Clinical trial NCT00796991: Drug-Drug Interaction - 3 Arm - Carboplatin/Paclitaxel, Dacarbazine
Official title: A Randomized, Parallel, 3-arm Study to Characterize the Effect of Ipilimumab + Chemotherapy in Patients With Untreated Advanced Melanoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Melanoma
Keywords: Untreated Advanced Melanoma
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: Medarex
First posted: 2008-11-24
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Pharmacokinetic Parameter Maximum Observed Serum Concentration (Cmax) for Ipilimumab, Paclitaxel, Dacarbazine and the Active Metabolite for Dacarbazine, 5-aminoimidazole-4carboxamide (AIC)- Pharmacokinetic Analysis Population
timeFrame: Day 1 (0 h) to Day 43
measure: Area Under the Concentration Time Curve (AUC) From Time Zero to 21 Days [AUC(0-21d)] for Ipilimumab and AUC Time Zero Extrapolated to Infinity [AUC(INF)] for Paclitaxel, Dacarbazine and the Active Metabolite AIC - Pharmacokinetic Analysis Population
timeFrame: Day 1 (0 h) to Day 43
Secondary outcomes:
measure: Pharmacokinetic Parameter of Time of Maximum Observed Concentration (Tmax) for Ipilimumab, Paclitaxel, Dacarbazine and Active Metabolite AIC - Pharmacokinetic Analysis Population
timeFrame: Day 1 (0 h) to Day 43
measure: Pharmacokinetic Parameter of Terminal Elimination Half Life (T-HALF) for Ipilimumab, Paclitaxel, Dacarbazine and Active Metabolite AIC - Pharmacokinetic Analysis Population
timeFrame: Day 1 (0 h) to Day 43
measure: Pharmacokinetic Parameter of Clearance (CLT) for Ipilimumab, Paclitaxel, Dacarbazine and Active Metabolite AIC - Pharmacokinetic Analysis Population
timeFrame: Day 1 (0 h) to Day 43
measure: Pharmacokinetic Parameter Volume of Distribution at Steady State (Vss) for Ipilimumab, Paclitaxel, Dacarbazine and Active Metabolite AIC - Pharmacokinetic Analysis Population
timeFrame: Day 1 (0 h) to Day 43
measure: Number of Participants in Best Overall Response Categories Based on Modified World Health Organization (mWHO) Criteria - All Treated Participants
timeFrame: Day 1 to Week 48
measure: Number of Participants in Best Overall Response Categories Based on Immune Related (ir) Response Criteria (RC) - All Treated Participants
timeFrame: Day 1 to Week 48
measure: Number of Participants With Objective Response to Treatment and Disease Control Using mWHO Criteria - All Randomized Participants
timeFrame: Day 1 to Week 48
measure: Number of Participants With Adverse Events, Serious Adverse Events, Deaths, and Discontinuation Due to Adverse Events From Day 1 to Week 48 - All Treated Population
timeFrame: Day 1 to Week 48
measure: Mean Absolute Lymphocyte Count (ALC) at Each Nominal Ipilimumab Induction Dose and at End of the Induction Period - Pharmacodynamic Population
timeFrame: Day to Week 12
measure: Mean Change From Baseline at Weeks 16 and 48 in Diastolic and Systolic Blood Pressure - All Treated Population
timeFrame: Day 1 to Week 48
measure: Mean Change From Baseline in Pulse Rate at Weeks 16 and 48 - All Treated Population
timeFrame: Day 1 to Week 48
measure: Mean Change From Baseline in Respiration Rate at Weeks 16 and 48 - All Treated Population
timeFrame: Day 1 to Week 48
measure: Mean Baseline Change in Body Temperature at Weeks 16 and 48 - All Treated Population
timeFrame: Day 1 to Week 48
measure: Number of Participants on Treatment With Toxicity Changes From Baseline by Worst Common Terminology Criteria (CTC) Grade for Hemoglobin - All Treated Population
timeFrame: Day 1 to Week 48
measure: Number of Participants on Treatment With Toxicity Changes From Baseline by Worst Common Terminology Criteria (CTC) Grade for Leukocytes - All Treated Population
timeFrame: Day 1 to Week 48
measure: Number of Participants on Treatment With Toxicity Changes From Baseline by Worst Common Terminology Criteria (CTC) Grade for Lymphocytes - All Treated Population
timeFrame: Day 1 to Week 48
measure: Number of Participants on Treatment With Toxicity Changes From Baseline by Worst CTC Grade for Neutrophils - All Treated Population
timeFrame: Day 1 to Week 48
measure: Number of Participants on Treatment With Toxicity Changes From Baseline by Worst CTC Grade for Neutrophils Plus Bands - All Treated Population
timeFrame: Day 1 to Week 48
measure: Number of Participants on Treatment With Toxicity Changes From Baseline by Worst CTC Grade for Platelet Count - All Treated Population
timeFrame: Day 1 to Week 48
measure: Number of Participants on Treatment With Toxicity Changes From Baseline by Worst CTC Grade for Alanine Aminotransferase (ALT) - All Treated Population
timeFrame: Day 1 to Week 48
measure: Number of Participants on Treatment With Toxicity Changes From Baseline by Worst CTC Grade for Aspartate Aminotransferase (AST) - All Treated Population
timeFrame: Day 1 to Week 48
measure: Number of Participants on Treatment With Toxicity Changes From Baseline by Worst CTC Grade for Albumin - All Treated Population
timeFrame: Day 1 to Week 48
measure: Number of Participants on Treatment With Toxicity Changes From Baseline by Worst CTC Grade for Alkaline Phosphatase - All Treated Population
timeFrame: Day 1 to Week 48
measure: Number of Participants on Treatment With Toxicity Changes From Baseline by Worst CTC Grade for Total Bilirubin - All Treated Population
timeFrame: Day 1 to Week 48
measure: Number of Participants on Treatment With Toxicity Changes From Baseline by Worst CTC Grade for Serum Potassium (High) - All Treated Population
timeFrame: Day 1 to Week 48
measure: Number of Participants on Treatment With Toxicity Changes From Baseline by Worst CTC Grade for Total Amylase - All Treated Population
timeFrame: Day 1 to Week 48
measure: Number of Participants on Treatment With Toxicity Changes From Baseline by Worst CTC Grade for Total Calcium (High) - All Treated Population
timeFrame: Day 1 to Week 48
measure: Number of Participants on Treatment With Toxicity Changes From Baseline by Worst CTC Grade for Total Lipase - All Treated Population
timeFrame: Day 1 to Week 48
measure: Number of Participants on Treatment With Toxicity Changes From Baseline by Worst CTC Grade for Uric Acid - All Treated Population
timeFrame: Day 1 to Week 48
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: The Angeles Clinic & Research Inst.
state: California
city: Tampa
country: United States
facility: H Lee Moffit Cancer Cnt And Res Inst
state: Florida
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Charlotte
country: United States
facility: Blumenthal Cancer Center, Carolinas Medical Center
state: North Carolina
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: