Screening Protocol to Detect BRAF V600 Mutation-Positive Patients for Enrollment Into Clinical Research Studies of Vemurafenib
N/A
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Multiple Myeloma, Neoplasms
Both
Multiple Myeloma, Neoplasms
Trial Information
Screening Protocol to Detect BRAF V600 Mutation-Positive Patients for Enrollment Into Clinical Research Studies of Vemurafenib
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
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
Incidence of BRAF V600 mutation positivity in tumor samples
Outcome Time Frame:
approximately 12 months
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Genentech
Authority:
United States: Food and Drug Administration
Study ID:
ML28560
NCT ID:
NCT01804140
Start Date:
December 2012
Completion Date:
August 2015
Related Keywords:
- Multiple Myeloma
- Neoplasms
- Neoplasms
- Multiple Myeloma
- Neoplasms, Plasma Cell
Name | Location |
|---|---|
| Alexandria, Minnesota 56308 | |
| Phoenix, Arizona 85012 | |
| Fountain Valley, California 92708 | |
| Miami, Florida 33176 | |
| Columbia, Missouri 65203 | |
| Nashville, Tennessee 37203-1632 | |
| Austin, Texas 78705 | |
| Seattle, Washington 98195 | |
| Denver, Colorado | |
| Las Vegas, Nevada 89109 |
