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

NCT ID: NCT01804140

Last Updated: 2016-11-02

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

662 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-12-31

Study Completion Date

2013-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Multiple Myeloma, Neoplasms

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Genentech, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Genentech, Inc.

Locations

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Sedona, Arizona, United States

Site Status

Tucson, Arizona, United States

Site Status

Burbank, California, United States

Site Status

Rancho Cucamonga, California, United States

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Denver, Colorado, United States

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Ocala, Florida, United States

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Woodbury, Minnesota, United States

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Columbia, Missouri, United States

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Las Vegas, Nevada, United States

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Nashville, Tennessee, United States

Site Status

Amarillo, Texas, United States

Site Status

Austin, Texas, United States

Site Status

Dallas, Texas, United States

Site Status

Dallas, Texas, United States

Site Status

Dallas, Texas, United States

Site Status

Denton, Texas, United States

Site Status

McAllen, Texas, United States

Site Status

Tyler, Texas, United States

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Spokane, Washington, United States

Site Status

Yakima, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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ML28560

Identifier Type: -

Identifier Source: org_study_id