A Study of Zelboraf (Vemurafenib) in Patients With BRAF V600 Mutation-Positive Cancers

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01524978
First received: January 27, 2012
Last updated: October 13, 2014
Last verified: October 2014

January 27, 2012
October 13, 2014
April 2012
December 2016   (final data collection date for primary outcome measure)
Tumor Response Rate [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01524978 on ClinicalTrials.gov Archive Site
  • Maximum tolerated dose for Zelboraf in combination with cetuximab [ Time Frame: Approximately 3 years ] [ Designated as safety issue: No ]
  • Dose-limiting toxicities of Zelboraf in combination with cetuximab [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • 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 ]
  • Clinical benefit 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 ]
  • 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 ]
Not Provided
Not Provided
 
A Study of Zelboraf (Vemurafenib) in Patients With BRAF V600 Mutation-Positive Cancers
An Open-label, Phase II Study of Vemurafenib in Patients With BRAF V600 Mutation-positive Cancers

This open-label, multi-center study will assess the efficacy and safety of Zelbo raf (vemurafenib) in patients with BRAF V600 mutation-positive cancers (solid tu mors and multiple myeloma, except melanoma and papillary thyroid cancer) and for whom Zelboraf is deemed the best treatment option in the opinion of the investi gator. Patients will receive twice daily oral doses of 960 mg Zelboraf until dis ease progression, unacceptable toxicity, or withdrawal of consent. The safety and efficacy of Zelboraf in combination with cetuximab in a subset of patients w ith colorectal cancer will also be assessed.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Multiple Myeloma, Neoplasms
  • Drug: cetuximab
    Escalating doses administered once weekly by intravenous infusion
  • Drug: vemurafenib [Zelboraf]
    Escalating doses given twice a day starting on Day 2
  • Drug: vemurafenib [Zelboraf]
    960 mg twice a day until disease progression, unacceptable toxicity, or withdrawal of consent
  • Experimental: Colorectal cancer patient subgroup
    Interventions:
    • Drug: cetuximab
    • Drug: vemurafenib [Zelboraf]
  • Experimental: Solid tumors & Multiple myeloma patients
    Intervention: Drug: vemurafenib [Zelboraf]
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
160
December 2016
December 2016   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Reference Study ID Number: MO28072 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com
United States,   China,   France,   Germany,   Spain,   United Kingdom
 
NCT01524978
MO28072
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP