Phase IIa Dose-Expansion and Biomarker Study of OPB-111077
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|ClinicalTrials.gov Identifier: NCT03158324|
Recruitment Status : Recruiting
First Posted : May 18, 2017
Last Update Posted : June 15, 2017
|Condition or disease||Intervention/treatment||Phase|
|NPC Refractory Tumor||Drug: OPB-111077||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||52 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Two parallel cohorts will be implemented: 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|
|Masking:||None (Open Label)|
|Official Title:||Phase IIa Dose-Expansion and Biomarker Study of OPB-111077 in An Enriched Population of Treatment-Refractory Advanced Solid Tumors|
|Actual Study Start Date :||May 22, 2017|
|Estimated Primary Completion Date :||May 22, 2020|
|Estimated Study Completion Date :||November 30, 2020|
Experimental: Advanced refractory solid tumors
Patients with advanced refractory solid tumors will be enrolled.
Receive 600 mg of OPB-111077 on a 4 days-on, 3 days-off per week in 28-day cycles till disease progression or intolerable toxicity
- Objective response rates [ Time Frame: 3 years ]This will be calculated as the percentage of evaluable patients achieving complete and partial response with OPB-111077 treatment, according to the RECIST 1.1 criteria
- Metabolic response rates [ Time Frame: 3 years ]This will be calculated as the percentage of evaluable patients achieving complete and partial metabolic response on 18F]-FDG PET/CT after 2 cycles of OPB-111077, as determined by the EORTC PET response criteria.
- Progression free survival [ Time Frame: 3 years ]This is defined as the time from the start of study treatment to documented progression of disease or death.
- Haematologic and non-haematologic toxicities (all grades) [ Time Frame: 3 years ]To evaluate the haematologic and non-haematologic toxicities of OPB-111077
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03158324
|Contact: Andrea Wong, MBBS||(65) 6779 email@example.com|
|Contact: Boon Cher Goh, MBBS||(65) 6779 firstname.lastname@example.org|
|National University Hospital, Singapore||Recruiting|
|Singapore, Singapore, 119228|
|Contact: Andrea Wong, MBBS +65 6772 4621 Andrea_LA_Wong@nuhs.edu.sg|
|Sub-Investigator: Boon Cher Goh, MBBS|