Status:
COMPLETED
A Study of Vemurafenib in Participants With BRAF V600 Mutation-Positive Cancers
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Multiple Myeloma, Neoplasms
Eligibility:
All Genders
16+ years
Phase:
PHASE2
Brief Summary
This open-label, multi-center study will assess the efficacy and safety of vemurafenib in participants with BRAF V600 mutation-positive cancers (solid tumors and multiple myeloma, except melanoma and ...
Eligibility Criteria
Inclusion
- 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
- Must have received at least one prior systemic therapy for the treatment of multiple myeloma
- Treated with local radiotherapy
- Must have relapsed and/or refractory multiple myeloma with measurable disease
Exclusion
- Melanoma, papillary thyroid cancer or hematological malignancies (with the exception of multiple myeloma)
- Uncontrolled concurrent malignancy
- Multiple myeloma: solitary bone or solitary extramedullary plasmacytoma as the only evidence of plasma cell dyscrasia
- Active or untreated central nervous system (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
Key Trial Info
Start Date :
April 12 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 28 2016
Estimated Enrollment :
208 Patients enrolled
Trial Details
Trial ID
NCT01524978
Start Date
April 12 2012
End Date
October 28 2016
Last Update
November 20 2017
Active Locations (34)
Enter a location and click search to find clinical trials sorted by distance.
1
Arizona Oncology
Tucson, Arizona, United States, 85704
2
Rocky Mountain Cancer Centers, LLP
Aurora, Colorado, United States, 80012
3
Massachusetts General Hospital;Oncology
Boston, Massachusetts, United States, 02114
4
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215