Clinical trial NCT02228811: A Study of DCC-2701 in Participants With Advanced Solid Tumors
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Locally Advanced Tumors
Metastatic Solid Tumors
Cancers With MET Genomic Alterations
Cancers With TRK Genomic Alterations
Lead sponsor: Deciphera Pharmaceuticals, LLC
Sponsor class: INDUSTRY
First posted: 2014-08-29
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Maximum Tolerated Dose (MTD) of DCC-2701
timeFrame: 28 days (1 cycle)
Secondary outcomes:
measure: Pharmacokinetics (PK): Maximum Concentration (Cmax) of DCC-2701
timeFrame: Cycle 1: Predose and up to 24 hours postdose (Cycle = 28 Days)
measure: Pharmacokinetics (PK): Time to Maximum Concentration (Tmax) of DCC-2701
timeFrame: Cycle 1: Predose and up to 24 hours postdose (Cycle = 28 Days)
measure: Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of DCC-2701
timeFrame: Cycle 1: Predose and up to 24 hours postdose (Cycle = 28 Days)
measure: Number of Participants with Tumor Response according to Response Evaluations Criteria in Solid Tumors (RECIST) version 1.1
timeFrame: Baseline through study completion (estimated as 18 months)
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Philadelphia
country: United States
facility: The Hospital of the University of Pennsylvania
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: Deciphera Pharmaceuticals, LLC
name: Oliver Rosen, M.D.
role: STUDY_DIRECTOR
References: