A Safety and Efficacy Study of Intetumumab, Alone and in Combination With Dacarbazine, in Participants With Stage 4 Melanoma

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Melanoma

In brief

The purpose of this study is to evaluate the safety and effectiveness of the intetumumab, alone and in combination with dacarbazine, in patients with stage 4 melanoma.

Key facts

Study ID

NCT00246012

Run by

Centocor, Inc.

People needed

144

Starts

2005-05-01

Expected to finish

2009-02-01

Last updated by the study team

2013-08-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed melanoma including ocular and mucosal
• Documented AJCC (American Joint Committee on Cancer) Stage 3 unresectable or Stage 4 melanoma (Phase 1); AJCC Stage 4 melanoma (Phase 2)
• Radiographically measurable disease or measurable skin lesions
• Prior chemotherapy for metastatic melanoma will be allowed for Phase 1, while previously untreated for melanoma by chemotherapy will be allowed for Phase 2
• Agrees to protocol-defined use of effective contraception

You may not qualify if…

• History of receiving murine or human/murine recombination products of human αν integrins
• Known human immunodeficiency virus (HIV) positivity and clinically important active infection
• Presence of bone metastases or malignant effusions (non-measurable lesions) and central nervous system metastases
• Prior radiation to target lesions
• Concurrent immunotherapy, biotherapy, radiotherapy, chemotherapy, or investigational therapy and therapeutic use of anticoagulation

Where it is running

• Study site — Scottsdale, Arizona, United States
• Study site — La Jolla, California, United States
• Study site — Santa Monica, California, United States
• Study site — Walnut Creek, California, United States
• Study site — Aurora, Colorado, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Miami, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Park Ridge, Illinois, United States
• Study site — Beech Grove, Indiana, United States
• Study site — Omaha, Nebraska, United States
• Study site — Buffalo, New York, United States
• Study site — New York, New York, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Nashville, Tennessee, United States
• Study site — Dallas, Texas, United States
• Study site — Seattle, Washington, United States
• Study site — Berlin, Germany
• Study site — Bonn, Germany
• Study site — Buxtehude, Germany
• Study site — Düsseldorf, Germany
• Study site — Essen, Germany
• Study site — Hanover, Germany
• Study site — Jena, Germany
• Study site — Kiel, Germany

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.