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A Pharmacokinetic and Metabolism Study of 14C-labeled RO5185426 on Patients With Metastatic Melanoma

CompletedPhase 1

Sponsor: Hoffmann-La Roche

Conditions: Malignant Melanoma

Interventions: RO5185426

Countries: Switzerland

This open-label, non-randomized study will assess the mass balance, metabolism, routes and rates of elimination as well as efficacy and safety of RO5185426 (RG7204; PLEXXIKON; PLX4032) in previously treated or untreated patients with metastatic melanoma. Patients will receive continuous twice daily oral treatment with RO5185426. On Day 15, a 14C-labeled dose will be administered. Anticipated time on study treatment is until disease progression occurs.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Histologically confirmed metastatic melanoma, surgically incurable and unresectable Stage IIIc or IV (AJCC)
* Prior treatment for metastatic melanoma allowed; \>/= 28 days must be elapsed since previous systemic treatment prior to first administration of study drug
* Positive BRAF V600E mutation result (by Roche CoDx test)
* ECOG performance status 0-1
* Adequate hematologic, renal and liver function
* Body Mass Index (BMI) 18 to 32 kg/m2 inclusive

Exclusion Criteria:

* Active CNS lesions
* History of or known spinal cord compression, or carcinomatous meningitis
* Anticipated or ongoing administration of any anticancer therapies other than those administered in this study
* Refractory nausea or vomiting, or other medical conditions that are capable of altering the absorption, metabolism or elimination of the study drug
* Known clinically significant active infection
* Known HIV positivity or AIDS-related illness, active HBV, or active HCV
* 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
* Clinically significant cardiovascular disease or incident within the 6 months prior to study drug administration
* Patients who have had at least one dose of study drug (RO5185426 or comparator) in a clinical trial that includes RO5185426

Locations (1)

Zurich, Switzerland