Trial record 1 of 1 for:    NCT01898585
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An Open-Label Study of Zelboraf (Vemurafenib) in Patients With Braf V600 Mutation Positive Metastatic Melanoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01898585
First received: July 9, 2013
Last updated: August 4, 2014
Last verified: August 2014
  Purpose

This open-label, single-arm, multicenter study will assess the safety and effica cy of Zelboraf (vemurafenib) in patients with Braf V600 mutation positive metast atic melanoma. Patients will receive Zelboraf 960 mg twice a day until progressi ve disease, unacceptable toxicity, consent withdrawal, death, reasons deemed by the treating physician or study termination.


Condition Intervention Phase
Malignant Melanoma
Drug: Zelboraf
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Single-Arm, Multicenter Study To Assess The Safety Of Vemurafenib In Patients With Braf V600 Mutation Positive Metastatic Melanoma In South Africa.

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Safety: Incidence of adverse events [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall response rate according to Response evaluation criteria in solid tumors (RECIST v1.1) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Progression free survival [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: October 2013
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Zelboraf Arm Drug: Zelboraf
Vemurafenib 960 mg twice a day until progressive disease, unacceptable toxicity, consent withdrawal, death, reasons deemed by the treating physician or study termination.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults patients >= 18 years of age
  • Patients with histologically confirmed metastatic melanoma (surgically incurable and unresectable stage IIIC or stage IV; AJCC) with documented BRAF V600 mutation determined by the cobas® BRAF V600 Mutation Test prior to administration of vemurafenib. Unresectable stage IIIC disease must have confirmation from a surgical oncologist
  • Patients with either measurable or non-measurable disease (RECIST Version 1.1)
  • Patients may or may not have received prior systemic therapy for metastatic melanoma
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
  • Patients must have recovered from all side effects of their most recent systemic or local treatment for metastatic melanoma
  • Adequate hematological, renal, and liver function
  • Negative serum pregnancy test at screening
  • Fertile men and women must use an effective form of contraception during the study and for at least 6 months after completion of the study

Exclusion Criteria:

  • Evidence of symptomatic CNS lesions as determined by the investigator, use of steroid or anti-seizure medication for treatment of brain metastases prior to the first administration of vemurafenib
  • Patients with previous malignancies (other than melanoma) within the past 2 years except patients with treated and controlled basal or squamous cell carcinoma (SCC) of the skin or carcinoma in-situ of the cervix.
  • Concurrent administration of any anti-cancer therapies (e.g. chemotherapy, other targeted therapy, experimental drug, etc.) other than those administered in this study
  • Known hypersensitivity to vemurafenib or another BRAF inhibitor
  • Pregnant or lactating women
  • Refractory nausea and vomiting, malabsorption, external biliary shunt, or significant bowel resection that would preclude adequate absorption.
  • Any of the following within the 6 months prior to the first vemurafenib administration: myocardial infarction, severe/unstable angina, symptomatic congestive heart failure, cerebrovascular accident or transient ischaemic attack, pulmonary embolism, hypertension not adequately controlled by current medications.
  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: NCT01898585

Contacts
Contact: Reference Study ID Number: ML28711 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

Locations
South Africa
Recruiting
Bloemfontein, South Africa, 9301
Recruiting
Cape Town, South Africa, 7700
Recruiting
Cape Town, South Africa, 7570
Recruiting
George, South Africa, 6529
Recruiting
Groenkloof, South Africa, 0181
Recruiting
Johannesburg, South Africa, 2196
Recruiting
Pretoria, South Africa, 0002
Recruiting
Sandton, South Africa, 2196
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01898585     History of Changes
Other Study ID Numbers: ML28711
Study First Received: July 9, 2013
Last Updated: August 4, 2014
Health Authority: South Africa: Medicines Control Council

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on August 20, 2014