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

Metastatic Solid Tumors Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02228811
• Other study ID #: DCC-2701-01-001
• Status: Terminated
• Phase: Phase 1
• First received: August 27, 2014
• Last updated: January 30, 2018
• Start date: June 2014
• Est. completion date: January 2018

Study information

• Verified date: December 2016
• Source: Deciphera Pharmaceuticals LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 44
• Est. completion date: January 2018
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancers With MET Genomic Alterations
• Cancers With TRK Genomic Alterations
• Locally Advanced Tumors
• Metastatic Solid Tumors
• Neoplasms

Intervention

Drug:
• DCC-2701 tablet

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Deciphera Pharmaceuticals LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Tolerated Dose (MTD) of DCC-2701		28 days (1 cycle)
Secondary	Pharmacokinetics (PK): Maximum Concentration (Cmax) of DCC-2701		Cycle 1: Predose and up to 24 hours postdose (Cycle = 28 Days)
Secondary	Pharmacokinetics (PK): Time to Maximum Concentration (Tmax) of DCC-2701		Cycle 1: Predose and up to 24 hours postdose (Cycle = 28 Days)
Secondary	Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of DCC-2701		Cycle 1: Predose and up to 24 hours postdose (Cycle = 28 Days)
Secondary	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)