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Melanoma

RO5185426 for Metastatic Melanoma (Expanded Access)
A Single Arm, Open Label, Expanded Access Study Of RO5185426 In Previously Treated Patients With Metastatic Melanoma
Status Conditions Phase Study ID
Closed Malignant Melanoma Phase II NCT01248936
Summary

This is an open-label, non-comparative, multicenter, expanded access study of RO5185426 (a BRAF inhibitor) in patients who have received prior systemic therapy for metastatic melanoma and who have no other satisfactory treatment options. (RO5185426 goes by several names including vemurafenib and PLX4032.)

Patients will come to SCCA every four weeks for treatment. Visits will include a blood draw and scan (CT or MRI of known areas of disease, normally chest, abdomen and pelvis, sometimes neck, brain or extremities as well) every eight to 16 weeks, depending on how frequent their physician thinks these scans should be. Patients on this clinical trial can only receive treatment at SCCA (or another center where this study is open).

What is Expanded Access? Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial. Read more about expanded access.


Investigator
Kim Margolin, M.D.
Location    
Seattle Cancer Care Alliance 800-804-8824  
Eligibility Criteria (must meet the following to participate in this study)
  • 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
Exclusions (conditions that would prevent participation in this study)
  • 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
Last Updated
November 21, 2011
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.