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 20, 2014
Last verified: October 2014
  Purpose

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.


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel 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:
  • 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 ]

Estimated Enrollment: 160
Study Start Date: April 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 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

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
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01524978

Contacts
Contact: Reference Study ID Number: MO28072 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

  Show 34 Study Locations
Sponsors 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: October 20, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 29, 2014