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NCT01877811 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study, sponsored by Hoffmann-La Roche.

Completed
Registry status
Phase 1
Development phase
143
Enrollment target

NCT01877811 is a Phase 1 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 143 participants.

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The verdict

NCT01877811, a Phase 1 study, has completed, sponsored by Hoffmann-La Roche.

COMPLETED
Registry status
Phase 1
Development phase
143 participants
Enrollment target

Study Summary

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.

Interventions

  • DRUG RXDX-105

Trial Details

FieldValue
Enrollment Target 143 participants
Start Date 2013-06
Est. Completion 2019-02
Phase Phase 1

Sponsor

Hoffmann-La Roche

909 total trials

What the Registry Record Tells You About NCT01877811

The ClinicalTrials.gov registry entry for NCT01877811 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 143 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which RXDX-105 is the first listed.

NCT01877811 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01877811 about?

NCT01877811 is a clinical study titled "Study of RXDX-105, Potent RET Inhibitor in Patients With Advanced Lung Cancer and Other Solid Tumors". 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 dos...

What is the current status of trial NCT01877811?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 143 participants. The study started on 2013-06. Estimated completion is 2019-02.

What interventions are being tested in trial NCT01877811?

The interventions under investigation include: RXDX-105 (DRUG).

Who is sponsoring clinical trial NCT01877811?

This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.