Japanese Study of Ipilimumab Administered in Combination With Paclitaxel/Carboplatin in Patients With Nonsmall-cell Lung Cancer

Sponsor
Bristol-Myers Squibb
Study ID
NCT01165216
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ipilimumab, 3 mg — DRUG
    Intervenous (IV) injection, administered every 3 weeks for up to 6 cycles
  • Ipilimumab, 10 mg — DRUG
    IV injection, administered every 3 weeks for up to 6 cycles
  • Paclitaxel — DRUG
    IV injection, 175 mg/m\^2, administered every 3 weeks for up to 6 cycles
  • Carboplatin — DRUG
    IV injection, AUC=6, administered every 3 weeks for up to 6 cycles. (AUC=area under the concentration curve)

Study Details

The primary purpose of this study was to establish the recommended dose of ipilimumab administered in combination with paclitaxel and carboplatin in Japanese patients with nonsmall-cell lung cancer.

Key Dates

Start date
Sep 30, 2010
Status verified
Jun 2014
Primary completion
Jun 30, 2013
Completion
Jun 30, 2013

Study Design

Enrollment
15 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Level 1: Ipilimumab, 3 mg/kg + Paclitaxel + Carboplatin
    Participants received ipilimumab, 3 mg/kg, administered as a single dose intravenously (IV) over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m\^2 , administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses), and carboplatin, area under the curve (AUC)=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
  • Experimental: Dose Level 2: Ipilimumab, 10 mg/kg + Paclitaxel + Carboplatin
    Participants received ipilimumab, 10 mg/kg, administered as a single dose IV over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m\^2 , administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses), and carboplatin, AUC=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).

Primary Outcome Measure

Number of Participants Experiencing a Dose-limiting Toxicity (DLT) [ Time Frame: Day 1 of Cycles 1 and 2 From Day 1 of Cycle 3 to Day 21 of Cycle 4 ]

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