Status:
COMPLETED
A Study of RO5185426 in Patients With Metastatic Melanoma
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Malignant Melanoma
Eligibility:
All Genders
16+ years
Phase:
PHASE2
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
374 Patients enrolled
Trial Details
Trial ID
NCT01248936
Start Date
December 1 2010
End Date
October 1 2011
Last Update
August 12 2016
Active Locations (28)
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1
Tucson, Arizona, United States, 85724-5078
2
Los Angeles, California, United States, 90095
3
San Francisco, California, United States, 94115
4
San Francisco, California, United States, 94117