A Study of DCC-2701 in Participants With Advanced Solid Tumors
A Multicenter Phase 1 Ascending Dose Study of DCC-2701 To Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics in Patients With Advanced Solid Tumors
1 other identifier
interventional
44
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jun 2014
Typical duration for phase_1
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2014
CompletedFirst Submitted
Initial submission to the registry
August 27, 2014
CompletedFirst Posted
Study publicly available on registry
August 29, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2018
CompletedFebruary 1, 2018
December 1, 2016
3.4 years
August 27, 2014
January 30, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Maximum Tolerated Dose (MTD) of DCC-2701
28 days (1 cycle)
Secondary Outcomes (4)
Pharmacokinetics (PK): Maximum Concentration (Cmax) of DCC-2701
Cycle 1: Predose and up to 24 hours postdose (Cycle = 28 Days)
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)
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)
Study Arms (1)
DCC-2701 tablet
EXPERIMENTALDCC-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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Have active central nervous system (CNS) metastasis
- Have an active infection of any kind (fungal, viral, or bacterial)
- Are pregnant or breastfeeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
University of Colorado Hospital
Aurora, Colorado, 80045, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
The Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Oliver Rosen, M.D.
Deciphera Pharmaceuticals, LLC
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 27, 2014
First Posted
August 29, 2014
Study Start
June 1, 2014
Primary Completion
November 1, 2017
Study Completion
January 1, 2018
Last Updated
February 1, 2018
Record last verified: 2016-12