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

NCT02228811 — Phase 1, Terminated, 44 participants, Deciphera Pharmaceuticals, LLC

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

Registry	NCT02228811
Status	Terminated
Phase	Phase 1
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	44 (Actual)
Sponsor	Deciphera Pharmaceuticals, LLC (Industry)
Conditions	Locally Advanced Tumors, Metastatic Solid Tumors, Cancers With MET Genomic Alterations, Cancers With TRK Genomic Alterations
Interventions	DCC-2701 tablet (Drug)
Dates	start 2014-06-01, primary completion 2017-11-01, completion 2018-01-01, first posted 2014-08-29, last updated 2018-02-01
Locations	5 sites in United States

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
DCC-2701 tablet	Experimental	Drug: 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.

DCC-2701 tablet (Drug)

+Outcome measures

Primary outcomes

Maximum Tolerated Dose (MTD) of DCC-2701 [28 days (1 cycle)]

Secondary outcomes

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)]

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (5)

Facility	City	Country
University of Colorado Hospital	Aurora, Colorado	United States
Massachusetts General Hospital	Boston, Massachusetts	United States
The Hospital of the University of Pennsylvania	Philadelphia, Pennsylvania	United States
Vanderbilt University Medical Center	Nashville, Tennessee	United States
MD Anderson Cancer Center	Houston, Texas	United States

+Investigators

Oliver Rosen, M.D., Study director, Deciphera Pharmaceuticals, LLC

My Notes

Public

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