N/A N=662

A Screening Study to Detect BRAF V600 Mutation-Positive Patients For Enrollment Into Clinical Research Studies of Zelboraf (Vemurafenib)

Multiple Myeloma, Neoplasms

Bottom Line

View on ClinicalTrials.gov: NCT01804140 ↗

Enrolled (actual)

662

Serious AEs

0.0%

Results posted

Jul 2015

Primary outcome: Primary: Percentage of Participants With BRAF V600 Mutation Positivity in Tumor Samples by Cancer Type — 0; 3; 11; 0 percentage of participants

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: —
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Genentech, Inc.
Primary completion: Sep 2013

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	—

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.

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

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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.