A Study of BBI503 in Adult Patients With Advanced Gastrointestinal Stromal Tumors
This is an open label, multi-center, phase II study of BBI503 administered to adult patients with advanced gastrointestinal stromal tumor who have exhausted all currently approved standard anti-cancer treatment options. BBI503 will be administered orally, daily, in continuous 28-day cycles at a dose of 300 mg once daily. Cycles will be repeated until patients are no longer clinically benefiting from therapy due to disease progression, adverse events, or another discontinuation criterion.
Safety, tolerability and efficacy of BBI503 will be assessed for the duration of study treatment.
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Phase II Clinical Study of BBI503 in Adult Patients With Advanced Gastrointestinal Stromal Tumors|
- Disease Control Rate (DCR) [ Time Frame: 8 weeks ]Defined as the proportion of patients with a documented complete response, partial response, and stable disease (CR + PR + SD) based on RECIST 1.1.
- Objective Response Rate (ORR) [ Time Frame: 8 weeks ]Defined as the proportion of patients with a documented complete response and partial response (CR + PR) based on RECIST 1.1.
- Progression Free Survival (PFS) [ Time Frame: 24 months ]Defined as the time from enrollment to the first objective documentation of disease progression or death due to any cause.
- Overall Survival (OS) [ Time Frame: 24 months ]Defined as the time from enrollment to death due to any cause.
- Number of Patients with Adverse Events [ Time Frame: 24 months ]All patients who have received at least one dose of BBI503 will be included in the safety analysis. The incidence of adverse events will be summarized by type of adverse event and severity.
- Pharmacodynamics (biomarkers) of BBI503 when tumor biopsy is possible [ Time Frame: baseline, 4 weeks ]
|Actual Study Start Date:||March 13, 2017|
|Estimated Study Completion Date:||December 2019|
|Estimated Primary Completion Date:||December 2018 (Final data collection date for primary outcome measure)|
BBI503 will be administered orally, daily, in continuous 28-day cycles at a dose of 300 mg once daily.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02232620
|Contact: Boston Biomedical||617-674-6800|
|Princess Margaret Cancer Centre||Recruiting|
|Toronto, Ontario, Canada, M5G 2M9|
|Contact: Sukhi Brah, CRC 416-946-4501 ext 3981 firstname.lastname@example.org|