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

Genentech

Status: Completed

Conditions: Multiple Myeloma, Neoplasms

Study type: Observational

Funder types: Industry

Identifiers

NCT01804140

ML28560

Details and patient eligibility

About

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.

Enrollment: 662 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

662 participants in 1 patient group

Cohort