Trial record 1 of 1 for:
NCT01586195
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 is currently recruiting participants.
Verified December 2012 by Genentech
Sponsor:
Genentech
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01586195
First received: April 24, 2012
Last updated: December 4, 2012
Last verified: December 2012
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Purpose
This is an open-label, multicenter, single-agent, 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Malignant Melanoma |
Drug: Zelboraf (vemurafenib) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label 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:
Primary Outcome Measures:
- Best objective response rate (BORR) according to RECIST, v1.1 guidelines [ Time Frame: approximately 18 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Time to response according to RECIST, v1.1 guidelines [ Time Frame: approximately 18 months ] [ Designated as safety issue: No ]
- Duration of response according to RECIST, v1.1 guidelines [ Time Frame: approximately 18 months ] [ Designated as safety issue: No ]
- Progression-free survival (PFS) according to RECIST, v1.1 guidelines [ Time Frame: approximately 18 months ] [ Designated as safety issue: No ]
- Overall survival according to RECIST, v1.1 guidelines [ Time Frame: approximately 18 months ] [ Designated as safety issue: No ]
- Safety: Incidence of adverse events [ Time Frame: approximately 18 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 50 |
| Study Start Date: | October 2011 |
| Estimated Study Completion Date: | September 2016 |
| Estimated Primary Completion Date: | July 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Zelboraf (Vemurafenib) oral repeating dose |
Drug: Zelboraf (vemurafenib)
repeating oral dose
|
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| 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
- Measurable disease (as defined by RECIST, v1.1)
- Adequate recovery from most recent systemic or local treatment for cancer
- Adequate organ function
- Women of childbearing potential and male partners of women of childbearing potential: agreement to use prescribed contraception.
- 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 patients, agreement not to donate sperm during the study and for at least 6 months after discontinuation of vemurafenib
Exclusion Criteria:
- Invasive malignancy other than melanoma at the time of enrollment and within 2 years prior
- Pregnant or breast-feeding
- Concurrent anti-tumor therapy (e.g., chemotherapy, other targeted therapy, radiation therapy, including participation in an experimental drug study)
- Either a concurrent condition 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
- Ongoing cardiac dysrhythmia >/= Grade 2
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01586195
Contacts
| Contact: Please reference Study ID Number: ML27763 www.roche.com/about_roche/roche_worldwide.htm | 888-662-6728 (U.S. Only) | genentechclinicaltrials@druginfo.com |
Locations
| United States, Arizona | |
| Recruiting | |
| Tucson, Arizona, United States, 85724 | |
| United States, California | |
| Recruiting | |
| La Jolla, California, United States, 92093 | |
| Recruiting | |
| Los Angeles, California, United States, 90095 | |
| Recruiting | |
| Santa Monica, California, United States, 90404 | |
| United States, Colorado | |
| Recruiting | |
| Aurora, Colorado, United States, 80045 | |
| United States, Florida | |
| Recruiting | |
| Tampa, Florida, United States, 33612-9497 | |
| United States, Georgia | |
| Not yet recruiting | |
| Atlanta, Georgia, United States, 30308 | |
| United States, Illinois | |
| Recruiting | |
| Park Ridge, Illinois, United States, 60068 | |
| United States, Missouri | |
| Recruiting | |
| St. Louis, Missouri, United States, 63110 | |
| United States, New York | |
| Recruiting | |
| New York, New York, United States, 10032 | |
| United States, Pennsylvania | |
| Recruiting | |
| Pittsburgh, Pennsylvania, United States, 15232 | |
| United States, Tennessee | |
| Recruiting | |
| Nashville, Tennessee, United States, 37232 | |
| United States, Texas | |
| Recruiting | |
| Dallas, Texas, United States, 75246 | |
Sponsors and Collaborators
Genentech
Investigators
| Study Director: | Clinical Trials | Genentech |
More Information
No publications provided
| Responsible Party: | Genentech |
| ClinicalTrials.gov Identifier: | NCT01586195 History of Changes |
| Other Study ID Numbers: | ML27763 |
| Study First Received: | April 24, 2012 |
| Last Updated: | December 4, 2012 |
| Health Authority: | United States: Food and Drug Administration |
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 May 23, 2013