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NCT02639546 · ClinicalTrials.gov registry record · Phase 1

Safety and Pharmacokinetics of Cobimetinib in Pediatric and Young Adult Participants With Previously Treated Solid Tumors

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

Completed
Registry status
Phase 1
Development phase
56
Enrollment target

NCT02639546 is a Phase 1 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 56 participants.

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The verdict

NCT02639546, a Phase 1 study, has completed, sponsored by Hoffmann-La Roche.

COMPLETED
Registry status
Phase 1
Development phase
56 participants
Enrollment target

Study Summary

This open-label, dose-escalation study is designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of cobimetinib in pediatric and young adult participants with solid tumors with known or potential kinase pathway activation for which standard therapy has proven to be ineffective or intolerable or for which no curative standard-of-care treatment options exist. The study will be conducted in two stages: a dose-escalation stage and an expansion stage at the recommended dose.

Interventions

  • DRUG Cobimetinib

Trial Details

FieldValue
Enrollment Target 56 participants
Start Date 2016-05-20
Est. Completion 2021-07-21
Phase Phase 1

Sponsor

Hoffmann-La Roche

909 total trials

What the Registry Record Tells You About NCT02639546

The ClinicalTrials.gov registry entry for NCT02639546 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 56 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 Cobimetinib is the first listed.

NCT02639546 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02639546 about?

NCT02639546 is a clinical study titled "Safety and Pharmacokinetics of Cobimetinib in Pediatric and Young Adult Participants With Previously Treated Solid Tumors". This open-label, dose-escalation study is designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of cobimetinib in pediatric and young adult participants with solid tumors with known or potential kinase pathway activation for which standard therapy has proven to be...

What is the current status of trial NCT02639546?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 56 participants. The study started on 2016-05-20. Estimated completion is 2021-07-21.

What interventions are being tested in trial NCT02639546?

The interventions under investigation include: Cobimetinib (DRUG).

Who is sponsoring clinical trial NCT02639546?

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.