Status:
COMPLETED
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
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Malignant Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT01264380
Start Date
January 1 2011
End Date
May 1 2013
Last Update
November 2 2016
Active Locations (10)
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1
La Jolla, California, United States, 92037
2
Los Angeles, California, United States, 90095-1752
3
San Francisco, California, United States, 94115-1705
4
Aurora, Colorado, United States, 80045