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
| Status: | Completed |
|---|---|
| Conditions: | Skin Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | January 2011 |
| End Date: | May 2013 |
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
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.
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.
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
We found this trial at
10
sites
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