A Study of DCC-2701 in Participants With Advanced Solid Tumors

Phase 1TerminatedNCT02228811

Deciphera Pharmaceuticals, LLC44 enrolled

Overview

The main purpose of this study is to investigate the safety of the investigational drug DCC-2701 and whether it will work to help people who have advanced solid tumors or cancer that has spread to other parts of the body.

This is a first-in-human study of DCC-2701. The primary purpose of this study is to determine what dose of DCC-2701, can be given safely to patients with advanced solid tumors. The study will have two phases. The first phase will assess escalating doses of DCC-2701 in order to determine the maximally tolerated dose (MTD) and the optimal dosing regimen (ODR) of DCC-2701. Once the MTD and ODR is established, a dose expansion phase will further evaluate the safety of DCC-2701, as well as the activity of DCC-2701 in select solid tumor types.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Locally Advanced Tumors Metastatic Solid Tumors Cancers With MET Genomic Alterations Cancers With TRK Genomic Alterations

Interventions

DCC-2701 tabletDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Advanced or metastatic solid tumor that has progressed or was not responsive to standard therapy * The cancer has no proven effective therapy * The cancer can be biopsied (depending on the tumor type and/or the dose of drug received, tumor biopsies may be required) * Able to swallow tablets Exclusion Criteria: * Have active central nervous system (CNS) metastasis * Have an active infection of any kind (fungal, viral, or bacterial) * Are pregnant or breastfeeding

Locations (5)

University of Colorado Hospital

Aurora, Colorado, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

The Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Outcomes

Primary Outcomes

Maximum Tolerated Dose (MTD) of DCC-2701

Time frame: 28 days (1 cycle)

Secondary Outcomes

Pharmacokinetics (PK): Maximum Concentration (Cmax) of DCC-2701

Time frame: Cycle 1: Predose and up to 24 hours postdose (Cycle = 28 Days)

Pharmacokinetics (PK): Time to Maximum Concentration (Tmax) of DCC-2701

Time frame: Cycle 1: Predose and up to 24 hours postdose (Cycle = 28 Days)

Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of DCC-2701

Time frame: Cycle 1: Predose and up to 24 hours postdose (Cycle = 28 Days)

Number of Participants with Tumor Response according to Response Evaluations Criteria in Solid Tumors (RECIST) version 1.1

Time frame: Baseline through study completion (estimated as 18 months)

Data from ClinicalTrials.gov

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