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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2018-01-31

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

DCC-2701 tablet

Intervention Type DRUG

Interventions

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DCC-2701 tablet

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No