Phase 2
Completed N=374
A Study of RO5185426 in Patients With Metastatic Melanoma
Source: ClinicalTrials.gov NCT01248936 ↗Enrolled (actual)
374
Serious AEs
22.4%
Results posted
Feb 2016
Primary outcomePrimary: Number of Participants With Any Adverse Event, Adverse Events With Severity, Adverse Events Leading to Discontinuation — 346; 115; 15; 7 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Any Adverse Event, Adverse Events With Severity, Adverse Events Leading to Discontinuation |
346; 115; 15; 7; 9 | — |
| PRIMARY Number of Participants With Any Serious Adverse Event, Death and Cause of Death |
83; 43; 22; 8; 6; 2 | — |
| SECONDARY Number of Participants With Best Overall Response (Unconfirmed) |
129 | — |
| SECONDARY Number of Participants With Best Overall Response (Unconfirmed) by ECOG Performance |
13; 116 | — |
| SECONDARY Number of Participants With Best Overall Response (Confirmed) |
26 | — |
| SECONDARY Number of Participants With Best Overall Response (Confirmed) by ECOG Performance |
1; 25 | — |
| SECONDARY Mean Time to Complete Response/Partial Response |
1.8; 2.0 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01248936). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.