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

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

Gastrointestinal Stromal Tumor

Terminated

1

Start Date 03/13/2017

Age of Trial (yrs) 7.1

Gleevec-resistant

Stem Cell inhibitor

Inhibits Stem Cell survival

Specifically GIST and only GIST

BBI503-205c

Boston Biomedical, Inc

Boston Biomedical 617-674-6800

Oral

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.