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

Completed · Phase 1

Conditions studied: Gastrointestinal Stromal Tumors, Advanced Systemic Mastocytosis, Advanced Cancers

In brief

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. All active patients (from both dose-escalation and expansion phases) will then transition into an extension phase.

Key facts

Study ID

NCT02571036

Run by

Deciphera Pharmaceuticals, LLC

People needed

282

Starts

2015-11-01

Expected to finish

2022-04-29

Last updated by the study team

2023-12-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

Where it is running

• Honor Health (GIST, mastocytosis, other solid tumors) — Scottsdale, Arizona, United States
• UCLA Hematology Center (mastocytosis) — Los Angeles, California, United States
• UCLA (glial malignancies only) — Los Angeles, California, United States
• Stanford University Comprehensive Cancer Center (GIST) — Palo Alto, California, United States
• Stanford University Hematology Clinic (mastocytosis) — Palo Alto, California, United States
• UCSF (glial malignancies only) — San Francisco, California, United States
• Mayo Clinic (GIST, mastocytosis, glial malignancies, other solid tumors) — Jacksonville, Florida, United States
• University of Miami (GIST, mastocytosis, glial malignancies, other solid tumors) — Miami, Florida, United States
• Dana Farber Cancer Institute (GIST, mastocytosis, glial malignancies, other solid tumors) — Boston, Massachusetts, United States
• Colombia University Medical Center (mastocytosis) — New York, New York, United States
• Memorial Sloan Kettering Cancer Center (GIST, mastocytosis, glial malignancies, other solid tumors) — New York, New York, United States
• OHSU (GIST & mastocytosis only) — Portland, Oregon, United States
• Fox Chase Cancer Center (GIST only) — Philadelphia, Pennsylvania, United States
• MD Anderson Cancer Center (GIST, mastocytosis, glial malignancies, other solid tumors) — Houston, Texas, United States
• Huntsman Cancer Institute (GIST, mastocytosis, glial malignancies, other solid tumors) — Salt Lake City, Utah, United States
• Virginia Commonwealth University School of Medicine (mastocytosis) — Richmond, Virginia, United States
• Princess Margaret Cancer Centre (GIST, other solid tumors) — Toronto, Canada
• Uniklinik RWTH Aachen (mastocytosis, GIST, and other solid tumors) — Aachen, Germany
• HELIOS Klinikum Berlin-Buch (GIST, and other solid tumors) — Berlin, Germany
• Essen University Hospital (mastocytosis, GIST, and other solid tumors) — Essen, Germany
• Freiburg University Hospital (mastocytosis, and other solid tumors) — Freiburg im Breisgau, Germany
• University Medical Centre Mannheim (mastocytosis) — Mannheim, Germany
• University Hospital of Verona (mastocytosis) — Verona, Italy
• Leiden University Medical Center (GIST and other solid tumors) — Leiden, Netherlands
• Guy's Hospital (mastocytosis only) — London, United Kingdom

Full record on ClinicalTrials.gov

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