A Study of RO5185426 in Patients With Metastatic Melanoma

Expanded access is no longer available for this treatment.
Sponsor:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01248936
First received: November 24, 2010
Last updated: February 24, 2012
Last verified: February 2012
  Purpose

This is an open-label, non-comparative, multicenter, expanded access study of RO5185426 in patients who have received prior systemic therapy for metastatic melanoma and who have no other satisfactory treatment options.


Condition Intervention Phase
Malignant Melanoma
Drug: RO5185426
Phase 2

Study Type: Expanded Access     What is Expanded Access?
Official Title: A SINGLE ARM, OPEN LABEL, EXPANDED ACCESS STUDY OF RG7204 IN PREVIOUSLY TREATED PATIENTS WITH METASTATIC MELANOMA

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Study Start Date: December 2010
  Eligibility

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

Inclusion Criteria:

  • Histologically confirmed metastatic melanoma with documented BRAF V600E mutation, determined by the cobas BRAF V600 mutation test
  • Patients with clinical evidence of disease progression during or after at least one prior systemic therapy for metastatic melanoma
  • Patients with either measurable or non-measurable disease
  • Adequate recovery from most recent systemic or local treatment for metastatic melanoma
  • Adequate organ funcion
  • For women of childbearing potential, agreement to the use of two acceptable methods of contraception, including one barrier method, during the study and for 6 months after discontinuation of RO5185426
  • For men with female partners of childbearing potential, agreement to use a latex condom, and to advise their female partner to use an additional method of contraception during the study and for 6 months after discontinuation of RO5185426
  • Negative serum or urine pregnancy test within 7 days of commencement of treatment in premenopausal women. Women who are either surgically sterile or have been post-menopausal for at least 1 year are eligible to participate in this study
  • Agreement not to donate blood or blood products during the study and for at least 6 months after disconinuation of RO5185426; for male patients, agreement not to donate sperm during the study and for at least 6 months after discontinuation of RO5185426

Exclusion Criteria:

  • Evidence of symptomatic CNS lesions as determined by investigator
  • Patients with a previous malignancy within the past 2 years are excluded except for patients with basal or squamous cell carcinoma (SCC) of the skin or carcinoma in-situ of the cervix. Isolated elevation in PSA in absence of radiographic evidence of metastatic prostate cancer is allowed
  • Pregnant or breast-feeding
  • Concurrent anti-tumor therapy
  • Any of the following within 6 months prior to study drug administration: myocardial infarction, severe/unstable angina, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, hypertension not adequately controlled by current medications
  • Uncontrolled medical illness
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01248936

  Hide Study Locations
Locations
United States, Arizona
Tucson, Arizona, United States, 85724
United States, California
Los Angeles, California, United States, 90095
San Francisco, California, United States, 94115-2378
San Francisco, California, United States, 94117
Santa Monica, California, United States, 90404
United States, Colorado
Aurora, Colorado, United States, 80045
United States, Connecticut
New Haven, Connecticut, United States, 06520-8063
United States, Florida
Fort Myers, Florida, United States, 33916
Tampa, Florida, United States, 33612-9497
United States, Georgia
Atlanta, Georgia, United States, 30322
United States, Illinois
Park Ridge, Illinois, United States, 60068
United States, Massachusetts
Boston, Massachusetts, United States, 02130
Boston, Massachusetts, United States, 02215
United States, Michigan
Detroit, Michigan, United States, 48201
United States, Missouri
St. Louis, Missouri, United States, 63110
United States, New York
New York, New York, United States, 10065
New York, New York, United States, 10016
New York, New York, United States, 10029
New York, New York, United States, 10032
United States, Ohio
Cincinnati, Ohio, United States, 45242
United States, Oklahoma
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Portland, Oregon, United States, 97213
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, South Carolina
Columbia, South Carolina, United States, 29210
United States, Tennessee
Nashville, Tennessee, United States, 37203
United States, Texas
Dallas, Texas, United States, 75246
United States, Virginia
Richmond, Virginia, United States, 23230
United States, Washington
Seattle, Washington, United States, 98195
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01248936     History of Changes
Other Study ID Numbers: ML25597
Study First Received: November 24, 2010
Last Updated: February 24, 2012
Health Authority: United States: Food and Drug Administration

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 April 17, 2014