Overview

This trial is active, not recruiting.

Condition multiple myeloma, neoplasms
Treatments cetuximab, vemurafenib [zelboraf]
Phase phase 2
Targets EGFR, BRAF
Sponsor Hoffmann-La Roche
Start date April 2012
End date September 2016
Trial size 208 participants
Trial identifier NCT01524978, MO28072

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.

United States Massachusetts
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
cetuximab
Escalating doses administered once weekly by intravenous infusion
vemurafenib [zelboraf]
Escalating doses given twice a day starting on Day 2
(Experimental)
vemurafenib [zelboraf]
960 mg twice a day until disease progression, unacceptable toxicity, or withdrawal of consent

Primary Outcomes

Measure
Tumor Response Rate
time frame: Week 8

Secondary Outcomes

Measure
Maximum tolerated dose for Zelboraf in combination with cetuximab
time frame: Approximately 3 years
Dose-limiting toxicities of Zelboraf in combination with cetuximab
time frame: 28 days
Safety: Incidence of adverse events
time frame: Approximately 3 years
Overall Response Rate (ORR)
time frame: Approximately 3 years
Clinical benefit rate
time frame: Approximately 3 years
Duration of Response (DOR)
time frame: Approximately 3 years
Time to Response
time frame: Approximately 3 years
Time to Tumor Progression (TTP)
time frame: Approximately 3 years
Progression free Survival (PFS)
time frame: Approximately 3 years
Overall Survival (OS)
time frame: Approximately 3 years

Eligibility Criteria

Male or female participants at least 16 years old.

Inclusion Criteria: - 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

Additional Information

Official title An Open-label, Phase II Study of Vemurafenib in Patients With BRAF V600 Mutation-positive Cancers
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Hoffmann-La Roche.
Location data was received from the National Cancer Institute and was last updated in September 2016.