Study Of Zelboraf (Vemurafenib) in Patients With Locally-Advanced, Unresectable, Stage IIIc Or Metastatic Melanoma and Activating Exon 15 BRAF Mutations Other Than V600E
Condition: Malignant Melanoma
MeSH terms: Melanoma
Intervention: Vemurafenib
Intervention description: Vemurafenib 960 mg BID
Intervention MeSH terms: Vemurafenib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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)

        Exclusion Criteria:

          -  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