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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: Completed Phase 1 study, sponsored by Hoffmann-La Roche.

NCT01877811 is a Phase 1 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 143 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (138% higher). According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

From signing of the informed consent up to approximately 12 months

Interventions

  • DRUG RXDX-105

Trial Details

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

909 total trials

What the finished NCT01877811 record still lists

NCT01877811 is an interventional study that assigns participants to a tested intervention. The registered 143 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (138% higher).

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

NCT01877811 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT01877811's enrollment target sits among peer trials

143 401st of 2000 higher than 1,600 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01877811, the US trial registry maintained by the National Library of Medicine. NCT01877811 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.