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

NCT01586195 | Terminated Phase 2 Results DMC

• 1 other identifier: ML27763
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 15

Brief 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.

Conditions

Malignant Melanoma

Outcome Measures

Primary Outcomes (1)

• Best Objective Response Rate (BORR)

  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.

  Up to 42 months

Secondary Outcomes (7)

• Time to BORR

  From start of treatment up to first documentation of confirmed CR or PR (up to 42 months)

• Duration of Response

  From date of earliest qualifying response up to date of disease progression or death (up to 42 months)

• Progression-free Survival (PFS)

  From start of treatment up to first documentation of disease progression or death (up to 42 months)

• Overall Survival (OS)

  Date of first treatment to date of death due to any cause (up to 42 months)

• Percentage of Participants With 6-Month Survival

  Baseline to Month 6

Study Arms (1)

Vemurafenib

EXPERIMENTAL

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

Interventions

Vemurafenib DRUG

Vemurafenib 960 mg BID

Also known as: Zelboraf

Vemurafenib

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Genentech, Inc.: lead

Study Sites (15)

Arizona Cancer Center

Tucson, Arizona, 85724, United States

Location

UCSD Moores Cancer Center

La Jolla, California, 92093, United States

Location

UCLA School of Medicine; Hematology/Oncology

Los Angeles, California, 90095, United States

Location

The Angeles Clinic and Research Institute, Santa Monica Office

Santa Monica, California, 90025, United States

Location

University of Colorado; Anschutz Cancer Pavilion

Aurora, Colorado, 80045, United States

Location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Emory University; Winship Cancer Institute

Atlanta, Georgia, 30308, United States

Location

Oncology Specialists, S.C.

Park Ridge, Illinois, 60068, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Atlantic Health System

Morristown, New Jersey, 07960, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Mid Ohio Onc Hematology Inc

Columbus, Ohio, 43219, United States

Location

UPCI Cancer Institute; Cancer Pavillion

Pittsburgh, Pennsylvania, 15232, United States

Location

Vanderbilt Univ Medical Ctr

Nashville, Tennessee, 37232, United States

Location

Texas Oncology-Baylor Sammons Cancer Center

Dallas, Texas, 75246, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

Vemurafenib

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800-821-8590

Study Officials

• Clinical Trials

  Genentech, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2012
• First Posted: April 26, 2012
• Study Start: October 31, 2011
• Primary Completion: April 30, 2015
• Study Completion: April 30, 2015
• Last Updated: May 25, 2017
• Results First Posted: May 25, 2017

Record last verified: 2017-04

Locations

US (15)