The purpose of this study is to determine the tolerability profile of OPB-111001 and to determine the most suitable dose of OPB-111001 in patients with advanced cancer
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
79
The Institute of Cancer Research, Royal Marsden NHS Foundation Trust
London, Sutton, Surrey, United Kingdom
NIHR/Wellcome Trust Imperial CRF/Imperial College Healthcare NHS Trust, Imperial Centre for Translational and Experimental Medicine (L-Block), Hammersmith Hospital
London, United Kingdom
Maximum tolerated dose / Recommended Phase 2 dose; Tolerability
Time frame: after 2 or 6 weeks depending on study part; continously
Pharmacokinetic parameters for OPB-111001 and its metabolites
Frequent sampling during Cycle 1 to 3, D1 only from Cycle 4 onwards
Time frame: repeatedly until end of study (average of 3 months assumed)
Assessment of antitumor activity as defined by Response Evaluation Criteria in Solid Tumours (RECIST)
Time frame: repeatedly every 8th week until end of study (average of 3 months assumed)
Prostate-specific antigen (PSA) response in patients with prostate cancer
Time frame: repeatedly (Cycle 1 to 3 on Day 1, then every 4th week) until end of study (average of 3 months assumed)
Cancer antigen 125 (CA 125) response in patients with ovarian cancer
Time frame: repeatedly (Cycle 1 to 3 on Day 1, then every 4th week) until end of study (average of 3 months assumed)
Time to treatment failure
Time frame: At end of study (after average of 3 months assumed)
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