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A Randomized, Parallel, Open-Label Study to Compare the Pharmacokinetics of Ipilimumab (BMS-734016) Process C to Process B in Subjects With Advanced Melanoma


Phase 1
18 Years
N/A
Not Enrolling
Both
Advanced Melanoma

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Trial Information

A Randomized, Parallel, Open-Label Study to Compare the Pharmacokinetics of Ipilimumab (BMS-734016) Process C to Process B in Subjects With Advanced Melanoma


Inclusion Criteria:



- Histologic diagnosis of malignant melanoma

- Eastern Cooperative Oncology Group (ECOG) performance status 0-1

- Measurable/evaluable disease per modified World Health Organization (mWHO) criteria

Exclusion Criteria:

- Active Brain Metastasis

- Primary ocular or mucosal melanoma

- Prior Autoimmune disease

- Inadequate hematologic, hepatic or renal function

- Use of immunosuppressants

- Prior treatment with a CD137 agonist or CTLA-4 inhibitor

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Pharmacokinetics of ipilimumab Process B and Process C derived from serum concentration versus time data

Outcome Time Frame:

Up to Week 4 (Day 22) on treatment

Safety Issue:

No

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

United States: Food and Drug Administration

Study ID:

CA184-087

NCT ID:

NCT00920907

Start Date:

August 2009

Completion Date:

October 2012

Related Keywords:

  • Advanced Melanoma
  • Melanoma

Name

Location

Memorial Sloan Kettering Cancer CenterNew York, New York  10021
Carolinas Medical CenterCharlotte, North Carolina  28232-2861
Seattle Cancer Care AllianceSeattle, Washington  98109
California Pacific Medical CenterSan Francisco, California  94115
H Lee Moffitt Cancer CenterTampa, Florida  33612
The Angeles Clinic & Research Inst.Los Angeles, California  90025
St Luke'S Hospital And Health NetworkBethlehem, Pennsylvania  18015