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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02228811
Recruitment Status : Terminated
First Posted : August 29, 2014
Last Update Posted : February 1, 2018
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Locally Advanced Tumors Metastatic Solid Tumors Cancers With MET Genomic Alterations Cancers With TRK Genomic Alterations Drug: DCC-2701 tablet Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter Phase 1 Ascending Dose Study of DCC-2701 To Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics in Patients With Advanced Solid Tumors
Study Start Date : June 2014
Actual Primary Completion Date : November 2017
Actual Study Completion Date : January 2018

Arm Intervention/treatment
Experimental: 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.
Drug: DCC-2701 tablet

Primary Outcome Measures :
  1. Maximum Tolerated Dose (MTD) of DCC-2701 [ Time Frame: 28 days (1 cycle) ]

Secondary Outcome Measures :
  1. Pharmacokinetics (PK): Maximum Concentration (Cmax) of DCC-2701 [ Time Frame: Cycle 1: Predose and up to 24 hours postdose (Cycle = 28 Days) ]
  2. Pharmacokinetics (PK): Time to Maximum Concentration (Tmax) of DCC-2701 [ Time Frame: Cycle 1: Predose and up to 24 hours postdose (Cycle = 28 Days) ]
  3. 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) ]
  4. 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) ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02228811

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United States, Colorado
University of Colorado Hospital
Aurora, Colorado, United States, 80045
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Pennsylvania
The Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Deciphera Pharmaceuticals LLC
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Study Director: Oliver Rosen, M.D. Deciphera Pharmaceuticals LLC

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Responsible Party: Deciphera Pharmaceuticals LLC Identifier: NCT02228811    
Other Study ID Numbers: DCC-2701-01-001
First Posted: August 29, 2014    Key Record Dates
Last Update Posted: February 1, 2018
Last Verified: December 2016
Additional relevant MeSH terms:
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