A Study of RO5185426 in Patients With Metastatic Melanoma

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01307397
First received: February 17, 2011
Last updated: August 11, 2014
Last verified: August 2014
  Purpose

This open-label, multicenter study will evaluate the safety and efficacy of RO51 85426 in patients with BRAF V600 mutation-positive, surgically incurable and unr esectable stage IIIC or IV metastatic melanoma. Eligible patients will receive R O5185426 (960 mg twice daily orally) until disease progression or unacceptable t oxicity occurs, with a safety follow-up of 24 months after discontinuation of th e study drug.


Condition Intervention Phase
Malignant Melanoma
Drug: RO5185426
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, Multicenter Study to Assess the Safety of RO5185426 in Patients With Metastatic Melanoma

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Safety: Incidence of adverse events [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall Response Rate, tumor assessments according to RECIST criteria [ Time Frame: 22 months ] [ Designated as safety issue: No ]

Enrollment: 3255
Study Start Date: March 2011
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Arm Drug: RO5185426
960 mg twice daily orally

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients, >/= 16 years of age
  • Histologically confirmed metastatic melanoma (surgically incurable and unresectable stage IIIC or stage IV; AJCC) with BRAF V600 mutation determined by Cobas 4800 BRAF Mutation Test
  • Patients may or may not have received prior systemic therapy for metastatic melanoma
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Adequate hematologic, renal and liver function

Exclusion Criteria:

  • Evidence of symptomatic CNS lesions, use of steroids or anti-seizure medications for treatment of brain metastases prior to the first administration of RO5185426
  • Previous malignancy (other than melanoma) within the past 2 years, except for treated and controlled basal or squamous cell carcinoma of the skin or carcinoma in-situ of the cervix
  • Concurrent administration of any anti-cancer therapies other than those administered in the study
  • Clinically significant cardiovascular disease or event within the 6 months prior to first administration of study drug
  • Refractory nausea or vomiting, external biliary shunt, or significant bowel resection that would preclude adequate absorption
  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: NCT01307397

  Show 276 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided by Hoffmann-La Roche

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01307397     History of Changes
Other Study ID Numbers: MO25515
Study First Received: February 17, 2011
Last Updated: August 11, 2014
Health Authority: Greece: Ministry of Health

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 September 16, 2014