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A Study of RO5185426 in Previously Treated Melanoma Patients With Brain Metastases

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01253564
First received: December 2, 2010
Last updated: November 3, 2014
Last verified: November 2014
  Purpose

This open-label study will assess the safety and efficacy of RO5185426 in previo usly treated metastatic melanoma patients with brain metastases. Patients will r eceive RO5185426 at a dose of 960 mg twice daily orally until disease progressio n or unacceptable toxicity occurs.


Condition Intervention Phase
Malignant Melanoma
Drug: RO5185426
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label, Pilot Study of RO5185426 in Previously Treated Metastatic Melanoma Patients With Brain Metastases

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 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective response rates (ORRs), tumour assessments according to RECIST criteria [ Time Frame: approximately 9 months ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: November 2010
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Arm Drug: RO5185426
960 mg b.i.d. orally

  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
  • Metastatic melanoma (Stage IV, American Joint Committee on Cancer) with BRAF mutation (cobas 4800 BRAF V600 Mutation Test)
  • Brain metastases for which surgical resection is not a treatment option
  • Patients must have failed at least one previous treatment for brain metastases
  • Requiring corticosteroids for symptom control
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2

Exclusion Criteria:

  • Increasing corticosteroid dose during the 7 days prior to study entry
  • Previous malignancy within the past 2 years, except for basal or squamous cell carcinoma of the skin or carcinoma in-situ of the cervix
  • Concurrent administration of any anticancer therapies other than those administered in the study
  • Clinically significant cardiovascular disease or event within the 6 months prior to first dose of study drug
  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: NCT01253564

Locations
Switzerland
Lausanne, Switzerland, 1011
Zürich, Switzerland, 8091
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: NCT01253564     History of Changes
Other Study ID Numbers: MO25653
Study First Received: December 2, 2010
Last Updated: November 3, 2014
Health Authority: Switzerland: Swissmedic

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

ClinicalTrials.gov processed this record on November 25, 2014