- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01222546
Study of CH5132799 Administered Orally in Patients With Advanced Solid Tumors
June 20, 2014 updated by: Chugai Pharma Europe Ltd.
Phase I, Open-label, Multi-center, Dose-escalation Study to Evaluate Safety, Pharmacokinetics and Activity of CH5132799 Administered Orally as a Monotherapy in Patients With Advanced Solid Tumors
This is an open-label, multi-center, dose-escalation Phase I study to evaluate safety, pharmacokinetics and activity of CH5132799 administered orally as a single agent in patients with advanced solid tumors.
Study Overview
Study Type
Interventional
Enrollment (Actual)
38
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Leeds
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London, Leeds, United Kingdom
- Investigator Sites
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Provision of signed written informed consent.
- Histologically or cytologically confirmed diagnosis of advanced solid tumor.
- Age ≥ 18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
- Life expectancy of ≥ 12 weeks.
Disease measurability:
Patients must have a measurable - as per Response Evaluation Criteria in Solid Tumours (RECIST) criteria version 1.1 - and/or evaluable disease.
- Paraffin-embedded archival tumor tissue available. Fresh biopsies will be required if no paraffin embedded tumor tissues available.
- Adequate bone marrow function.
- Adequate cardiac function: Patient should have Left Ventricular Ejection Fraction (LVEF) of ≥ 50% as determined by echocardiography (ECHO) or Multi Gated Acquisition (MUGA) scans.
- Adequate liver function.
- Adequate renal function.
- Adequate adrenal function assessed by baseline cortisol of > 200 nmol/L
- Ability to comply with protocol requirements.
- Female patients must be postmenopausal (12 months of amenorrhea), surgically sterile or they must agree to use a physical method of contraception. Male patients who have been sterilized must agree to use a barrier method of contraception. Male subjects must also commit to use a barrier method of contraception until at least 3 months after the end of study treatment.
- Female patients of child-bearing potential must have a negative serum pregnancy test within the seven days prior to the first study drug administration.
Exclusion Criteria:
- History of allergic reactions attributed to components of the formulated product.
- Inability to swallow oral medications or impaired gastrointestinal absorption due to active inflammatory bowel disease.
- Known Central Nervous System (CNS) metastases or leptomeningeal metastases will be eligible only if it could be radiologically demonstrated that there is no CNS disease progression during the 3 months prior to the study
- Known active or uncontrolled pulmonary dysfunction.
- Uncontrolled hypertension
- Prior chemotherapy, radiotherapy (other than short cycle of palliative radiotherapy for bone pain), or immunotherapy within 28 days of first receipt of study drug (within 6 weeks for nitrosoureas and mitomycin C). Hormone therapy within 14 days of first receipt of study drug, with exception of prostate cancer if indicated.
- Prior toxicities from chemotherapy or radiotherapy which have not regressed to Grade ≤ 1 severity - National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE version 4.0).
- Type 1 or 2 diabetes mellitus requiring regular medication and/or a fasting plasma glucose (FPG) ≥ 120 mg/dL (or 6.6 mmol/dL) at screening.
- Increased QTc interval (QTc > 450 ms for male; > 460 ms for female).
- History of heart failure, refractory hypokalemia to adequate supplementation, family history of long QT syndrome or other risk factors for "Torsades de Pointes", and/or the use of concomitant medications that prolong the QT/QTc interval.
- Prior corticosteroid therapy within 14 days of first receipt of study drug.
- Treatment with any investigational agent within 28 days of first receipt of study drug.
- Acute or chronic infection. Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding or any other medical condition that, in the opinion of the investigator, contraindicates the use of an investigational drug, or will impose excessive risk to the patient.
- Known Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV) infection.
- History of clinically significant bowel disease including abdominal fistula, gastro-intestinal perforation, and diverticulitis.
- Major surgery within 28 days of first receipt of study drug.
- Pregnant or lactating women
- Altered mental status or psychiatric disorder that, in the opinion of the investigator, would preclude a valid patient informed consent.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: CH5132799
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Occurrence of dose limiting toxicities
Time Frame: Upon completion of the study
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Upon completion of the study
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Preliminary anti-tumour activity
Time Frame: Upon completion of the study
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Upon completion of the study
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To determine the pharmacokinetics of CH5132799
Time Frame: Upon completion of the study
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Upon completion of the study
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To characterise the pharmacodynamic effect of CH5132799 in surrogate tissues
Time Frame: Upon completion of the study
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Upon completion of the study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2010
Primary Completion (Actual)
November 1, 2012
Study Completion (Actual)
December 1, 2012
Study Registration Dates
First Submitted
October 14, 2010
First Submitted That Met QC Criteria
October 15, 2010
First Posted (Estimate)
October 18, 2010
Study Record Updates
Last Update Posted (Estimate)
June 23, 2014
Last Update Submitted That Met QC Criteria
June 20, 2014
Last Verified
June 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PA-001EU
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.
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