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

NCT02571036 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 282

Last updated 2023-12-13

No results posted yet for this study

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

Interventions

DRUG

DCC-2618

50 mg formulated tablets

DRUG

DCC-2618

10 mg and 50 mg formulated tablets

Sponsors & Collaborators

  • Deciphera Pharmaceuticals, LLC

    lead INDUSTRY

Principal Investigators

  • Deciphera Pharmaceuticals, LLC · Deciphera Pharmaceuticals, LLC

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2022-04-29
Completion
2022-04-29
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Germany
  • Italy
  • Netherlands
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02571036 on ClinicalTrials.gov