A Safety, Tolerability and PK Study of DCC-2618 in Patients With Advanced Malignancies

A Safety, Tolerability and PK Study of DCC-2618 in Patients With Advanced Malignancies

Gastrointestinal Stromal Tumor

Active, not recruiting

1

Start Date 10/30/2015

Age of Trial (yrs) 8.5

Gleevec-resistant

KIT/PDGFRA inhibitor

Block KIT

Specifically GIST plus other cancers

DCC-2618-01-001

Deciphera Pharmaceuticals

Jama Pitman jpitman@deciphera.com clinicaltrials@deciphera.com

Oral

This is a Phase 1, open-label, first-in-human (FIH) dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary antitumor activity of DCC-2618, administered orally (PO), in adult patients with advanced malignancies. The study consists of 2 parts, a dose-escalation phase and an expansion phase.

Inclusion Criteria: Patients with solid tumor or hematologic malignancy must have a histologically confirmed, locally advanced malignancy refractory or intolerant to standard therapies and/or have no alternative effective therapy available, with the following exceptions: GIST patients must have progressed at least on imatinib.