Refractory Tumor Clinical Trial
Official title:
Phase IIa Dose-Expansion and Biomarker Study of OPB-111077 in An Enriched Population of Treatment-Refractory Advanced Solid Tumors
This is a phase IIa open-label, non-randomized dose-expansion study of OPB-111077 in patients with advanced, treatment refractory cancers who have biopsy-amenable lesions at study entry.
This is a phase IIa open-label, non-randomized dose-expansion study of OPB-111077 in
patients with advanced, treatment refractory cancers who have biopsy-amenable lesions at
study entry. Patients on the proposed study will be treated with the RPII dose of OPB-111077
(600mg on a 4 days-on, 3 days-off per week schedule). They will be enrolled in two parallel
cohorts: i. patients with tumors predicted to be dependent on oxidative phosphorylation
metabolism or oncogene addicted tumors which have developed resistance to primary TKI
therapy, or ii. patients with nasopharyngeal carcinoma
Each cohort will contain 11-26 patients, over a period of 12-36 months. Subjects will
receive OPB-111077 in 28-day cycles till disease progression or intolerable toxicity.
Mandatory tumour biopsies will be performed at baseline and on cycle 1 day 15 (where
feasible and accessible). Circulating biomarker blood sampling will be performed on days 1,
11 and 15 of cycle 1, and upon completion of OPB-111077 dosing. Pharmacokinetics blood
sampling will be performed on days 11 and 15 of cycle 1. Safety assessments will be
performed on cycle 1 day 1, cycle 1 day 8, cycle 1 day 15, bi-weekly till week 8, then
monthly thereafter and response assessments will be performed every 8 weeks. Metabolic
response assessment by PET/CT will be performed after 2 cycles of treatment, while
radiologic response assessment will be performed after every 2 cycles of OPB-111077 from
cycle 4 onwards.
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