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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:
ClinicalTrials.gov Identifier:
NCT01524978
First Posted: February 2, 2012
Last Update Posted: October 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
  Purpose

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.


Condition Intervention Phase
Multiple Myeloma, Neoplasms Drug: cetuximab Drug: vemurafenib [Zelboraf] Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 208
Study Start Date: April 2012
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Colorectal cancer patient subgroup Drug: cetuximab
Escalating doses administered once weekly by intravenous infusion
Drug: vemurafenib [Zelboraf]
Escalating doses given twice a day starting on Day 2
Experimental: Solid tumors & Multiple myeloma patients Drug: vemurafenib [Zelboraf]
960 mg twice a day until disease progression, unacceptable toxicity, or withdrawal of consent

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01524978


  Show 33 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01524978     History of Changes
Other Study ID Numbers: MO28072
First Submitted: January 27, 2012
First Posted: February 2, 2012
Last Update Posted: October 18, 2017
Last Verified: September 2016

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Cetuximab
Antineoplastic Agents