Phase 2
Completed N=24
A Study of RO5185426 in Previously Treated Melanoma Patients With Brain Metastases
Source: ClinicalTrials.gov NCT01253564 ↗Enrolled (actual)
24
Serious AEs
58.3%
Results posted
Aug 2015
Primary outcomePrimary: Percentage of Participants With Adverse Events (AEs) — 96; 83; 92; 17 percentage of participants
Summary
This open-label study will assess the safety and efficacy of RO5185426 in previously treated metastatic melanoma patients with brain metastases. Patients will receive RO5185426 at a dose of 960 mg twice daily orally until disease progression or unacceptable toxicity occurs.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Adverse Events (AEs) |
96; 83; 92; 17; 4; 58 | — |
| SECONDARY Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR) by Disease Site |
15.8; 61.9; 41.7 | — |
| SECONDARY Duration of Response by Disease Site |
4.4; 3.8; 3.7 | — |
| SECONDARY Time to Response by Disease Site |
NA; 1.4; 5.5 | — |
| SECONDARY Duration of Stable Disease (SD) by Disease Site |
5.5; 3.9; 3.9 | — |
| SECONDARY Time to New Lesion by Disease Site |
5.6; NA; 5.6 | — |
| SECONDARY Percentage of Participants With Disease Progression or Death by Disease Site |
100; 83.3; 100 | — |
| SECONDARY Progression Free Survival (PFS) |
4.3; 4.6; 3.9 | — |
| SECONDARY Percentage of Participants Who Died |
79.2 | — |
| SECONDARY Overall Survival (OS) |
5.3 | — |
| SECONDARY Percentage of Participants With Improvement in Total Daily Dose of Corticosteroids |
66.7 | — |
| SECONDARY Percentage of Participants With Improvement in Total Daily Dose of Narcotic Pain Analgesic |
8.3 | — |
| SECONDARY Percentage of Participants With Improvement in Visual Analog Scale (VAS) Assessment of Pain |
25.0; 20.8; 26.1; 13.0; 20.0; 20.0 | — |
| SECONDARY Percentage of Participants With Improvement in Physician's Assessment of Global Performance Status |
83.3 | — |
Eligibility Criteria
Inclusion Criteria
- Adult patients, >/= 18 years of age
- Metastatic melanoma (Stage IV, American Joint Committee on Cancer) with BRAF mutation (cobas 4800 BRAF V600 Mutation Test)
- Brain metastases for which surgical resection is not a treatment option
- Patients must have failed at least one previous treatment for brain metastases
- Requiring corticosteroids for symptom control
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Exclusion Criteria
- Increasing corticosteroid dose during the 7 days prior to study entry
- Previous malignancy within the past 2 years, except for basal or squamous cell carcinoma of the skin or carcinoma in-situ of the cervix
- Concurrent administration of any anticancer therapies other than those administered in the study
- Clinically significant cardiovascular disease or event within the 6 months prior to first dose of study drug
Data sourced from ClinicalTrials.gov (NCT01253564). 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.