- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01337401
A Trial of Cediranib in the Treatment of Patients With Alveolar Soft Part Sarcoma (CASPS) (CASPS)
A Phase II Trial of Cediranib in the Treatment of Patients With Alveolar Soft Part Sarcoma (CASPS)
The study is a two-arm, randomised, double-blind, international, multi-centre phase II trial of cediranib in Alveolar Soft Part Sarcoma (ASPS).
The study aims to confirm the ability of cediranib to halt disease progression in patients with metastatic ASPS, as measured by the change in tumour size at 24 weeks after randomisation, and to produce objective response according to RECIST criteria.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Brisbane, Australia
- Princess Alexandra Hospital
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Sydney, Australia
- Royal Prince Alfred Hospital
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Barcelona, Spain
- Hospital Santa Cruz i Sant Pau
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Madrid, Spain
- Hospital Puerta de Hierro
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Zaragoza, Spain
- Hospital Miguel Servet
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Bristol, United Kingdom
- Bristol Haematology and Oncology Centre
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London, United Kingdom
- University College London Hospital
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London, United Kingdom
- Royal Marsden Hospital
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Manchester, United Kingdom
- Christie Hospital
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Newcastle-Upon-Tyne, United Kingdom
- Royal Victoria Infirmary/Freeman Hospital
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Nottingham, United Kingdom
- Nottingham University Hospitals
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Histologically confirmed diagnosis of ASPS (central confirmation not required at study entry)
- Age 16 years and older
- Availability of archived tissue blocks or unstained slides to enable confirmation of t(X;17) translocation
- ECOG Performance Status of 0-1
- Life expectancy of >12 weeks
- Progressive disease as defined by RECIST v1.1 within 6 months prior to randomisation
- Measurable metastatic disease using RECISTv1.1, i.e. at least one lesion 10 mm in diameter (15 mm in short axis for nodal lesions) assessable by CT (or MRI for brain metastases).
- Patients with brain metastases are permitted provided disease is controlled with a stable dose of corticosteroid and/or non-enzyme inducing anticonvulsant
- The capacity to understand the patient information sheet and ability to provide written informed consent
- Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other study procedures
- Able to swallow and retain oral medication
Exclusion Criteria:
- Inadequate bone marrow reserve as demonstrated by an absolute neutrophil count ≤1.5 x 109/L or platelet count ≤100 x 109/L
- Serum bilirubin ≥ 1.5 x ULN (unless Gilbert's syndrome)
- ALT or AST ≥ 2.5 x ULN. If liver metastases are present, ALT or AST > 5 x ULN
- Serum creatinine > 1.5 x ULN or a creatinine clearance (calculated or measured) of ≤ 50mL/min
- Greater than +1 proteinuria unless urinary protein < 1.5g in a 24 hr period or protein/creatinine ratio < 1.5.
- History of significant gastrointestinal impairment, as judged by the Investigator, that would significantly affect the absorption of cediranib.
- Patients with a history of poorly controlled hypertension with resting blood pressure >150/100 mmHg in the presence or absence of a stable regimen of anti-hypertensive therapy.
- Any evidence of severe or uncontrolled co-morbidities e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease, or active and uncontrolled infection.
- Evidence of prolonged QTc >480 msec (using Bazetts correction, for which the formula is: QTc = QT/√RR) or history of familial long QT syndrome.
- Significant recent haemorrhage (>30mL bleeding/episode in previous 3 months) or haemoptysis (>5mL fresh blood in previous 4 weeks).
- Major thoracic or abdominal surgery in the 14 days prior to entry into the study, or a surgical incision that is not fully healed.
- Pregnant or breast-feeding women; women of childbearing potential with a positive pregnancy test prior to receiving study medication; women the intention of pregnancy during study treatment; women of child bearing potential unwilling to have a urine or serum pregnancy test prior to study entry (even if surgically sterilised).
- Men and women of childbearing potential unwilling to use adequate birth control measures (e.g. abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, implantable or injectable contraceptives or surgical sterilisation) for the duration of the study and should continue such precautions for 2 weeks after receiving the last study treatment.
- History of anticancer (including investigational, non-registered) treatment in the four weeks prior to first dose of cediranib, with the exception of palliative radiotherapy for symptom control.
- Previous treatment with cediranib.
- Known hypersensitivity to any excipient of cediranib.
- History of other malignancies (except for adequately treated basal or squamous cell carcinoma or carcinoma in situ) within 5 years, unless the patient has been disease free for 2 years and there is a tissue diagnosis of the primary cancer of interest from a target lesion.
- Other concomitant anti-cancer therapy (including LHRH agonists) except steroids
- Recent history of thrombosis
- Patients with brain metastases if they are symptomatic requiring increasing steroids in the previous six weeks to study entry or those with evidence of recent and/or active bleeding, or those causing uncontrolled seizures.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Blinded Cediranib
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30mg once daily, oral until disease progression
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Placebo Comparator: Blinded Placebo
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30mg, once daily, oral until 24 weeks or disease progression if sooner
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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To evaluate the efficacy of cediranib in the treatment of ASPS by measuring the percentage change in the sum of target marker lesion diameters from randomisation to week 24 (or progression if sooner) compared to treatment with placebo.
Time Frame: 24 Weeks of treatment
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24 Weeks of treatment
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Response rate at week 24, best response using RECISTv1.1 and best reduction (%) in tumour size
Time Frame: 24 Weeks of treatment
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24 Weeks of treatment
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Progression-free survival and percentage alive and progression-free at 12 months (APF12)
Time Frame: 12 months of treatment
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12 months of treatment
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Length of Overall survival
Time Frame: Patients will be followed up every 12 weeks
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Patients will be followed up every 12 weeks
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The safety and tolerability profile of cediranib in patients with ASPS
Time Frame: Assessments will be made at every study visit (8-12 weekly)
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Assessments will be made at every study visit (8-12 weekly)
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Collaborators and Investigators
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ICR-CTSU/2010/10027
- 2010-021163-33 (EudraCT Number)
- CRUK/10/021 (Other Grant/Funding Number: Cancer Research UK)
- ISRCTN63733470 (Registry Identifier: Randomised controlled Trials)
- ISSRECE0036 (Other Grant/Funding Number: AstraZeneca)
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 Alveolar Soft-part Sarcoma
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National Cancer Institute (NCI)RecruitingMetastatic Alveolar Soft Part Sarcoma | Unresectable Alveolar Soft Part Sarcoma | Advanced Soft Tissue Sarcoma | Advanced Alveolar Soft Part SarcomaUnited States
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National Cancer Institute (NCI)RecruitingMetastatic Alveolar Soft Part Sarcoma | Unresectable Alveolar Soft Part SarcomaUnited States
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Seoul National University HospitalSamsung Medical Center; Asan Medical Center; Seoul National University Bundang... and other collaboratorsTerminatedMetastatic Alveolar Soft Part SarcomaKorea, Republic of
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National Cancer Institute (NCI)Active, not recruitingSarcoma, Alveolar Soft PartUnited States
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Genor Biopharma Co., Ltd.RecruitingAlveolar Soft Part SarcomaChina
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AEterna ZentarisSarcoma Alliance for Research through CollaborationCompletedChondrosarcomas | Alveolar Soft Part Sarcomas | Extra Skeletal Myxoid Chondrosarcomas
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National Cancer Institute (NCI)CompletedSarcoma | Alveolar Soft Part SarcomaUnited States
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Advenchen Laboratories, LLCActive, not recruitingLeiomyosarcoma | Synovial Sarcoma | Alveolar Soft Part Sarcoma | Soft-Tissue SarcomaUnited States, United Kingdom, Spain, China, Italy
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Jonathan Trent, MD, PhDMerck Sharp & Dohme LLC; PfizerCompletedAlveolar Soft Part Sarcoma | Soft Tissue SarcomasUnited States
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