A Study of Zelboraf (Vemurafenib) in Patients With BRAF V600 Mutation-Positive Cancers
Conditions
Multiple Myeloma, Neoplasms
Conditions: official terms
Multiple Myeloma
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: cetuximab Type: Drug
Name: vemurafenib [Zelboraf] Type: Drug
Name: vemurafenib [Zelboraf] Type: Drug
Overall Status
Recruiting
Summary
This open-label, multi-center study will assess the efficacy and safety of Zelboraf (vemurafenib) in patients with BRAF V600 mutation-positive cancers (solid tumors and multiple myeloma, except melanoma and papillary thyroid cancer) and for whom Zelboraf is deemed the best treatment option in the opinion of the investigator. Patients will receive twice daily oral doses of 960 mg Zelboraf until disease progression, unacceptable toxicity, or withdrawal of consent.

The safety and efficacy of Zelboraf in combination with cetuximab in a subset of patients with colorectal cancer will also be assessed.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Adult patients, >/=18 years of age

- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

- Must have recovered from all side effects of their most recent systemic or local treatment

- Adequate hematological, renal and liver function

For solid tumors only:

- Histologically confirmed cancers (excluding melanoma and papillary thyroid cancer) with a BRAF V600 mutation and that are resistant to standard therapy or for which standard or curative therapy does not exist

- Measurable disease according to Response Evaluation Criteria In Solid Tumors (RECIST)

For multiple myeloma only:

- Confirmed diagnosis of multiple myeloma with a BRAF V600 mutation

- Patients must have received at least one prior systemic therapy for the treatment of multiple myeloma

- Patients treated with local radiotherapy

- Patients must have relapsed and/or refractory multiple myeloma with measurable disease

Exclusion Criteria:

- Melanoma, papillary thyroid cancer or hematological malignancies (with the exception of multiple myeloma)

- Uncontrolled concurrent malignancy

- For patients with multiple myeloma: solitary bone or solitary extramedullary plasmacytoma as the only evidence of plasma cell dyscrasia

- Active or untreated CNS metastases

- History of or known carcinomatous meningitis

- Concurrent administration of any anti-cancer therapies other than those administered in this study

- Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that would, in the investigator's opinion, contraindicate participation in this study
Locations
Tucson, Arizona, United States
Status: Completed
Denver, Colorado, United States
Status: Completed
Boston, Massachusetts, United States
Status: Active, not recruiting
Boston, Massachusetts, United States
Status: Completed
Boston, Massachusetts, United States
Status: Recruiting
Detroit, Michigan, United States
Status: Completed
St. Louis, Missouri, United States
Status: Recruiting
New York, New York, United States
Status: Recruiting
Nashville, Tennessee, United States
Status: Recruiting
Houston, Texas, United States
Status: Active, not recruiting
Yakima, Washington, United States
Status: Completed
Beijing, China
Status: Not yet recruiting
Tianjin, China
Status: Not yet recruiting
Bordeaux, France
Status: Recruiting
Caen, France
Status: Active, not recruiting
Dijon, France
Status: Recruiting
Lyon, France
Status: Active, not recruiting
Marseille Cedex 09, France
Status: Recruiting
Saint Herblain, France
Status: Recruiting
Toulouse, France
Status: Terminated
VILLEJUIF Cedex, France
Status: Active, not recruiting
Essen, Germany
Status: Active, not recruiting
Köln, Germany
Status: Active, not recruiting
Mannheim, Germany
Status: Recruiting
Oviedo, Asturias, Spain
Status: Recruiting
Barcelona, Spain
Status: Recruiting
Barcelona, Spain
Status: Recruiting
Madrid, Spain
Status: Recruiting
Madrid, Spain
Status: Recruiting
Madrid, Spain
Status: Active, not recruiting
Salamanca, Spain
Status: Recruiting
Valencia, Spain
Status: Recruiting
Aberdeen, United Kingdom
Status: Recruiting
London, United Kingdom
Status: Active, not recruiting
Sutton, United Kingdom
Status: Recruiting
Start Date
April 2012
Completion Date
April 2017
Sponsors
Hoffmann-La Roche
Source
Hoffmann-La Roche
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page