Overview

A Study of RO5185426 in Patients With Metastatic Melanoma

Status:
Completed
Trial end date:
2011-10-01
Target enrollment:
0
Participant gender:
All
Summary
This is an open-label, non-comparative, multicenter, expanded access study of RO5185426 in patients who have received prior systemic therapy for metastatic melanoma and who have no other satisfactory treatment options.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Hoffmann-La Roche
Criteria
Inclusion Criteria:

- Histologically confirmed metastatic melanoma with documented BRAF V600E mutation,
determined by the cobas BRAF V600 mutation test

- Patients with either measurable or non-measurable disease

- Adequate recovery from most recent systemic or local treatment for metastatic melanoma

- Adequate organ function

- For women of childbearing potential, agreement to the use of two acceptable methods of
contraception, including one barrier method, during the study and for 6 months after
discontinuation of RO5185426

- For men with female partners of childbearing potential, agreement to use a latex
condom, and to advise their female partner to use an additional method of
contraception during the study and for 6 months after discontinuation of RO5185426

- Negative serum or urine pregnancy test within 7 days of commencement of treatment in
premenopausal women. Women who are either surgically sterile or have been
post-menopausal for at least 1 year are eligible to participate in this study

- Agreement not to donate blood or blood products during the study and for at least 6
months after discontinuation of RO5185426; for male patients, agreement not to donate
sperm during the study and for at least 6 months after discontinuation of RO5185426

Exclusion Criteria:

- Pregnant or breast-feeding

- Concurrent anti-tumor therapy

- Uncontrolled medical illness

- History of congenital prolonged QT syndrome or patients with a mean QTc interval
greater than 470 milliseconds at baseline, or ongoing grade 2 or greater cardiac
arrhythmia