Japanese Study of Ipilimumab Administered in Combination With Paclitaxel/Carboplatin in Patients With Nonsmall-cell Lung Cancer
NCT01165216 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15
Last updated 2014-07-22
Summary
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.
Conditions
Interventions
- DRUG
-
Ipilimumab, 3 mg
Intervenous (IV) injection, administered every 3 weeks for up to 6 cycles
- DRUG
-
Ipilimumab, 10 mg
IV injection, administered every 3 weeks for up to 6 cycles
- DRUG
-
IV injection, 175 mg/m\^2, administered every 3 weeks for up to 6 cycles
- DRUG
-
IV injection, AUC=6, administered every 3 weeks for up to 6 cycles. (AUC=area under the concentration curve)
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Bristol-Myers Squibb · Bristol-Myers Squibb
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 20 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2010-09-30
- Primary Completion
- 2013-06-30
- Completion
- 2013-06-30
Countries
- Japan
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