A Study of Vemurafenib in Patients With BRAF V600 Mutation-Positive Cancers
This study is currently recruiting participants.
Verified May 2013 by Hoffmann-La Roche
Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01524978
First received: January 27, 2012
Last updated: May 7, 2013
Last verified: May 2013
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Purpose
This open-label, multi-center study will assess the efficacy and safety of vemurafenib in patients with BRAF V600 mutation-positive cancers (solid tumors and multiple myeloma, except melanoma and papillary thyroid cancer) and for whom vemurafenib is deemed the best treatment option in the opinion of the investigator. Patients will receive twice daily oral doses of 960 mg vemurafenib until disease progression, unacceptable toxicity, or withdrawal of consent.
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Myeloma, Neoplasms |
Drug: Vemurafenib |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open-label, Phase II Study of Vemurafenib in Patients With BRAF V600 Mutation-positive Cancers |
Resource links provided by NLM:
Further study details as provided by Hoffmann-La Roche:
Primary Outcome Measures:
- Tumor Response Rate [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Safety: Incidence of adverse events [ Time Frame: Approximately 3 years ] [ Designated as safety issue: No ]
- Overall Response Rate (ORR) [ Time Frame: Approximately 3 years ] [ Designated as safety issue: No ]
- Tumor Response Rate [ Time Frame: Approximately 3 years ] [ Designated as safety issue: No ]
- Duration of Response (DOR) [ Time Frame: Approximately 3 years ] [ Designated as safety issue: No ]
- Time to Response [ Time Frame: Approximately 3 years ] [ Designated as safety issue: No ]
- Time to Tumor Progression (TTP) [ Time Frame: Approximately 3 years ] [ Designated as safety issue: No ]
- Progression free Survival (PFS) [ Time Frame: Approximately 3 years ] [ Designated as safety issue: No ]
- Overall Survival (OS) [ Time Frame: Approximately 3 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 101 |
| Study Start Date: | April 2012 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | December 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Single Arm |
Drug: Vemurafenib
Vemurafenib 960 mg twice a day until disease progression, unacceptable toxicity, or withdrawal of consent
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01524978
Show 31 Study Locations
Contacts
| Contact: Please reference Study ID Number: MO28072 www.roche.com/about_roche/roche_worldwide.htm | 888-662-6728 (U.S. Only) | genentechclinicaltrials@druginfo.com |
Show 31 Study LocationsSponsors and Collaborators
Hoffmann-La Roche
Investigators
| Study Director: | Clinical Trials | Hoffmann-La Roche |
More Information
Additional Information:
No publications provided
| Responsible Party: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT01524978 History of Changes |
| Other Study ID Numbers: | MO28072 |
| Study First Received: | January 27, 2012 |
| Last Updated: | May 7, 2013 |
| 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 May 19, 2013