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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01524978
First received: January 27, 2012
Last updated: September 1, 2016
Last verified: September 2016

January 27, 2012
September 1, 2016
April 2012
September 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 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.

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]
Hyman DM, Puzanov I, Subbiah V, Faris JE, Chau I, Blay JY, Wolf J, Raje NS, Diamond EL, Hollebecque A, Gervais R, Elez-Fernandez ME, Italiano A, Hofheinz RD, Hidalgo M, Chan E, Schuler M, Lasserre SF, Makrutzki M, Sirzen F, Veronese ML, Tabernero J, Baselga J. Vemurafenib in Multiple Nonmelanoma Cancers with BRAF V600 Mutations. N Engl J Med. 2015 Aug 20;373(8):726-36. doi: 10.1056/NEJMoa1502309.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
208
September 2016
September 2016   (final data collection date for primary outcome measure)

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
Both
16 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   China,   France,   Germany,   Spain,   United Kingdom
 
NCT01524978
MO28072
Not Provided
Not Provided
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
September 2016

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