N/A
Completed N=662
A Screening Study to Detect BRAF V600 Mutation-Positive Patients For Enrollment Into Clinical Research Studies of Zelboraf (Vemurafenib)
Source: ClinicalTrials.gov NCT01804140 ↗Enrolled (actual)
662
Serious AEs
0.0%
Results posted
Jul 2015
Primary outcomePrimary: Percentage of Participants With BRAF V600 Mutation Positivity in Tumor Samples by Cancer Type — 0; 3; 11; 0 percentage of participants
Summary
This is a screening study to detect BRAF V600 mutation-positive patients for enrollment into clinical research studies of Zelboraf (vemurafenib). Tumor samples will be collected and analyzed from eligible patients with solid tumors (other than metastatic melanoma or papillary thyroid cancer) or multiple myeloma. All institutions with identified patients as defined by this screening protocol will have potential access to the separate vemurafenib protocol MO28072.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With BRAF V600 Mutation Positivity in Tumor Samples by Cancer Type |
0; 3; 11; 0; 0; 3 | — |
| PRIMARY Number of Participants Classified Based on Different Types of BRAF V600 Mutation Patterns in Tumor Samples |
16; 0; 0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Histologically confirmed solid tumors (excluding melanoma and papillary thyroid cancer) or multiple myeloma refractory to standard therapy or for which standard or curative therapy does not exist or is not considered appropriate by the investigator
- Patients with multiple myeloma must have received at least one line of prior systemic therapy for the treatment of multiple myeloma
Exclusion Criteria
- Eastern Cooperative Oncology Group (ECOG) performance status > 2
- Uncontrolled concurrent malignancy
- Active or untreated CNS metastases
- History of known carcinomatous meningitis
- Prior treatment with a BRAF or MEK inhibitor (prior sorafenib is allowed)
- Uncontrolled, severe medical illness or condition as defined in protocol MO28072
Data sourced from ClinicalTrials.gov (NCT01804140). 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.