Status:
COMPLETED
Drug-Drug Interaction - 3 Arm - Carboplatin/Paclitaxel, Dacarbazine
Lead Sponsor:
Bristol-Myers Squibb
Collaborating Sponsors:
Medarex
Conditions:
Advanced Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this clinical research study is to learn the pharmacokinetics of Ipilimumab when combined with Paclitaxel/Carboplatin or Dacarbazine
Eligibility Criteria
Inclusion
- Histologic diagnosis of advanced malignant melanoma
- Eastern Cooperative Oncology Group (ECOG) performances status 0-1
- Measurable/evaluable disease as per modified World Health Organization (mWHO) criteria
Exclusion
- Evidence of active brain metastases
- Prior treatment with anti-cytotoxic lymphocyte antigen 4 (CTLA-4) or anti-CD137 (type of tumor necrosis factor) antibody
- Total Bilirubin greater than (\>) 1.5 \* upper limit of normal (ULN) and aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 2.5 \* upper limit of normal (ULN)
- Prior Autoimmune disease
- Use of immunosuppressing therapies
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT00796991
Start Date
February 1 2009
End Date
October 1 2012
Last Update
January 6 2014
Active Locations (4)
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1
The Angeles Clinic & Research Inst.
Los Angeles, California, United States, 90025
2
H Lee Moffit Cancer Cnt And Res Inst
Tampa, Florida, United States, 33612
3
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10021
4
Blumenthal Cancer Center, Carolinas Medical Center
Charlotte, North Carolina, United States, 28204