Status:
COMPLETED
A Safety and Efficacy Study of Intetumumab, Alone and in Combination With Dacarbazine, in Participants With Stage 4 Melanoma
Lead Sponsor:
Centocor, Inc.
Collaborating Sponsors:
Janssen-Cilag Farmaceutica, S.R.L.
Conditions:
Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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.
Detailed Description
This is a Phase 1/2, multi-center, randomized (the study medication is assigned by chance) study. This study will be conducted in 2 Phases (Phase 1 and Phase 2). Phase 1 of this study will be non-rand...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT00246012
Start Date
May 1 2005
End Date
February 1 2009
Last Update
August 19 2013
Active Locations (32)
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1
Scottsdale, Arizona, United States
2
La Jolla, California, United States
3
Santa Monica, California, United States
4
Walnut Creek, California, United States