NCT02571036

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

A Multicenter Phase 1, Open-Label Study of DCC-2618 to Assess Safety, Tolerability, Efficacy, and Pharmacokinetics in Patients With Advanced Malignancies

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 282 (actual)
• Sponsor: Deciphera Pharmaceuticals, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Gastrointestinal Stromal Tumors
• Advanced Systemic Mastocytosis
• Advanced Cancers

Interventions

Type	Name	Description
DRUG	DCC-2618	50 mg formulated tablets
DRUG	DCC-2618	10 mg and 50 mg formulated tablets

Timeline

• Start date: 2015-11-01
• Primary completion: 2022-04-29
• Completion: 2022-04-29
• First posted: 2015-10-08
• Last updated: 2023-12-13

Locations

26 sites across 6 countries: United States, Canada, Germany, Italy, Netherlands, United Kingdom

Regulatory

• FDA-regulated drug study