TRIAL DETAIL

A Study of BBI503 in Adult Patients With Advanced Gastrointestinal Stromal Tumors

Drug:
Trial Name:
A Study of BBI503 in Adult Patients With Advanced Gastrointestinal Stromal Tumors
NCT#:
Conditions:
Gastrointestinal Stromal Tumor
Status:
Terminated
Phase:
1
Start Date 03/13/2017
Age of Trial (yrs) 5.4
Treatment Phase:
Gleevec-resistant
Drug Category:
Stem Cell inhibitor
Strategy:
Inhibits Stem Cell survival
Trial Type:
Specifically GIST and only GIST
Other Protocol IDs:
BBI503-205c
Sponsor:
Boston Biomedical, Inc
Patient Contact:
Boston Biomedical 617-674-6800
Contact email:
Contact Phone:
Randomized:
IV or Oral:
Oral
Trial Notes:
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.

Inclusion Criteria:



A patient with gastrointestinal stromal tumor (GIST) must also meet the following criteria:

Must have either positive immunostaining for the CD117-antigen, or contain a GIST associated KIT or PDGFR-α mutation.
Must have disease which is metastatic or locally advanced and unresectable
Must have received prior treatment with imatinib and sunitinib, and must have had disease progression during treatment with these agents, have had documented intolerance to these agents, or not be candidates for treatment with these agents.
Must have also failed or not be eligible for treatment with regorafenib.

Trial Links

Trial Results

Drug Information

Trial Sites

Name
Address
City
State
Zip
Country
610 University Ave
Toronto
ON
M5G 2M9
Canada