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

NCT01107418 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2015-08-26

Study results available
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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

  • Malignant Melanoma

Interventions

DRUG

RO5185426

dosage b) orally twice daily, days 1-15 (morning dose)

DRUG

RO5185426

dosage c) orally twice daily, days 1-15 (morning dose)

DRUG

RO5185426

dosage d) orally twice daily, days 1-15 (morning dose)

DRUG

RO5185426

960 mg orally twice daily, from day 22 onward

DRUG

RO5185426

dosage a) orally twice daily, days 1-15 (morning dose)

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2013-02-28
Completion
2013-02-28

Countries

  • United States
  • Australia

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01107418 on ClinicalTrials.gov