Clinical trial NCT01804140: A Screening Study to Detect BRAF V600 Mutation-Positive Patients For Enrollment Into Clinical Research Studies of Zelboraf (Vemurafenib)
Official title: Screening Protocol to Detect BRAF V600 Mutation-Positive Patients for Enrollment Into Clinical Research Studies of Vemurafenib
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Myeloma, Neoplasms
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2013-03-05
Enrollment: 662
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with solid tumors (other than metastatic melanoma or papillary thyroid cancer) or multiple myeloma

Brief 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

Primary outcomes:
measure: Percentage of Participants With BRAF V600 Mutation Positivity in Tumor Samples by Cancer Type
timeFrame: Up to 1 year
measure: Number of Participants Classified Based on Different Types of BRAF V600 Mutation Patterns in Tumor Samples
timeFrame: Up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Sedona
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Burbank
country: United States
state: California
city: Rancho Cucamonga
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Ocala
country: United States
state: Florida
city: Woodbury
country: United States
state: Minnesota
city: Columbia
country: United States
state: Missouri
city: Las Vegas
country: United States
state: Nevada
city: Nashville
country: United States
state: Tennessee
city: Amarillo
country: United States
state: Texas
city: Austin
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Denton
country: United States
state: Texas
city: McAllen
country: United States
state: Texas
city: Tyler
country: United States
state: Texas
city: Spokane
country: United States
state: Washington
city: Yakima
country: United States
state: Washington
Study officials:
affiliation: Genentech, Inc.
name: Clinical Trials
role: STUDY_DIRECTOR
References: