A Study of DCC-2618 vs Sunitinib in Advanced GIST Patients After Treatment With Imatinib (intrigue)

A Study of DCC-2618 vs Sunitinib in Advanced GIST Patients After Treatment With Imatinib (intrigue)

Gastrointestinal Stromal Tumor

Active, not recruiting

3

Start Date 02/11/2019

Age of Trial (yrs) 6.1

Gleevec-resistant

KIT/PDGFRA inhibitor

Block KIT

Specifically GIST and only GIST

DCC-2618-03-002

Deciphera Pharmaceuticals LLC

Clinical Team 785-830-2100 clinicaltrials@deciphera.com

Randomized

Oral

Inclusion Criteria:

Patients ≥ 18 years of age at the time of informed consent.
Histologic diagnosis of GIST and must be able to provide an archival tumor tissue sample, otherwise, a fresh biopsy is required.
Molecular pathology report must be available. If molecular pathology report is not available or insufficient, an archival tumor tissue sample or fresh biopsy is required for mutation status confirmation by the central laboratory prior to randomization.
Patients must have progressed on imatinib or have documented intolerance to imatinib.
Eastern Cooperative Oncology Group (ECOG) PS of ≤ 2 at screening.
Female patients of childbearing potential must have a negative serum beta-human chorionic gonadotropin (β-hCG) pregnancy test at screening and negative pregnancy test at Cycle 1 Day 1 prior to the first dose of study drug.
Patients of reproductive potential must agree to follow the contraception requirements outlined in the study protocol.
Patients must have at least 1 measurable lesion according to mRECIST Version 1.1 (non nodal lesions must be ≥ 1.0 cm in the long axis or ≥ double the slide thickness in the long axis) within 21 days prior to the first dose of study drug.
Adequate organ function and bone marrow reserve as indicated by the central laboratory assessments performed at screening.
Resolution of all toxicities from prior therapy to ≤ Grade 1 (or patient baseline) within 1 week prior to the first dose of study drug (excluding alopecia and ≤ Grade 3 clinically asymptomatic lipase, amylase, and creatine phosphokinase [CPK] laboratory abnormalities).
The patient is capable of understanding and complying with the protocol and has signed the informed consent document. Signed informed consent form (ICF) must be obtained before any study-specific procedures are performed.

Exclusion Criteria:

Treatment with any other line of therapy in addition to imatinib for advanced GIST.