicky Coyle, Prof
- Email: V.Coyle@qub.ac.uk
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Principal Investigator:
- Vicky Coyle, Prof
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Birmingham, United Kingdom
- Not yet recruiting
- Birmingham Children's Hospital
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Contact:
- Susanne Gatz, Dr
- Phone Number: 0121 333 9999
- Email: Susanne.Gatz@nhs.net
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Principal Investigator:
- Susanne Gatz, Dr
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Birmingham, United Kingdom, B15 2TT
- Recruiting
- University Hospital Birmingham
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Contact:
- Gary Middleton, Prof
- Phone Number: 0121 371 3573
- Email: G.Middleton@bham.ac.uk
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Principal Investigator:
- Gary Middleton, Prof
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Bristol, United Kingdom, BS2 8ED
- Not yet recruiting
- Bristol Haematology and Oncology centre
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Contact:
- Antony Ng, Dr
- Phone Number: 0117 342 8044
- Email: Antony.Ng@uhbw.nhs.uk
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Principal Investigator:
- Antony Ng, Dr
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Bristol, United Kingdom, BS2 8BJ
- Not yet recruiting
- Bristol Royal Hospital for Children
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Contact:
- Antony Ng, Dr
- Phone Number: 0117 342 8044
- Email: Antony.Ng@uhbw.nhs.uk
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Principal Investigator:
- Antony Ng, Dr
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Cambridge, United Kingdom, CB2 OQQ
- Recruiting
- Addenbrooke's Hospital
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Contact:
- Bristi Basu, Dr
- Phone Number: 01223 596105
- Email: bb313@medschl.cam.ac.uk
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Principal Investigator:
- Bristi Basu, Dr
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Cardiff, United Kingdom, CF14 2TL
- Not yet recruiting
- Velindre Cancer Centre
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Contact:
- Robert Jones, Dr
- Phone Number: 6327 02920 615888
- Email: Robert.Hugh.Jones@wales.nhs.uk
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Principal Investigator:
- Robert Jones, Dr
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Edinburgh, United Kingdom, EH4 2XU
- Recruiting
- Western General Hospital
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Contact:
- Stefan Symeonides, Dr
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Principal Investigator:
- Stefan Symeonides, Dr
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Glasgow, United Kingdom, G51 4TF
- Not yet recruiting
- Royal Hospital for Children Glasgow
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Contact:
- Milind Ronghe, Dr
- Phone Number: 0141 452 6692
- Email: Milind.Ronghe@ggc.scot.nhs.uk
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Principal Investigator:
- Milind Ronghe, Dr
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Glasgow, United Kingdom, G12 OYN
- Recruiting
- The Beatson Hospital
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Contact:
- Patricia Roxburgh, Dr
- Phone Number: 0141 301 7118
- Email: Patricia.Roxburgh@glasgow.ac.uk
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Principal Investigator:
- Patricia Roxburgh, Dr
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Leeds, United Kingdom, LS1 3EX
- Not yet recruiting
- Leeds General Infirmary
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Contact:
- Martin Elliott, Dr
- Phone Number: 0113 392 8779
- Email: martin.elliott1@nhs.net
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Principal Investigator:
- Martin Elliott, Dr
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Leicester, United Kingdom, LE1 5WW
- Recruiting
- Leicester Royal Infirmary
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Contact:
- Anne Thomas, Dr
- Phone Number: 0116 2587601
- Email: at107@le.ac.uk
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Principal Investigator:
- Anne Thomas, Dr
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Liverpool, United Kingdom, L14 5AB
- Not yet recruiting
- Alder Hey Hospital
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Contact:
- Lisa Howell, Dr
- Phone Number: 0151 293 3679
- Email: Lisa.Howell@alderhey.nhs.uk
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Principal Investigator:
- Lisa Howell, Dr
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London, United Kingdom, WC1N 3JH
- Not yet recruiting
- Great Ormond Street Hospital
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Contact:
- Darren Hargrave, Dr
- Phone Number: 0207 813 8525
- Email: Darren.hargrave@gosh.nhs.uk
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Principal Investigator:
- Darren Hargrave, Dr
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London, United Kingdom, NW1 2BU
- Recruiting
- University College London Hospital
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Contact:
- Martin Foster, Prof
- Phone Number: 020 3447 5085
- Email: M.Forster@ucl.ac.uk
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Principal Investigator:
- Martin Foster, Prof
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London, United Kingdom, SE1 9RT
- Recruiting
- Guy's Hospital
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Contact:
- James Spicer, Dr
- Phone Number: 020 7188 4260
- Email: james.spicer@kcl.ac.uk
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Principal Investigator:
- James Spicer, Dr
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London Borough of Sutton, United Kingdom, SM2 5PT
- Not yet recruiting
- The Royal Marsden Hospital
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Contact:
- Lynley Marshall, Dr
- Phone Number: 0208 661 3678
- Email: LynleyVanessa.Marshall@icr.ac.uk
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Principal Investigator:
- Lynley Marshall, Dr
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Manchester, United Kingdom, M13 9WL
- Not yet recruiting
- Royal Manchester Children's Hospital
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Contact:
- Guy Makin, Dr
- Phone Number: 0161 701 8419
- Email: Guy.Makin@mft.nhs.uk
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Principal Investigator:
- Guy Makin, Dr
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Manchester, United Kingdom, M20 4BX
- Recruiting
- The Christie Hospital
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Principal Investigator:
- Matthew Krebs, Prof
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Contact:
- Matthew Krebs, Prof
- Phone Number: 0161 918 7672
- Email: Matthew.Krebs@nhs.net
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Newcastle, United Kingdom, NE7 7DN
- Recruiting
- Freeman Hospital
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Principal Investigator:
- Alastair Greystoke, Dr
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Contact:
- Alastair Greystoke, Dr
- Phone Number: 0191 2138476
- Email: Greystoke@newcastle.ac.uk
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Newcastle, United Kingdom, NE1 4LP
- Recruiting
- Great North Children's Hospital
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Contact:
- Alastair Greystoke, Dr
- Phone Number: 0191 2138476
- Email: Alastair.Greystoke@newcastle.ac.uk
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Principal Investigator:
- Alastair Greystoke, Dr
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Oxford, United Kingdom, OX3 7LE
- Recruiting
- Churchill Hospital
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Contact:
- Sarah Pratap, Dr
- Phone Number: 01865 235273
- Email: Sarah.Pratap@ouh.nhs.uk
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Principal Investigator:
- Sarah Pratap, Dr
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Oxford, United Kingdom, OX3 9DU
- Recruiting
- John Radcliffe Hospital
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Contact:
- Sarah Pratap, Dr
- Phone Number: 01865 235273
- Email: Sarah.Pratap@ouh.nhs.uk
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Principal Investigator:
- Sarah Pratap, Dr
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Sheffield, United Kingdom, S10 2SJ
- Not yet recruiting
- Weston Park Hospital
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Contact:
- Sarah Danson, Dr
- Phone Number: 0114 226 5068
- Email: s.danson@sheffield.ac.uk
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Principal Investigator:
- Sarah Danson, Dr
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Southampton, United Kingdom, SO16 6YD
- Not yet recruiting
- Southampton General Hospital
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Contact:
- Juliet Gray, Prof
- Phone Number: 0238 120 6639
- Email: Juliet.Gray@uhs.nhs.uk
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Principal Investigator:
- Juliet Gray, Prof
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Wirral, United Kingdom, CH63 4JY
- Not yet recruiting
- Clatterbridge Cancer Centre
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Contact:
- Dan Palmer, Dr
- Phone Number: 0151 706 4172 / 0151 706 4177
- Email: daniel.palmer@liverpool.ac.uk
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Principal Investigator:
- Dan Palmer, Dr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
THE PARTICIPANT MUST FULFIL THE ELIGIBILITY CRITERIA WITHIN THE DETERMINE MASTER PROTOCOL (NCT05722886) AND WITHIN THE TREATMENT ARM 01 (ALECTINIB) OUTLINED BELOW*
*When alectinib-specific inclusion/exclusion criteria or precautions below differ from those specified in the Master Protocol, the Alectinib-specific criteria will take precedence.
Inclusion Criteria:
A. Confirmed diagnosis of an ALK-positive malignancy using an analytically validated method.
B. Women of childbearing potential are eligible, provided that they meet the following criteria:
- Have a negative serum or urine pregnancy test before enrolment and;
- Agree to use one form of highly effective birth control method such as:
I. combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation [oral, intravaginal or transdermal])
II. progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable or implantable)
III. intrauterine device (IUD)
IV. intrauterine hormone-releasing system (IUS)
V. bilateral tubal occlusion
VI. vasectomised partner
VII. sexual abstinence
Effective from the first administration of alectinib, throughout the trial and for three months after the last administration of alectinib.
C. Male patients with partners who are women of childbearing potential are eligible provided that they agree to the following, from first administration of alectinib, throughout the trial and for three months after the last administration of alectinib:
- Agree to take measures not to father children by using a barrier method of contraception (condom plus spermicide) or sexual abstinence.
- Non-vasectomised male patients with partners who are women of childbearing potential must also be willing to ensure that their partner uses a highly effective method of contraception, as in criterion B, above.
- Male patients with pregnant or lactating partners must be advised to use barrier method contraception (for example, condom plus spermicide) to prevent drug exposure of the foetus or neonate.
D. Patients must be able and willing to undergo a fresh biopsy.
E. ADULT PATIENTS: Adequate organ function as per haematological and biochemical indices within the ranges shown below. These measurements should be performed to confirm the patient's eligibility.
Haemoglobin (Hb): ≥90 g/L (transfusion allowed)
Absolute neutrophil count (ANC): ≥1.5×10^9/L (no granulocyte colony-stimulating factor [GCSF] support in preceding 72 hours)
Platelet count:≥100×10^9/L (unsupported for 72 hours)
Bilirubin: <1.5 x upper limit of normal (ULN) or ≤2.5 x ULN if raised due to metastases
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST): ≤2.5 x ULN or ≤ 5 ULN if raised due to metastases
Coagulation - prothrombin (PT) (or international normalized ratio [INR]) and activated partial thromboplastin clotting time (aPTT) : ≤1.5 x lower limit of normal (LLN)/ULN (unless patient is on anticoagulants e.g. warfarin [INR should be stable and within indicated therapeutic range], or direct oral anticoagulants [DOAC])
Estimated glomerular filtration rate (eGFR): eGFR: ≥30 mL/min (uncorrected value)
F. PAEDIATRIC PATIENTS: Adequate organ function as per haematological and biochemical indices within the ranges shown below. These measurements should be performed to confirm the patient's eligibility
Haemoglobin: ≥80 g/L (transfusion allowed)
ANC: ≥1.0×10^9/L (no GCSF support in preceding 72 hours)
Platelet count: ≥75×10^9/L (unsupported for 72 hrs)
Bilirubin: ≤1.5 x ULN for age or <2.5 x ULN if raised due to metastases
ALT and AST: ≤3.0 x ULN or ≤ 5 ULN if raised due to metastases
Coagulation - PT or INR and aPTT: For patients not receiving therapeutic anticoagulation: INR and aPTT ≤1.5 x ULN for age. For patients receiving therapeutic anticoagulation: stable anticoagulant regimen, e.g. warfarin (INR should be stable and within indicated therapeutic range) or DOAC.
eGFR: eGFR: ≥60 mL/min/1.73m^2
Exclusion Criteria:
A. Diagnosis of ALK-positive non-small cell lung cancer.
B. Female patients who are pregnant, breastfeeding or planning to become pregnant during the trial or for three months following their last dose of alectinib.
C. Patients with rapidly progressing or symptomatically deteriorating brain metastases. Patients with previously treated brain metastases are eligible, provided the patient has not experienced a seizure or had a clinically significant change in neurological status within the 14 days prior to the start of alectinib administration. Such patients must be nondependent on steroids or on a stable or reducing dose of steroid treatment for at least 14 days (or one week for paediatric patients) prior to the start of alectinib administration. Primary brain or CNS malignancies are allowed providing the patient is clinically stable (if requiring corticosteroids must be at stable or decreasing doses for at least 14 days for adults and 7 days for paediatric patients prior to the start of alectinib administration). Patients who have received brain irradiation must have completed whole-brain radiotherapy and/or stereotactic radiosurgery at least 14 days prior to the start of alectinib administration.
D. Prior treatment with the same class of drug unless genetic profile demonstrates a mechanism of resistance known to be potentially sensitive to alectinib.
E. History of or radiological evidence of interstitial lung disease and/or pneumonitis. Prior localised radiotherapy related pneumonitis is permitted if resolved and off steroids and asymptomatic for >6 months.
F. Patients at risk of gastrointestinal (GI) perforation e.g. history of diverticulitis, concomitant use of medicinal product with a recognized risk of gastrointestinal perforation (unless patient has also been co-prescribed gastric protection). Patients who present with a GI primary tumour or metastases to the GI tract may be considered.
G. Patient unable to swallow or tolerate oral medication or any GI disorder that may affect absorption of oral medications, such as malabsorption syndrome or following major bowel resection. Paediatric patients will be excluded if they are unable to swallow the capsules, as per the dosing schedule (150 mg dose strength).
H. Patients with clinically significant pre-existing cardiac conditions, including uncontrolled or symptomatic angina, uncontrolled atrial or ventricular arrhythmias (within three months), or New York Heart Association (NYHA) class III or IV congestive heart failure. Patients with a cerebrovascular event (including stroke or transient ischaemic attack [TIA]), or cardiovascular event (including acute myocardial infarction [MI]), within three months before the first dose of alectinib.
I. History of organ transplantation.
J. Symptomatic bradycardia for age.
K. Known hypersensitivity to alectinib or any of the excipients.
L. Active hepatitis B or C virus or known human immunodeficiency virus (HIV) positivity or acquired immune deficiency syndrome related illness.
M. Familial or personal history of congenital bone disorders, bone metabolism alterations or known osteopenia in the patient.
N. Any clinically significant concomitant disease or condition (or it's treatment) that could interfere with, the conduct of the trial or absorption of oral medications that would, in the opinion of the Investigator, pose an unacceptable risk to the patient in this trial.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Treatment Arm 01: Alectinib
This alectinib treatment arm is for adult, teenage/young adult (TYA) and paediatric participants with ALK-positive cancers.
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Adult participants will be administered alectinib orally at a dose of 600 mg (four 150 mg capsules) twice daily. Paediatric participants with a body weight ≥40 kg and who are able to swallow the capsules, will be administered alectinib orally at a dose of 600 mg (four 150 mg capsules) twice daily. Each cycle of treatment will consist of 28 days and participants may continue on treatment until disease progression, unacceptable toxicity or withdrawal of consent.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Durable Clinical Benefit (DCB)
Time Frame: Disease assessments to be performed up to 24 weeks from the start of trial treatment.
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DCB is defined as the absence of disease progression for at least 24 weeks from the start of trial treatment according to RECIST Version 1.1 criteria (or ir-RECIST or standard imaging criteria for specific disease e.g.
RANO criteria).
Alternative definitions of DCB based on different time points may be pre-specified for particular sub-cohorts if 24 weeks is not clinically relevant.
The trial will report the proportion of patients with a DCB and 95% credible interval.
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Disease assessments to be performed up to 24 weeks from the start of trial treatment.
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Objective Response (OR)
Time Frame: Disease assessments to be performed up to 24 weeks from the start of trial treatment.
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An OR is defined as the confirmed occurrence of either a Complete Response (CR) or Partial Response (PR) according to Response Evaluation Criteria in Solid Tumours (RECIST) Version 1.1 criteria (or immune related (ir)-RECIST or standard imaging criteria for specific disease e.g.
Response Evaluation in Neuro Oncology criteria (RANO)).
In patients with leukaemia, OR will be defined as the occurrence of CR, CRi (CR incomplete neutrophil recovery) or CRp (CR with incomplete platelet recovery).
The trial will report the proportion of patients with an OR and 95% credible interval.
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Disease assessments to be performed up to 24 weeks from the start of trial treatment.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Survival time (OS)
Time Frame: Time of death or up to 2 years after the End of Treatment (EoT) visit.
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OS is defined as the time from date of starting trial treatment to date of death from any cause estimated by the median of the posterior normal probability distribution.
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Time of death or up to 2 years after the End of Treatment (EoT) visit.
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Duration of response (DR)
Time Frame: Disease assessment performed every 2 cycles of alectinib (each cycle is 28 days) and at EoT. After 24 weeks, it can be done every 3 cycles, on discussion with Sponsor. Follow-up visits are every 12 weeks after last dose of alectinib for up to 2 years.
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Duration of response, is defined as the time from the date of the first confirmed CR or PR according to RECIST 1.1 or ir-RECIST or standard imaging criteria for specific disease e.g.
RANO criteria to the date of disease progression.
The trial will report the median DR and 95% credible interval.
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Disease assessment performed every 2 cycles of alectinib (each cycle is 28 days) and at EoT. After 24 weeks, it can be done every 3 cycles, on discussion with Sponsor. Follow-up visits are every 12 weeks after last dose of alectinib for up to 2 years.
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Best percentage change in sum of target lesion / index lesion diameters (PCSD)
Time Frame: Disease assessment performed every 2 cycles (each cycle is 28 days). After 24 weeks, disease assessments can be repeated every 3 cycles, on discussion with Sponsor. Follow-up visits are every 12 weeks following last dose of alectinib for up to 2 years.
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PCSD is defined as the greatest decrease or least increase in the sum of target lesion diameters (RECIST) or index lesion diameters (irRECIST) as a percentage compared to the baseline measurement.
The trial will report the mean PCSD and 95% credible interval.
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Disease assessment performed every 2 cycles (each cycle is 28 days). After 24 weeks, disease assessments can be repeated every 3 cycles, on discussion with Sponsor. Follow-up visits are every 12 weeks following last dose of alectinib for up to 2 years.
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Time to treatment discontinuation (TTD)
Time Frame: From first dose of alectinib to discontinuation of trial treatment up to 5 years with an average calculated and presented with results entry.
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TTD is defined as the time from date of starting trial treatment to date of discontinuing trial treatment, in days estimated by the median of the posterior inverse gamma probability distribution.
The trial will report the median TTD and 95% credible interval.
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From first dose of alectinib to discontinuation of trial treatment up to 5 years with an average calculated and presented with results entry.
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Progression-Free Survival time (PFS)
Time Frame: Disease assessment performed every 2 cycles (each cycle is 28 days). After 24 weeks, it can be done every 3 cycles, on discussion with Sponsor. Follow-up visits take place every 12 weeks following last dose of alectinib for a period of up to 2 years.
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PFS is defined as the time from date of starting trial treatment to date of progression or date of death without a previous progression recorded estimated by the median of the posterior inverse gamma probability distribution.
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Disease assessment performed every 2 cycles (each cycle is 28 days). After 24 weeks, it can be done every 3 cycles, on discussion with Sponsor. Follow-up visits take place every 12 weeks following last dose of alectinib for a period of up to 2 years.
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Time to Progression (TTP)
Time Frame: Disease assessment performed every 2 cycles (each cycle is 28 days). After 24 weeks, it can be done every 3 cycles, on discussion with Sponsor. Follow-up visits take place every 12 weeks following last dose of alectinib for a period of up to 2 years.
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TTP is defined as the time from date of starting trial treatment to date of progression or date of death without recorded progression censored rather than events.
The trial will report the median TTP and 95% credible interval.
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Disease assessment performed every 2 cycles (each cycle is 28 days). After 24 weeks, it can be done every 3 cycles, on discussion with Sponsor. Follow-up visits take place every 12 weeks following last dose of alectinib for a period of up to 2 years.
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Growth Modulation Index (GMI)
Time Frame: Disease assessment performed every 2 cycles. After 24 weeks, it can be done every 3 cycles, on discussion with Sponsor. Follow-up visits take place every 12 weeks following last dose of alectinib for a period of up to 2 years.
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GMI is defined as the ratio of TTP with the trial protocol treatment to TTP on the most recent prior line of therapy.
The trial will report the mean GMI and 95% credible interval.
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Disease assessment performed every 2 cycles. After 24 weeks, it can be done every 3 cycles, on discussion with Sponsor. Follow-up visits take place every 12 weeks following last dose of alectinib for a period of up to 2 years.
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Occurrence of at least one Suspected Unexpected Serious Adverse Event (SUSAR)
Time Frame: From the time of consent until 28 days after last dose of alectinib (up to 5 years) or until patient starts another anti-cancer therapy, whichever came first. An average time frame will be presented with results entry.
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The trial will report the number of patients who experience at least one SUSAR to alectinib.
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From the time of consent until 28 days after last dose of alectinib (up to 5 years) or until patient starts another anti-cancer therapy, whichever came first. An average time frame will be presented with results entry.
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Occurrence of at least one Grade 3, 4 or 5 alectinib related AE
Time Frame: From the time of consent until 28 days after last dose of alectinib (up to 5 years) or until patient starts another anti-cancer therapy, whichever came first. An average time frame will be presented with results entry.
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Number of patients who experience at least one alectinib related Grade 3, 4 or 5 AE according to NCI CTCAE Version 5.0
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From the time of consent until 28 days after last dose of alectinib (up to 5 years) or until patient starts another anti-cancer therapy, whichever came first. An average time frame will be presented with results entry.
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EORTC-QLQ-30-Standardised Area Under Summary Score Curve (QLQSAUC) in adult participants.
Time Frame: QoL surveys performed at baseline every 2 cycles (every cycle is 28 days) and after interrupting treatment (up to 5 years).
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For adult populations, multiple measures of QoL will be generated from patient completion of the European Organisation for Research and Treatment of Cancer QLQC30 (EORTC-QLQC30) questionnaire (30 measures).
For each patient the Summary Score from the questionnaire will be generated at each time point and the area under the curve generated by these scores over time will be calculated and standardised by the time frame.
The trial will report the mean QLQSAUC and 95% credible interval.
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QoL surveys performed at baseline every 2 cycles (every cycle is 28 days) and after interrupting treatment (up to 5 years).
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EQ-5D Standardised Area Under Index Value Curve (EQ5DSAUC) in adult participants
Time Frame: QoL surveys performed prior to inclusion, every 2 cycles (each cycle is 28 days) and at EoT visit (up to 5 years).
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For adult populations, two measures of QoL will be generated from patient completion of the EQ-5D-5L questionnaire.
For each measure, scores based on responses from the questionnaire will be generated at each time point and the area under the curve generated by these scores over time will be calculated and standardised by the time frame.
The trial will report the mean EQ5DSAUC and 95% credible interval.
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QoL surveys performed prior to inclusion, every 2 cycles (each cycle is 28 days) and at EoT visit (up to 5 years).
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Mean change from baseline in the PedsQL 4.0 Standardised Area Under total Scale Score Curve (PedsSAUC) in paediatric participants.
Time Frame: QoL surveys performed prior to inclusion, every 2 cycles (each cycle is 28 days) and at EoT visit (up to 5 years).
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For paediatric populations multiple measures of QoL will be generated from patient completion of the, PedsQL 4.0 (4 measures).
The Summary Score from the questionnaire will be generated at each time point and the area under the curve generated by these scores over time will be calculated and standardised by the time frame.
The trial will report the mean PedsSAUC and 95% credible interval.
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QoL surveys performed prior to inclusion, every 2 cycles (each cycle is 28 days) and at EoT visit (up to 5 years).
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Mean change from baseline in the PedsQL 4.0 Standardised Area Under total Scale Score Curve (PedsSAUC) in parents from paediatric participants
Time Frame: QoL surveys performed prior to inclusion, every 2 cycles (each cycle is 28 days) and at EoT visit (up to 5 years).
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For paediatric populations multiple measures of QoL will be generated from patient's parent completion of the PedsQL 4.0 (4 measures).
The Summary Score from the questionnaire will be generated at each time point and the area under the curve generated by these scores over time will be calculated and standardised by the time frame.
The trial will report the mean PedsSAUC and 95% credible interval.
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QoL surveys performed prior to inclusion, every 2 cycles (each cycle is 28 days) and at EoT visit (up to 5 years).
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Matthew Krebs, Prof, The Christie Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Immune System Diseases
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma, Non-Hodgkin
- Neoplasms, Glandular and Epithelial
- Hematologic Diseases
- Neoplasms, Neuroepithelial
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Neuroectodermal Tumors, Primitive
- Neuroectodermal Tumors, Primitive, Peripheral
- Lymphoma, T-Cell
- Neoplasms
- Lymphoma
- Hematologic Neoplasms
- Neuroblastoma
- Lymphoma, Large-Cell, Anaplastic
- Lymphoproliferative Disorders
- Neoplasms by Site
- Neoplasms by Histologic Type
Other Study ID Numbers
- CRUKD/21/004 - Treatment Arm 1
- IRAS ID: 1004057 (Other Identifier: IRAS)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Neoplasms by Histologic Type
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Novatim Immune Therapeutics (Zhejiang) Co., Ltd.RecruitingNeoplasms | Neoplasms by Histologic TypeChina
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University of Colorado, DenverNational Cancer Institute (NCI)Recruiting
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Dana-Farber Cancer InstitutePfizerRecruiting
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University Hospital, Montpelliermooven societyTerminated
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Virginia Commonwealth UniversityNational Cancer Institute (NCI)TerminatedLeukemiaUnited States
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Southwest Hospital, ChinaUnknown
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University of LouisvilleJames Graham Brown Cancer CenterWithdrawn
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Peking University People's HospitalWithdrawn
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University of New MexicoNational Cancer Institute (NCI)WithdrawnLeukemiaUnited States
Clinical Trials on Alectinib
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Gruppo Oncologico Italiano di Ricerca ClinicaRecruiting
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Aarhus University HospitalRoche Pharma AGEnrolling by invitationLung Cancer | ALK Gene Mutation | Resistance, Disease | MutationDenmark
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Hoffmann-La RocheCompletedCarcinoma, Non-Small-Cell LungFrance
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Hoffmann-La RocheCompletedNon-Small Cell Lung CancerKorea, Republic of
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ETOP IBCSG Partners FoundationHoffmann-La RocheTerminatedNon-small Cell Lung Cancer | Non-small Cell Lung Cancer Metastatic | Non-small Cell Lung Cancer RecurrentIreland, Spain, Belgium, Italy, Netherlands, Switzerland
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Dana-Farber Cancer InstituteGenentech, Inc.TerminatedALK-positive Non-small Cell Lung Cancer (NSCLC) | RET-positive Non-small Cell Lung Cancer (NSCLC) | RET-positive Thyroid CancerUnited States
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University Medical Center GroningenRadboud University Medical Center; Maastricht University Medical Center; Erasmus... and other collaboratorsRecruitingCarcinoma, Non-Small-Cell Lung | Lung Cancer | Drug Monitoring | Anaplastic Lymphoma Kinase Gene Mutation | Anaplastic Lymphoma Kinase Gene TranslocationNetherlands, France
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Hoffmann-La RocheActive, not recruitingNSCLCBelgium, Australia, China, Croatia, Finland, Turkey, Italy, Israel, Serbia, Austria, Romania, Peru, Lithuania, Colombia, Portugal, Czechia, Cuba, Russian Federation, Bulgaria, Vietnam, Uruguay, United Arab Emirates, Argentina, Chile, Pa...
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PfizerCompletedNon-Small-Cell Lung CarcinomaUnited States
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Hoffmann-La RocheCompletedHepatic ImpairmentCzechia, Slovakia