Roche trials database

Trial information

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

Status:

Recruiting

Protocol number:

MO28072

Sponsor:

Hoffmann-La Roche

Company division:

Pharmaceutical

Official Scientific Title:

An open-label, phase II study of vemurafenib in patients with BRAF V600 mutation-positive cancers

Brief summary:

This open-label, multi-center study will assess the efficacy and safety of vemurafenib in patients with BRAF V600 mutation-positive cancers (solid tumors and multiple myeloma, except melanoma and papillary thyroid cancer) and for whom vemurafenib is deemed the best treatment option in the opinion of the investigator. Patients will receive twice daily oral doses of 960 mg vemurafenib until disease progression, unacceptable toxicity, or withdrawal of consent. Target sample size is 101.

Study phase:

II

Study type:

Interventional; Treatment; Non-randomized; Open label; Single group; Safety/efficacy study

Conditions:

• Neoplasms
• Multiple Myeloma

Primary outcome:

1. Tumor Response Rate Time frame: Week 8

Key secondary outcomes:

1. Safety: Incidence of adverse events Time frame: Approximately 3 years
2. Overall Response Rate (ORR) Time frame: Approximately 3 years
3. Tumor Response Rate Time frame: Approximately 3 years
4. Duration of Response (DOR) Time frame: Approximately 3 years
5. Time to Response Time frame: Approximately 3 years
6. Time to Tumor Progression (TTP) Time frame: Approximately 3 years
7. Progression free Survival (PFS) Time frame: Approximately 3 years
8. Overall Survival (OS) Time frame: Approximately 3 years

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
• 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

Gender:

Males or Females

Age limits:

Min: 18 years Max: N/A (No limit)

Accepts healthy volunteers:

No

Anticipated start date:

April, 2012

Trial registration date:

18.01.2012

Date last updated:

10.06.2013

This trial is being conducted at the following locations:

France

• CAEN
• LYON

FRANCE

• BORDEAUX
• Dijon
• Marseille
• Saint Herblain
• Toulouse
• VILLEJUIF

Germany

• KOELN

GERMANY

• Essen
• Mannheim
• Muenchen

Spain

• BARCELONA
• MADRID
• SALAMANCA
• VALENCIA

SPAIN

• OVIEDO, ASTUR
• Barcelona, BARCE
• MADRID, MADRI

United Kingdom

• ABERDEEN

UNITED KINGDOM

• London
• SUTTON

UNITED STATES

• Tucson, AZ
• Denver, CO
• Boston, MA
• Detroit, MI
• St. Louis, MO
• New York, NY
• Nashville, TN
• HOUSTON, TX
• YAKIMA, WA

Link to trial result