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Screening Protocol to Detect BRAF V600 Mutation-Positive Patients for Enrollment Into Clinical Research Studies of Vemurafenib


N/A
18 Years
N/A
Open (Enrolling)
Both
Multiple Myeloma, Neoplasms

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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