Treatment for Subjects With Unresectable Stage III or Stage IV Melanoma
Phase II Randomized, Placebo Controlled Study of Sorafenib in Repeated Cycles of 21 Days in Combination With Dacarbazine (DTIC) Chemotherapy in Subjects With Unresectable Stage III or Stage IV Melanoma
1 other identifier
interventional
101
1 country
14
Brief Summary
This is a randomized, double blind, placebo controlled, multicenter, phase II study to compare the anti-tumor activity as measured by progression-free survival (PFS) and the tolerability of Sorafenib in combination with Dacarbazine (DTIC) versus DTIC in combination with placebo in subjects with unresectable Stage III or Stage IV melanoma who have not received prior cytotoxic chemotherapy. A total of approximately 98 subjects will be randomized to receive DTIC + Sorafenib or DTIC + Placebo.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 cancer
Started Apr 2005
14 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
Study Start
First participant enrolled
April 1, 2005
CompletedFirst Submitted
Initial submission to the registry
May 16, 2005
CompletedFirst Posted
Study publicly available on registry
May 17, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2008
CompletedResults Posted
Study results publicly available
June 1, 2011
CompletedJune 8, 2015
May 1, 2015
1.5 years
May 16, 2005
January 26, 2011
May 13, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Progression Free Survival (PFS)
PFS was calculated as the time (days) from date of randomization to date of first observed DP (per modified Response Evaluation Criteria In Solid Tumors \[RECIST\] or clinical judgment, whichever was earlier: CR, PR, stable disease, progressive disease) or death due to any cause, if death occurred before progression was documented. The actual date of tumor assessments was used for this calculation. PFS for subjects without progression or death was censored at the last date of tumor evaluation. PFS for subjects who had no tumor assessments after baseline and did not die was censored at 1 day.
Time from randomization to documented tumor progression or death (the maximum treatment duration of 71.1 weeks)
Secondary Outcomes (9)
Overall Survival (OS)
Time from randomization to death (the maximum treatment duration of 71.1 weeks)
Number of Participants in Tumor Response Categories
Every 6 weeks from the start of the treatment until the end of treatment visit with a median of 134 days
Time to Progression (TTP)
Time from randomization to documented tumor progression (median time of 148 days)
Duration of Response (DOR)
Time from initial response to documented tumor progression or death (median time of 188 days)
Change in Eastern Cooperative Oncology Group (ECOG) Performance Status From Baseline to the Visit When the Best Tumor Response Was Noted
Baseline and every 6 weeks from the start of the treatment until the end of treatment visit with a median of 134 days
- +4 more secondary outcomes
Study Arms (2)
Sorafenib (Nexavar, BAY43-9006) + Dacarbazine
EXPERIMENTALSorafenib, 2 tablets (200 mg each) orally twice daily (bid) on study days 1-21 + Dacarbazine, 1000 mg/m\^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
Placebo + Dacarbazine
ACTIVE COMPARATORPlacebo, 2 tablets orally twice daily on study days 1-21 + Dacarbazine, 1000 mg/m\^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
Interventions
Sorafenib, 400 mg, 2 tablets (200 mg each) po (per os) bid (twice daily) Study days 1-21
Dacarbazine, 1000 mg/m\^2 intravenous on Study Day 1
Eligibility Criteria
You may qualify if:
- Patients who have a life expectancy of at least 12 weeks
- Patients with histologically or cytologically confirmed unresectable (Stage III) or metastatic (Stage IV) melanoma
- Patients who have an ECOG PS of 0, or 1
- Measurable disease defined as at least one lesion that can be accurately and serially measured per the modified RECIST criteria
You may not qualify if:
- Primary ocular or mucosal melanoma
- Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta \[Noninvasive papillary carcinoma\], Tis \[Carcinoma in situ: "flat tumor"\] \& T1 \[Tumor invades subepithelial connective tissue\]) or any cancer curatively treated \< 3 years prior to study entry
- History of cardiac disease
- Known history of human immunodeficiency virus (HIV) infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Unknown Facility
Tucson, Arizona, 85724, United States
Unknown Facility
Aurora, Colorado, 80045, United States
Unknown Facility
Lakeland, Florida, 33805, United States
Unknown Facility
Park Ridge, Illinois, 60068, United States
Unknown Facility
Boston, Massachusetts, 02114, United States
Unknown Facility
Boston, Massachusetts, 02115-6084, United States
Unknown Facility
Boston, Massachusetts, 02215, United States
Unknown Facility
St Louis, Missouri, 63110-1093, United States
Unknown Facility
Omaha, Nebraska, 68114, United States
Unknown Facility
Charlotte, North Carolina, 28203, United States
Unknown Facility
Pittsburgh, Pennsylvania, 15232, United States
Unknown Facility
Hilton Head Island, South Carolina, 29926-2739, United States
Unknown Facility
Nashville, Tennessee, 37232-6307, United States
Unknown Facility
San Antonio, Texas, 78229, United States
Related Publications (1)
McDermott DF, Sosman JA, Gonzalez R, Hodi FS, Linette GP, Richards J, Jakub JW, Beeram M, Tarantolo S, Agarwala S, Frenette G, Puzanov I, Cranmer L, Lewis K, Kirkwood J, White JM, Xia C, Patel K, Hersh E. Double-blind randomized phase II study of the combination of sorafenib and dacarbazine in patients with advanced melanoma: a report from the 11715 Study Group. J Clin Oncol. 2008 May 1;26(13):2178-85. doi: 10.1200/JCO.2007.14.8288.
PMID: 18445842RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Therapeutic Area Head
- Organization
- BAYER
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 16, 2005
First Posted
May 17, 2005
Study Start
April 1, 2005
Primary Completion
October 1, 2006
Study Completion
March 1, 2008
Last Updated
June 8, 2015
Results First Posted
June 1, 2011
Record last verified: 2015-05