A Study of BBI503 in Adult Patients With Advanced Hepatobiliary Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02232633|
Recruitment Status : Active, not recruiting
First Posted : September 5, 2014
Last Update Posted : January 24, 2018
This is an open label, multi-center, phase II study of BBI503 administered to adult patients with advanced hepatobiliary cancer 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.
Safety, efficacy and tolerability of BBI503 will be assessed for the duration of study treatment.
|Condition or disease||Intervention/treatment||Phase|
|Hepatocellular Carcinoma Cholangiocarcinoma||Drug: BBI503||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Clinical Study of BBI503 in Adult Patients With Advanced Hepatobiliary Cancer|
|Study Start Date :||February 2015|
|Estimated Primary Completion Date :||December 2018|
BBI503 will be administered orally, daily, in continuous 28-day cycles at a dose of 300 mg once daily
- 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.
- Pharmacodynamics (biomarkers) of BBI503 when tumor biopsy is possible [ Time Frame: baseline, 4 weeks ]
- 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.
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): NCT02232633
|University of Calgary|
|Calgary, Alberta, Canada, T2N 4N2|
|The Ottawa Hospital Cancer Centre|
|Ottawa, Ontario, Canada, K1H 8L6|
|Princess Margaret Hospital|
|Toronto, Ontario, Canada|