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Treatment for Subjects With Unresectable Stage III or Stage IV Melanoma

Information source: Bayer
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cancer; Melanoma

Intervention: Sorafenib (Nexavar, BAY43-9006) (Drug); Placebo (Drug); Dacarbazine (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Progression Free Survival (PFS)

Secondary outcome:

Overall Survival (OS)

Number of Participants in Tumor Response Categories

Time to Progression (TTP)

Duration of Response (DOR)

Change in Eastern Cooperative Oncology Group (ECOG) Performance Status From Baseline to the Visit When the Best Tumor Response Was Noted

Change of European Quality of Life 5-dimensional (EQ-5D) Questionnaire Index Score From Baseline to the Visit at Which Best Response Was First Noted

Change of European Quality of Life 5-dimensional (EQ-5D) Questionnaire Index Score From Baseline to the End of Treatment

Change of European Quality of Life Visual Analogue Scale (EQ-VAS) Score From Baseline to the Visit at Which Best Response Was First Noted

Change of European Quality of Life Visual Analogue Scale (EQ-VAS) Score From Baseline to the End of Treatment

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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 [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

Locations and Contacts

Tucson, Arizona 85724, United States

Aurora, Colorado 80045, United States

Lakeland, Florida 33805, United States

Park Ridge, Illinois 60068, United States

Boston, Massachusetts 02114, United States

Boston, Massachusetts 02115-6084, United States

Boston, Massachusetts 02215, United States

St. Louis, Missouri 63110-1093, United States

Omaha, Nebraska 68114, United States

Charlotte, North Carolina 28203, United States

Pittsburgh, Pennsylvania 15232, United States

Hilton Head Island, South Carolina 29926-2739, United States

Nashville, Tennessee 37232-6307, United States

San Antonio, Texas 78229, United States

Additional Information

Click here and search for drug information provided by the FDA.

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.

Starting date: April 2005
Last updated: May 13, 2015

Page last updated: August 20, 2015

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