- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01184807
Phase 1, Dose-escalation Trial of OPB-51602 in Patients With Advanced Solid Tumors
March 24, 2014 updated by: Otsuka Beijing Research Institute
A Phase 1, Open-label, Non-randomized, Dose-escalation Trial of OPB-51602 in Patients With Advanced Solid Tumors
This is an open-label, non-randomized, dose-escalation trial in patients with advanced solid tumors.
The trial comprises 2 stages: a dose escalation stage at 8 dose levels of 2, 5, 10, 20, 40, 60, 80, and 100 mg/day,and possibly additional intermediate doses, to determine the MTD and recommended dose, and a subsequent 2 parts of expansion stage to investigate the safety profile and antitumor effect of OPB-51602 at the recommended dose.
Study Overview
Detailed Description
In expansion stage part 1, up to 20 advanced sold tumor subjects will be investigated the safety profiled and antitumor effect of OPB-51602 at the recommended dose for 3 weeks per cycle(2 weeks treatment and 1 week washout).
In the expansion stage part 2, a maximum of 20 subjects with Non-small cell lung cancer (NSCLC), Melanoma or Gastrointestinal Stromal Tumor (GIST) will be treated until an investigational Medicinal product (IMP) efficacious case can be found.
subject dosing will be started on Day 1 without 2-day treatment free interval and continued until Day 28 at recommend dose (4mg) first in cycle 1.
After safety and tolerability are confirmed, same subjects will be treated at the MTD(5mg) from cycle 2 onwards as a once-daily oral dose for 4 weeks per cycle to obtain additional information about safety, tolerability and antitumor activity of OPB-51602
Study Type
Interventional
Enrollment (Actual)
51
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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Singapore, Singapore, 119074
- National University Hospital (s) PTE LTD.
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Singapore, Singapore, 160610
- National Cancer Centre, Department of Medical Oncology
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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
21 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients with pathologically confirmed, locally advanced or metastatic solid tumors who are unresponsive to standard therapy or for whom standard therapy is intolerable or unsuitable
- Age: ≥21 years (at time of informed consent)
- ECOG performance status: ≤2 (Appendix 1)
- Life expectancy of longer than 3 months
Adequate vital organ function as follows:
- Bone marrow function Neutrophils: ≥1,500/μL, platelets: ≥75,000/μL, hemoglobin: ≥9.0 g/dL
- Hepatic function Aspartate transaminase (AST) and alanine transaminase(ALT): ≤2.5 ×institutional upper limit of normal(ULN) or ≤5.0 × institutional ULN if there is liver metastasis, serum total bilirubin: <2.5 × institutional ULN
- Renal function Serum creatinine: <1.5 × institutional ULN
- Capable of swallowing OPB-51602 tablets
- Ability to understand and willingness to sign written informed consent form (ICF) for participation in the trial
- No chemotherapy, radiotherapy, surgery, immunotherapy, or other therapy within 4 weeks prior to start of investigational medicinal product (IMP) administration and recovered from any prior toxicity
- If a subject has received more than 5 regimens of previous chemotherapy, the investigator must discuss with the sponsor regarding subject suitability prior to enrollment.
Exclusion Criteria:
- Uncontrolled central nervous system (CNS) metastasis
- Uncontrolled concurrent illness, including active infection, angina pectoris, cardiac arrhythmia, or heart failure (NYHA class III or IV, Appendix 2 New York Heart Association (NYHA) functional classification)
- Concurrent malignancy of a different type
- Immunocompromised subjects, including those who are known to be infected with human immunodeficiency virus (HIV)
- Psychiatric illness that would limit compliance with trial requirements
- Pregnant or breast-feeding women
- Women of childbearing potential (WOCBP) or male subjects whose partners are WOCBP who cannot or will not use effective contraceptive measures
- Administration of another investigational agent within 6 weeks prior to start of IMP administration
- Use of any of the prohibited medications and other substances listed in Appendix 3 CYP3A4 Inhibitors and Inducers within either 1 week prior to start of IMP administration or a period of at least 5 times the respective elimination halflife, whichever is longer
- Known severe gastrointestinal disorder, including malabsorption (at screening)
- Patients with CTCAE Grade 1 or higher pneumonitis (interstitial pneumonia) or pulmonary fibrosis* * If interstitial lung abnormalities, (e.g. ground-glass or linear opacity) are suspected on chest CT scan (high-resolution CT), regardless of whether or not there are any accompanying symptoms it must be confirmed, such as through consultation with a respiratory or radiology expert if necessary, that the patient dose not fall under this exclusion criterion before the patient can be enrolled in the trial.
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: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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OTHER: OPB-51602
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OPB-51602 at a dose of 2, 5, 10, 20, 40, 60, 80, or 100 mg/day,will be orally administered to subjects once daily for 2 weeks in each cycle of treatment in Dose Escalation Stage.A 2-day treatment-free interval will occur on Days 2 and 3 for PK sampling.
Study drug administration will resume on Day 4 and continue until Day 17 in cycle 1.In Expansion stage part 1, OPB-51602 will be administered at recommend dose (4mg) for 3 weeks per cycle 9 2 weeks treatment and 1 week washout).
There is also 2-day treatment free interval between Day 1 and Day 4 for PK sampling in cycle 1.In Expansion stage part 2, subject dosing will be started on Day 1 without 2-day treatment free interval and continued until Day 28 at recommend dose (4mg) first in Cycle 1.
The same subjects will be treated at MTD(5mg)from cycle 2 onwards for 4 weeks per cycle.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
safety and tolerability
Time Frame: 3 weeks
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AEs, vital signs, body weight, ECG, clinical laboratory tests, and ECOG performances status in the first cycle of treatment
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3 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pharmacokinetics
Time Frame: duration of the treatment
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plasma and urinary concentrations of OPB-51602 and its metabolites
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duration of the treatment
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safety and tolerability
Time Frame: duration of treatment
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AEs, vital signs, body weight, ECG, clinical laboratory tests, and ECOG performances status in all treatment cycles.
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duration of treatment
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efficacy
Time Frame: duration of treatment
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Response and progression evaluated using Response Evaluation criteria in solid tumors (RECIST)
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duration of treatment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Goh Boon Cher, Dr, Department of Haematology-Oncology,National University Hospital
- Principal Investigator: Daniel Tan shao Weng, MD, PhD, National Cancer Centre, Singapore
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
December 1, 2009
Primary Completion (ACTUAL)
June 1, 2013
Study Completion (ACTUAL)
June 1, 2013
Study Registration Dates
First Submitted
August 17, 2010
First Submitted That Met QC Criteria
August 18, 2010
First Posted (ESTIMATE)
August 19, 2010
Study Record Updates
Last Update Posted (ESTIMATE)
March 26, 2014
Last Update Submitted That Met QC Criteria
March 24, 2014
Last Verified
March 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 266-09-801-01
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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