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

Phase 1

Terminated

• Conditions: Metastatic Solid Tumors; Cancers With MET Genomic Alterations; Cancers With TRK Genomic Alterations; Locally Advanced Tumors
• Interventions: Drug: DCC-2701 tablet

• Registration Number: NCT02228811
• Lead Sponsor: Deciphera Pharmaceuticals, LLC

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-08-27
• Study First Submitted QC: 2014-08-28
• Study First Posted: 2014-08-29
• Status Verified: 2016-12
• Primary Completion: 2017-11
• Study Completion: 2018-01
• Last Update Submitted: 2018-01-30
• Last Update Posted: 2018-02-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 44

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DCC-2701 tablet	DCC-2701 tablet	DCC-2701 tablets in escalating dose cohorts given orally BID (twice daily) every 12 hours for a 28-day cycle. Participants may continue to receive study drug until discontinuation criteria are met.

Primary Outcome Measures

Name	Time	Method
Maximum Tolerated Dose (MTD) of DCC-2701	28 days (1 cycle)

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK): Maximum Concentration (Cmax) of DCC-2701	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	Baseline through study completion (estimated as 18 months)
Pharmacokinetics (PK): Time to Maximum Concentration (Tmax) of DCC-2701	Cycle 1: Predose and up to 24 hours postdose (Cycle = 28 Days)
Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of DCC-2701	Cycle 1: Predose and up to 24 hours postdose (Cycle = 28 Days)

Trial Locations

Locations (5)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

The Hospital of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

University of Colorado Hospital; 🇺🇸 Aurora, Colorado, United States

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States