A Study of RO5185426 in Patients With Metastatic Melanoma

Completed · Phase 2

Conditions studied: Malignant Melanoma

In brief

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.

Key facts

Study ID

NCT01248936

Run by

Hoffmann-La Roche

People needed

374

Starts

2010-12-01

Expected to finish

2011-10-01

Last updated by the study team

2016-08-12

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Tucson, Arizona, United States
• Study site — Los Angeles, California, United States
• Study site — San Francisco, California, United States
• Study site — San Francisco, California, United States
• Study site — Santa Monica, California, United States
• Study site — Aurora, Colorado, United States
• Study site — New Haven, Connecticut, United States
• Study site — Palm Harbor, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Park Ridge, Illinois, United States
• Study site — Boston, Massachusetts, United States
• Study site — Boston, Massachusetts, United States
• Study site — Detroit, Michigan, United States
• Study site — St Louis, Missouri, United States
• Study site — New York, New York, United States
• Study site — New York, New York, United States
• Study site — New York, New York, United States
• Study site — New York, New York, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Oklahoma City, Oklahoma, United States
• Study site — Portland, Oregon, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Columbia, South Carolina, United States
• Study site — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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