Study Of Zelboraf (Vemurafenib) in Patients With Locally-Advanced, Unresectable, Stage IIIc Or Metastatic Melanoma and Activating Exon 15 BRAF Mutations Other Than V600E

Stopped early · Phase 2

Conditions studied: Malignant Melanoma

In brief

This is an open-label, multicenter, single-agent, phase II study of continuous oral Zelboraf (vemurafenib) in participants with locally-advanced, unresectable, stage IIIc or metastatic melanoma and activating exon 15 BRAF mutations other than V600E.

Key facts

Study ID

NCT01586195

Run by

Genentech, Inc.

People needed

31

Starts

2011-10-31

Expected to finish

2015-04-30

Last updated by the study team

2017-05-25

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
• Histologically-confirmed metastatic melanoma (unresectable Stage IIIc or IV) with an activating BRAF mutation other than V600E, as detected by DNA sequencing of exon 15 performed at a centralized laboratory
• Measurable disease (as defined by RECIST, v1.1)
• Adequate recovery from most recent systemic or local treatment for cancer
• Adequate organ function within 28 days prior to initiation of treatment
• 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 vemurafenib
• 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 vemurafenib
• Negative serum 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 discontinuation of vemurafenib; for male participants, agreement not to donate sperm during the study and for at least 6 months after discontinuation of vemurafenib
• Signed informed consent form (prior to study entry and before performing any study-related procedures)

You may not qualify if…

• Invasive malignancy other than melanoma at the time of enrollment and within 2 years prior to first study drug administration, except for adequately treated (with curative intent) basal or squamous cell carcinoma, in situ carcinoma of the cervix, in situ ductal adenocarcinoma of the breast, in situ prostate cancer, or limited stage bladder cancer or other cancers from which the patient has been disease-free for at least 2 years
• Pregnant or breast-feeding
• Inability to swallow pills
• Concurrent anti-tumor therapy (e.g., chemotherapy, other targeted therapy, radiation therapy, including participation in an experimental drug study)
• Radiation therapy </= 1 week prior to first administration of vemurafenib and stereotactic radiotherapy </= 1 day prior to first administration of vemurafenib
• Prior treatment with a BRAF or MEK inhibitor
• Either a concurrent condition (including medical illness, such as active infection requiring treatment with IV antibiotics or the presence of laboratory abnormalities) or history of a prior condition that places the patient at unacceptable risk if he/she were treated with the study drug or confounds the ability to interpret data from the study
• History of congenital long QT syndrome or a corrected QT (QTc) interval > 450 ms at baseline
• Ongoing cardiac dysrhythmia >/= Grade 2
• Unwillingness to practice effective birth control
• Inability to comply with other requirements of the protocol

Where it is running

• Arizona Cancer Center — Tucson, Arizona, United States
• UCSD Moores Cancer Center — La Jolla, California, United States
• UCLA School of Medicine; Hematology/Oncology — Los Angeles, California, United States
• The Angeles Clinic and Research Institute, Santa Monica Office — Santa Monica, California, United States
• University of Colorado; Anschutz Cancer Pavilion — Aurora, Colorado, United States
• Moffitt Cancer Center — Tampa, Florida, United States
• Emory University; Winship Cancer Institute — Atlanta, Georgia, United States
• Oncology Specialists, S.C. — Park Ridge, Illinois, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Atlantic Health System — Morristown, New Jersey, United States
• Columbia University Medical Center — New York, New York, United States
• Mid Ohio Onc Hematology Inc — Columbus, Ohio, United States
• UPCI Cancer Institute; Cancer Pavillion — Pittsburgh, Pennsylvania, United States
• Vanderbilt Univ Medical Ctr — Nashville, Tennessee, United States
• Texas Oncology-Baylor Sammons Cancer Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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