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

January 30, 2018 updated by: Deciphera Pharmaceuticals LLC

A Multicenter Phase 1 Ascending Dose Study of DCC-2701 To Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics in Patients With Advanced Solid Tumors

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

44

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Hospital
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • The Hospital of the University of Pennsylvania
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center
    • Texas
      • Houston, Texas, United States, 77030
        • MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximum Tolerated Dose (MTD) of DCC-2701
Time Frame: 28 days (1 cycle)
28 days (1 cycle)

Secondary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetics (PK): Maximum Concentration (Cmax) of DCC-2701
Time Frame: Cycle 1: Predose and up to 24 hours postdose (Cycle = 28 Days)
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)
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)
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)
Baseline through study completion (estimated as 18 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Deciphera Pharmaceuticals LLC

Investigators

  • Study Director: Oliver Rosen, M.D., Deciphera Pharmaceuticals LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

November 1, 2017

Study Completion (Actual)

January 1, 2018

Study Registration Dates

First Submitted

August 27, 2014

First Submitted That Met QC Criteria

August 28, 2014

First Posted (Estimate)

August 29, 2014

Study Record Updates

Last Update Posted (Actual)

February 1, 2018

Last Update Submitted That Met QC Criteria

January 30, 2018

Last Verified

December 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DCC-2701-01-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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