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

Deciphera

Status and phase: Terminated; Phase 1

Conditions: Cancers With TRK Genomic Alterations; Cancers With MET Genomic Alterations; Metastatic Solid Tumors; Locally Advanced Tumors

Treatments: Drug: DCC-2701 tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT02228811

DCC-2701-01-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 44 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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44 participants in 1 patient group

DCC-2701 tablet

Experimental group

Description:

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.

Treatment:

Drug: DCC-2701 tablet