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NCT01107418 · ClinicalTrials.gov registry record · Phase 1

A Pharmacokinetic/Pharmacodynamic Study of RO5185426 in Previously Treated Patients With Metastatic Melanoma

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

Completed
Registry status
Phase 1
Development phase
52
Enrollment target
13
Study locations

NCT01107418 is a Phase 1 study of Malignant Melanoma that has completed, run by Hoffmann-La Roche. The registered enrollment target is 52 participants, below the 181-participant average among 28 other Malignant Melanoma trials with a reported enrollment target (71% lower). The trial reports 13 study locations across 10 states.

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The verdict

NCT01107418, a Phase 1 study of Malignant Melanoma, has completed, sponsored by Hoffmann-La Roche.

COMPLETED
Registry status
Phase 1
Development phase
52 participants
Enrollment target
13
Study locations

Study Summary

This open-label study will assess the pharmacokinetics, efficacy and safety of RO5185426 administered as 240mg tablets in previously treated patients with metastatic melanoma. Patients will be randomized to receive one of four dose-levels of RO5185426 \[RG7204; PLEXXIKON; PLX4032\] orally twice daily on days 1 to 15 (morning dose). Starting on day 22, treatment with RO5185426 may be resumed at a dose of 960 mg twice daily and continued until disease progression. Target sample size is \<100 patients.

Conditions Studied

Malignant Melanoma

Interventions

  • DRUG RO5185426

Study Locations (13)

California

  • - La Jolla
  • - San Francisco
  • - Stanford

Illinois

  • - Chicago
  • - Park Ridge

Connecticut

  • - New Haven

Iowa

  • - Sioux City

Nebraska

  • - Omaha

Ohio

  • - Columbus

Rhode Island

  • - East Providence

Virginia

  • - Charlottesville

Trial Details

FieldValue
Enrollment Target 52 participants
Start Date 2010-05
Est. Completion 2013-02
Phase Phase 1

Sponsor

Hoffmann-La Roche

909 total trials

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What the Registry Record Tells You About NCT01107418

The ClinicalTrials.gov registry entry for NCT01107418 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 52 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 181-participant average among 28 other Malignant Melanoma trials with a reported enrollment target (71% lower). The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Malignant Melanoma appearing as the primary indexed condition, and to 1 intervention - of which RO5185426 is the first listed.

NCT01107418 reports 13 study locations spanning 10 distinct geographic areas - top geographies include California, Illinois, Connecticut.

Frequently Asked Questions

What is clinical trial NCT01107418 about?

NCT01107418 is a clinical study titled "A Pharmacokinetic/Pharmacodynamic Study of RO5185426 in Previously Treated Patients With Metastatic Melanoma". This open-label study will assess the pharmacokinetics, efficacy and safety of RO5185426 administered as 240mg tablets in previously treated patients with metastatic melanoma. Patients will be randomized to receive one of four dose-levels of RO5185426 \[RG7204; PLEXXIKON; PLX4032\] orally twice dail...

What is the current status of trial NCT01107418?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 52 participants. The study started on 2010-05. Estimated completion is 2013-02.

What conditions does trial NCT01107418 study?

This clinical trial studies the following conditions: Malignant Melanoma.

What interventions are being tested in trial NCT01107418?

The interventions under investigation include: RO5185426 (DRUG).

Who is sponsoring clinical trial NCT01107418?

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

Where is trial NCT01107418 being conducted?

This trial has 13 study locations across California, Connecticut, Illinois, Iowa, Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.