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A Study of the Effect of Food on the Pharmacokinetics of Single Dose RO5185426 And the Safety And Efficacy of Continuous Administration in Patients With BRAF V600E Mutation-Positive Metastatic Melanoma

Information source: Hoffmann-La Roche
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Malignant Melanoma

Intervention: RO5185426 (Drug); RO5185426 (Drug); RO5185426 (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Hoffmann-La Roche

Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche

Summary

This randomized, open-label, two period crossover study will evaluate the effect of food on the pharmacokinetics of a single dose of RO5185426 and the efficacy and safety of continuous administration in patients with BRAF V600E mutation-positive metastatic melanoma. Patients will be randomized to receive in a crossover design single oral doses of RO5185426 with or without food, with a 10-day washout period between doses. Following the crossover periods, patients will receive RO5185426 orally twice daily on a continuous basis until disease progression or unacceptable toxicity occurs.

Clinical Details

Official title: A Phase I, Randomized, Open-label, Multi-center, Two Period Crossover Study to Investigate the Effect of Food on the Pharmacokinetics of a Single Oral Dose of RO5185426, Followed by Administration of 960 mg RO5185426 Twice Daily to BRAF V600E Positive Metastatic Melanoma Patients

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Effect of food (high fat meal) on the pharmacokinetics of vemurafenib: AUC, C max, C min, T max, t1/2, k el

Secondary outcome:

Safety: Incidence of adverse events

Best Overall Response Rate, tumour assessments according to RECIST criteria

Overall survival

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Adult patients, >/= 18 years of age

- Histologically confirmed metastatic melanoma (Stage IV, American Joint Committee on

Cancer)

- Positive BRAF V600E mutation result determined by Cobas 4800 BRAF V600 Mutation Test

- Previously treated patients must have failed at least one prior treatment regimen; if

patients have received prior systemic treatments for metastatic melanoma, the time elapsed from previous therapy must be >/= 28 days; patients must have recovered fully from toxicities of all prior therapy

- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

- Evaluable disease (measurable for disease progression according to RECIST criteria)

- Adequate hematological, renal and liver function

Exclusion Criteria:

- Active CNS lesions

- History of or known spinal cord compression or carcinomatous meningitis

- Anticipated or ongoing administration of anti-cancer therapies other than those

administered in this study

- Previous malignancy within the past 5 years except for basal or squamous cell

carcinoma of the skin, melanoma in-situ and carcinoma in-situ of the cervix

- Previous treatment with BRAF inhibitor (sorafenib allowed) or MEK inhibitor

- Refractory nausea or vomiting, malabsorption, external biliary shunt, or history of

any type of gastrointestinal surgery that would preclude adequate absorption of study drug

Locations and Contacts

La Jolla, California 92037, United States

Los Angeles, California 90095-1752, United States

San Francisco, California 94115-1705, United States

Aurora, Colorado 80045, United States

Indianapolis, Indiana 46202, United States

Iowa City, Iowa 52242, United States

Lebanon, New Hampshire 03756, United States

Charleston, South Carolina 29425, United States

Nashville, Tennessee 37232, United States

Dallas, Texas 75246, United States

Additional Information

Starting date: January 2011
Last updated: May 5, 2015

Page last updated: August 20, 2015

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