Expired Study
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Park Ridge, Illinois 60068


Purpose:

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.


Criteria:

Inclusion Criteria: - 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 Exclusion Criteria: - 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, Tis & Ti) or any cancer curatively treated < 3 years prior to study entry - History of cardiac disease - Known history of human immunodeficiency virus (HIV) infection


Study is Available At:


Original ID:

11715


NCT ID:

NCT00110994


Secondary ID:


Study Acronym:


Brief Title:

Treatment for Subjects With Unresectable Stage III or Stage IV Melanoma


Official Title:

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


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Bayer


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

98


Enrollment Type:

Actual


Overall Contact Information

Official Name:Bayer Study Director
Study Director
Bayer

Study Dates

Start Date:April 2005
Completion Date:March 2008
Completion Type:Actual
Primary Completion Date:October 2006
Primary Completion Type:Actual
Verification Date:January 2009
Last Changed Date:January 14, 2009
First Received Date:May 16, 2005

Study Outcomes

Outcome Type:Primary Outcome
Measure:The primary efficacy objective is to evaluate progression free survival (PFS) between subjects treated with sorafenib versus placebo in combination with DTIC
Time Frame:31 March 2008
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Adverse events collection
Time Frame:Until 30 days after last subject discontinues study treatment
Safety Issues:True
Outcome Type:Secondary Outcome
Measure:Overall Survival
Time Frame:Until occurence of 77th death
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Tumor Response Rate
Time Frame:Until occurence of 77th progression or death
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Time to Progression
Time Frame:Until occurence of 77th progression or death
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Duration of Response
Time Frame:Until occurence of 77th progression or death
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change from Baseline in Performance Status
Time Frame:Until occurence of 77th progression or death
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change from Baseline in EQ-5D Status
Time Frame:Until occurence of 77th progression or death
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Sorafenib (Nexavar, BAY43-9006)
Description:Multi Kinase Inhibitor: Sorafenib, 400 mg, 2 tablets (200 mg each) po bid Study days 1 - 21 + DTIC, 1000 mg/m2 IV on Study Day 1
Arm Name:Arm 1
Intervention Type:Drug
Name:Placebo + Dacarbazine
Description:Placebo + Chemotherapy: Placebo, 2 tablets, po bid Study days 1 - 21 + DTIC, 1000 mg/m2 IV on Study Day 1
Arm Name:Arm 2

Study Arms

Study Arm Type:Experimental
Arm Name:Arm 1
Study Arm Type:Active Comparator
Arm Name:Arm 2

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Bayer

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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