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 eventsBest 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
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