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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01804140
First received: February 26, 2013
Last updated: August 4, 2014
Last verified: August 2014
  Purpose

This is a screening study to detect BRAF V600 mutation-positive patients for enr ollment into clinical research studies of Zelboraf (vemurafenib). Tumor samples will be collected and analyzed from eligible patients with solid tumors (other t han metastatic melanoma or papillary thyroid cancer) or multiple myeloma. All in stitutions with identified patients as defined by this screening protocol will h ave potential access to the separate vemurafenib protocol MO28072.


Condition
Multiple Myeloma, Neoplasms

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Screening Protocol to Detect BRAF V600 Mutation-Positive Patients for Enrollment Into Clinical Research Studies of Vemurafenib

Resource links provided by NLM:


Further study details as provided by Genentech:

Primary Outcome Measures:
  • Incidence of BRAF V600 mutation positivity in tumor samples [ Time Frame: approximately 12 months ] [ Designated as safety issue: No ]
  • Description of BRAF V600 mutation patterns in tumor samples [ Time Frame: approximately 12 months ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   None Retained

Formalin-fixed paraffin-embedded (FFPE) tumor samples


Enrollment: 658
Study Start Date: December 2012
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with solid tumors (other than metastatic melanoma or papillary thyroid cancer) or multiple myeloma

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01804140

Locations
United States, Arizona
Sedona, Arizona, United States, 86336
Tucson, Arizona, United States, 85704
United States, California
Burbank, California, United States, 91505
Rancho Cucamonga, California, United States, 91730
United States, Colorado
Denver, Colorado, United States, 80218
United States, Florida
Ocala, Florida, United States, 34471
United States, Minnesota
Woodbury, Minnesota, United States, 55125
United States, Missouri
Columbia, Missouri, United States, 65201
United States, Nevada
Las Vegas, Nevada, United States, 89169
United States, Tennessee
Nashville, Tennessee, United States, 37232
United States, Texas
Amarillo, Texas, United States, 79106
Austin, Texas, United States, 78705
Dallas, Texas, United States, 75237
Dallas, Texas, United States, 75231
Dallas, Texas, United States, 75246
Denton, Texas, United States, 76210
McAllen, Texas, United States, 78503
Tyler, Texas, United States, 75702
United States, Washington
Spokane, Washington, United States, 99204
Yakima, Washington, United States, 98902
Sponsors and Collaborators
Genentech
Investigators
Study Director: Clinical Trials Genentech
  More Information

No publications provided

Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT01804140     History of Changes
Other Study ID Numbers: ML28560
Study First Received: February 26, 2013
Last Updated: August 4, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on August 28, 2014