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Completed Phase 1 Interventional

Study of RXDX-105, Potent RET Inhibitor in Patients With Advanced Lung Cancer and Other Solid Tumors

ClinicalTrials.gov ID: NCT01877811

Public ClinicalTrials.gov record NCT01877811. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 6, 2026, 1:43 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

An Open-Label, Phase 1/1b, Single-Agent Study of RXDX-105 in Patients With Advanced Solid Tumors

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This is a first-in-human, multicenter, open-label study consisting of 2 phases. Phase 1 is a dose escalation study of RXDX-105 (formerly known as CEP-32496) in patients with advanced solid tumors aimed at defining the recommended Phase 2 dose (RP2D) and schedule for administration. Phase 1b is a dose expansion in approximately 90 patients with advanced solid tumors with specific histologies and/or molecular alterations of interest. Patients in Phase 1b will be treated at the RP2D determined in Phase 1.

Study identification

NCT ID
NCT01877811
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
Hoffmann-La Roche
Industry
Enrollment
143 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 31, 2013
Primary completion
Nov 30, 2018
Completion
Jan 31, 2019
Last update posted
Apr 24, 2019

2013 – 2019

United States locations

U.S. sites
14
U.S. states
11
U.S. cities
13
Facility City State ZIP Site status
City of Hope Duarte California
University of California Irvine College of Medicine Irvine California
University of California San Diego Moores Cancer Center San Diego California
Lombardi Comprehensive Cancer Center, Georgetown Washington D.C. District of Columbia
Florida Cancer Center Sarasota Florida
University Cancer & Blood Center, LLC Athens Georgia
Massachusetts General Hospital/Beth Israel Deaconess Med. Ctr./Dana Farber Cancer Institute Boston Massachusetts
Henry Ford Health System Detroit Michigan
Karmanos Cancer Center Detroit Michigan
Washington University St Louis Missouri
Memorial Sloan Kettering Cancer Center New York New York
Fox Chase Cancer Center Philadelphia Pennsylvania
University of Texas MD Anderson Cancer Center Houston Texas
University of Washington, Seattle Cancer Care Alliance Seattle Washington

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01877811, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 24, 2019 · Synced Sep 6, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01877811 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →