Phase 1, Dose-escalation Trial of OPB-51602 in Patients With Advanced Solid Tumors

• Status: Completed
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Otsuka Beijing Research Institute

Criteria

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:

1. Bone marrow function Neutrophils: ≥1,500/μL, platelets: ≥75,000/μL, hemoglobin:

≥9.0 g/dL

2. 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

3. 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.