A Study of RO5185426 in Patients With Metastatic Melanoma
A SINGLE ARM, OPEN LABEL, EXPANDED ACCESS STUDY OF RG7204 IN PREVIOUSLY TREATED PATIENTS WITH METASTATIC MELANOMA
1 other identifier
interventional
374
1 country
28
Brief Summary
This is an open-label, non-comparative, multicenter, expanded access study of RO5185426 in patients who have received prior systemic therapy for metastatic melanoma and who have no other satisfactory treatment options.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2010
Shorter than P25 for phase_2
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 24, 2010
CompletedFirst Posted
Study publicly available on registry
November 25, 2010
CompletedStudy Start
First participant enrolled
December 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedResults Posted
Study results publicly available
February 11, 2016
CompletedAugust 12, 2016
July 1, 2016
10 months
November 24, 2010
January 13, 2016
July 12, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
Number of Participants With Any Adverse Event, Adverse Events With Severity, Adverse Events Leading to Discontinuation
An Adverse Event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs will be graded according to the 'National Cancer Institute Common Terminology Criteria for Adverse Events' (NCI CTCAE, v4.0). However Laboratory data will be summarized by grade using the NCI CTCAE, v4.0 toxicity grade.
Up to 1 year
Number of Participants With Any Serious Adverse Event, Death and Cause of Death
Serious Adverse Event (SAEs) is defined as those events that were fatal or immediately life-threatening, and those events that resulted in hospitalization; prolonged an existing hospitalization; resulted in disability; or was a congenital anomaly. Number of participants who died and the cause of death are also recorded.
Up to 1 year
Secondary Outcomes (5)
Number of Participants With Best Overall Response (Unconfirmed)
Up to 1 year
Number of Participants With Best Overall Response (Unconfirmed) by ECOG Performance
Up to 1 year
Number of Participants With Best Overall Response (Confirmed)
Up to 1 year
Number of Participants With Best Overall Response (Confirmed) by ECOG Performance
Up to 1 year
Mean Time to Complete Response/Partial Response
Up to 1 year
Study Arms (1)
Overall Trial
EXPERIMENTALParticipants 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
Interventions
Eligibility Criteria
You may qualify if:
- Histologically confirmed metastatic melanoma with documented BRAF V600E mutation, determined by the cobas BRAF V600 mutation test
- 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
You may not qualify if:
- Pregnant or breast-feeding
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (28)
Unknown Facility
Tucson, Arizona, 85724-5078, United States
Unknown Facility
Los Angeles, California, 90095, United States
Unknown Facility
San Francisco, California, 94115, United States
Unknown Facility
San Francisco, California, 94117, United States
Unknown Facility
Santa Monica, California, 90025, United States
Unknown Facility
Aurora, Colorado, 80045, United States
Unknown Facility
New Haven, Connecticut, 06520-8063, United States
Unknown Facility
Palm Harbor, Florida, 34684, United States
Unknown Facility
Tampa, Florida, 33612-9497, United States
Unknown Facility
Atlanta, Georgia, 30322, United States
Unknown Facility
Park Ridge, Illinois, 60068, United States
Unknown Facility
Boston, Massachusetts, 02114, United States
Unknown Facility
Boston, Massachusetts, 02215, United States
Unknown Facility
Detroit, Michigan, 48201, United States
Unknown Facility
St Louis, Missouri, 63110, United States
Unknown Facility
New York, New York, 10016, United States
Unknown Facility
New York, New York, 10029, United States
Unknown Facility
New York, New York, 10032, United States
Unknown Facility
New York, New York, 10065, United States
Unknown Facility
Cincinnati, Ohio, 45242, United States
Unknown Facility
Oklahoma City, Oklahoma, 73104, United States
Unknown Facility
Portland, Oregon, 97225, United States
Unknown Facility
Philadelphia, Pennsylvania, 19104, United States
Unknown Facility
Columbia, South Carolina, 29210, United States
Unknown Facility
Nashville, Tennessee, 37203, United States
Unknown Facility
Dallas, Texas, 75246, United States
Unknown Facility
Richmond, Virginia, 23230, United States
Unknown Facility
Seattle, Washington, 98195, United States
Related Publications (1)
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.
PMID: 24983357DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Roche Trial Information Hotline
- Organization
- F. Hoffmann-La Roche AG
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
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
November 24, 2010
First Posted
November 25, 2010
Study Start
December 1, 2010
Primary Completion
October 1, 2011
Study Completion
October 1, 2011
Last Updated
August 12, 2016
Results First Posted
February 11, 2016
Record last verified: 2016-07