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Trial record 1 of 1 for:    NCT02228811
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A Study of DCC-2701 in Participants With Advanced Solid Tumors

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Deciphera Pharmaceuticals LLC
ClinicalTrials.gov Identifier:
NCT02228811
First received: August 27, 2014
Last updated: December 13, 2016
Last verified: December 2016
  Purpose
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 Intervention Phase
Locally Advanced Tumors
Metastatic Solid Tumors
Cancers With MET Genomic Alterations
Cancers With TRK Genomic Alterations
Drug: DCC-2701 tablet
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Further study details as provided by Deciphera Pharmaceuticals LLC:

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

Secondary Outcome Measures:
  • 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) ]

Estimated Enrollment: 105
Study Start Date: June 2014
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

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

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02228811

Locations
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
Investigators
Study Director: Oliver Rosen, M.D. Deciphera Pharmaceuticals LLC
  More Information

Responsible Party: Deciphera Pharmaceuticals LLC
ClinicalTrials.gov Identifier: NCT02228811     History of Changes
Other Study ID Numbers: DCC-2701-01-001
Study First Received: August 27, 2014
Last Updated: December 13, 2016

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on April 28, 2017