A Study of RO5185426 in Patients With Metastatic Melanoma
NCT ID: NCT01248936
Last Updated: 2016-08-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
374 participants
INTERVENTIONAL
2010-12-31
2011-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Overall Trial
Participants received vemurafenib 960 milligram (mg) orally two times a day for up to one year. Participants were treated until disease progression, unmanageable toxicity most probably attributable to vemurafenib, withdrawal of consent, and study termination by the sponsor
RO5185426
Interventions
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RO5185426
Eligibility Criteria
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Inclusion Criteria
* Patients with either measurable or non-measurable disease
* Adequate recovery from most recent systemic or local treatment for metastatic melanoma
* Adequate organ function
* 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 RO5185426
* 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 RO5185426
* Negative serum or urine 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 RO5185426; for male patients, agreement not to donate sperm during the study and for at least 6 months after discontinuation of RO5185426
Exclusion Criteria
* Concurrent anti-tumor therapy
* Uncontrolled medical illness
* History of congenital prolonged QT syndrome or patients with a mean QTc interval greater than 470 milliseconds at baseline, or ongoing grade 2 or greater cardiac arrhythmia
16 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Tucson, Arizona, United States
Los Angeles, California, United States
San Francisco, California, United States
San Francisco, California, United States
Santa Monica, California, United States
Aurora, Colorado, United States
New Haven, Connecticut, United States
Palm Harbor, Florida, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Park Ridge, Illinois, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Detroit, Michigan, United States
St Louis, Missouri, United States
New York, New York, United States
New York, New York, United States
New York, New York, United States
New York, New York, United States
Cincinnati, Ohio, United States
Oklahoma City, Oklahoma, United States
Portland, Oregon, United States
Philadelphia, Pennsylvania, United States
Columbia, South Carolina, United States
Nashville, Tennessee, United States
Dallas, Texas, United States
Richmond, Virginia, United States
Seattle, Washington, United States
Countries
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References
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Frederick DT, Salas Fragomeni RA, Schalck A, Ferreiro-Neira I, Hoff T, Cooper ZA, Haq R, Panka DJ, Kwong LN, Davies MA, Cusack JC, Flaherty KT, Fisher DE, Mier JW, Wargo JA, Sullivan RJ. Clinical profiling of BCL-2 family members in the setting of BRAF inhibition offers a rationale for targeting de novo resistance using BH3 mimetics. PLoS One. 2014 Jul 1;9(7):e101286. doi: 10.1371/journal.pone.0101286. eCollection 2014.
Other Identifiers
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ML25597
Identifier Type: -
Identifier Source: org_study_id
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