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

This study has been terminated.
(Recruitment challenges)
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT01586195
First received: April 24, 2012
Last updated: April 24, 2017
Last verified: April 2017
  Purpose
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.

Condition Intervention Phase
Malignant Melanoma Drug: Vemurafenib Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: An Open-Label, Multicenter, Phase II Study Of Continuous Oral Zelboraf (Vemurafenib) in Patients With Locally-Advanced, Unresectable, Stage IIIc Or Metastatic Melanoma and Activating Exon 15 BRAF Mutations Other Than V600E

Resource links provided by NLM:


Further study details as provided by Genentech, Inc.:

Primary Outcome Measures:
  • Best Objective Response Rate (BORR) [ Time Frame: Up to 42 months ]
    BORR was assessed by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) v1.1. BORR was defined as the number of participants whose best overall response was a complete response (CR) or partial response (PR). CR was defined as complete disappearance of all target lesions and non-target disease. PR was defined as a >/=30% decrease under baseline of the sum of diameters of all target lesions. BORR was summarized along with the associated exact 95% confidence interval (CI) using the method of Clopper-Pearson.


Secondary Outcome Measures:
  • Time to BORR [ Time Frame: From start of treatment up to first documentation of confirmed CR or PR (up to 42 months) ]
    In participants with a confirmed CR or PR, time to BORR was defined as the interval between the date of first treatment and the date of first documentation of confirmed CR or PR (whichever occurred first). BORR was assessed by the investigators according to RECIST v1.1. CR was defined as complete disappearance of all target lesions and non-target disease. PR was defined as a >/=30% decrease under baseline of the sum of diameters of all target lesions. Participants without confirmed CR or PR were censored at the date of last tumor assessment. The time to response was summarized using univariate statistics.

  • Duration of Response [ Time Frame: From date of earliest qualifying response up to date of disease progression or death (up to 42 months) ]
    In participants with a confirmed CR or PR, duration of response was defined as the time interval between the date of the earliest qualifying response and the date of progressive disease (PD) or death due to any cause. CR was defined as complete disappearance of all target lesions and non-target disease. PR was defined as a >/=30% decrease under baseline of the sum of diameters of all target lesions. PD was defined as a 20% increase in the sum of the longest diameter of target lesions or the appearance of new lesions and increase of at least 5 mm in the sum of diameters of target lesions. Duration of response was summarized using Kaplan-Meier method.

  • Progression-free Survival (PFS) [ Time Frame: From start of treatment up to first documentation of disease progression or death (up to 42 months) ]
    PFS was assessed by the investigators according to RECIST v1.1 and defined as the time interval between the date of the first treatment dose and the date of disease progression or death due to any cause, whichever occurred first. PD was defined as a 20% increase in the sum of the longest diameter of target lesions or the appearance of new lesions and increase of at least 5 mm in the sum of diameters of target lesions. PFS was summarized using Kaplan-Meier method.

  • Overall Survival (OS) [ Time Frame: Date of first treatment to date of death due to any cause (up to 42 months) ]
    OS was defined as the time from the date of first treatment to the date of death due to any cause. OS was summarized using Kaplan-Meier method.

  • Percentage of Participants With 6-Month Survival [ Time Frame: Baseline to Month 6 ]
  • Percentage of Participants With 12-Month Survival [ Time Frame: Baseline to Month 12 ]
  • Number of Participants With an Adverse Event (AE) [ Time Frame: Up to 42 months ]
    An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational medicinal product (IMP) or other protocol-imposed intervention, regardless of attribution.


Enrollment: 31
Actual Study Start Date: October 31, 2011
Study Completion Date: April 30, 2015
Primary Completion Date: April 30, 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vemurafenib
Participants with untreated or previously treated locally advanced, unresectable, Stage IIIc or metastatic melanoma who have an activating exon 15 BRAF mutation other than V600E received vemurafenib 960 milligram (mg) orally twice daily (BID) until disease progression.
Drug: Vemurafenib
Vemurafenib 960 mg BID
Other Name: Zelboraf

  Eligibility

Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  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: NCT01586195

Locations
United States, Arizona
Arizona Cancer Center
Tucson, Arizona, United States, 85724
United States, California
UCSD Moores Cancer Center
La Jolla, California, United States, 92093
UCLA School of Medicine; Hematology/Oncology
Los Angeles, California, United States, 90095
The Angeles Clinic and Research Institute, Santa Monica Office
Santa Monica, California, United States, 90025
United States, Colorado
University of Colorado; Anschutz Cancer Pavilion
Aurora, Colorado, United States, 80045
United States, Florida
Moffitt Cancer Center
Tampa, Florida, United States, 33612
United States, Georgia
Emory University; Winship Cancer Institute
Atlanta, Georgia, United States, 30308
United States, Illinois
Oncology Specialists, S.C.
Park Ridge, Illinois, United States, 60068
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
United States, New Jersey
Atlantic Health System
Morristown, New Jersey, United States, 07960
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
United States, Ohio
Mid Ohio Onc Hematology Inc
Columbus, Ohio, United States, 43219
United States, Pennsylvania
UPCI Cancer Institute; Cancer Pavillion
Pittsburgh, Pennsylvania, United States, 15232
United States, Tennessee
Vanderbilt Univ Medical Ctr
Nashville, Tennessee, United States, 37232
United States, Texas
Texas Oncology-Baylor Sammons Cancer Center
Dallas, Texas, United States, 75246
Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Clinical Trials Genentech, Inc.
  More Information

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT01586195     History of Changes
Other Study ID Numbers: ML27763
Study First Received: April 24, 2012
Results First Received: July 7, 2016
Last Updated: April 24, 2017

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 June 26, 2017