ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01165216
Recruitment Status : Completed
First Posted : July 19, 2010
Results First Posted : July 22, 2014
Last Update Posted : July 22, 2014
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Non-Small Cell Lung Cancer
Interventions: Drug: Ipilimumab, 3 mg
Drug: Ipilimumab, 10 mg
Drug: Paclitaxel
Drug: Carboplatin

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants were enrolled in successive cohorts of 3 to 6 patients, using a standard 3+3 design. Of 15 patients enrolled, all received some treatment (chemotherapy or ipilimumab); 12 received at least 1 dose of ipilimumab.

Reporting Groups
  Description
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 concentration curve (AUC)=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
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).

Participant Flow:   Overall Study
    Dose Level 1: Ipilimumab, 3 mg/kg + Paclitaxel + Carboplatin   Dose Level 2: Ipilimumab, 10 mg/kg + Paclitaxel + Carboplatin
STARTED   8 [1]   7 [1] 
Received at Least 1 Dose of Ipilimumab   6   6 
COMPLETED   0 [2]   0 [2] 
NOT COMPLETED   8   7 
Adverse Event                6                3 
Withdrawal by Subject                1                1 
Disease progression                1                3 
[1] Participants who received any study drug
[2] Completed=still on study drug



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who received at least 1 dose of study drug.

Reporting Groups
  Description
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 concentration curve (AUC)=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
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).
Total Total of all reporting groups

Baseline Measures
   Dose Level 1: Ipilimumab, 3 mg/kg + Paclitaxel + Carboplatin   Dose Level 2: Ipilimumab, 10 mg/kg + Paclitaxel + Carboplatin   Total 
Overall Participants Analyzed 
[Units: Participants]
 8   7   15 
Age 
[Units: Years]
Mean (Standard Deviation)
 56.0  (12.62)   58.9  (10.25)   57.3  (11.26) 
Age, Customized 
[Units: Participants]
     
Younger than 65 years   7   4   11 
65 years and older   1   3   4 
Gender 
[Units: Participants]
     
Female   2   1   3 
Male   6   6   12 
Race/Ethnicity, Customized 
[Units: Participants]
     
Japanese   8   7   15 
Not reported   0   0   0 


  Outcome Measures

1.  Primary:   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 ]

2.  Secondary:   Number of Participants With Death As Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Drug-related Adverse Events (AEs), AEs Leading to Discontinuation, Drug-related AEs Leading to Discontinuation   [ Time Frame: Continuously from Day 1 to Week 24 and every12 weeks thereafter during maintenance until discontinuation of drug ]

3.  Secondary:   Number of Participants With Best Overall Response (BOR) of Partial Response (PR) or Stable Disease   [ Time Frame: Day 1 of Cycle 3, Day 1 of Cycle 5, and Day 22 of Cycle 6 ]

4.  Secondary:   Maximum Serum Concentration (Cmax) of Ipilimumab   [ Time Frame: During Cycle 3: predose and 1.5, 4, 24, 48, 168, and 336 hours postdose ipilimumab ]

5.  Secondary:   Trough Observed Serum Concentration (Cmin) of Ipilimumab   [ Time Frame: During Cycle 3: predose and 1.5, 4, 24, 48, 168, and 336 hours postdose ipilimumab ]

6.  Secondary:   Area Under the Concentration Curve From Time 0 to Day 21 (in 1 Interval Dosing) (AUC[0-21d]) for Ipilimumab   [ Time Frame: During Cycle 3: predose and 1.5, 4, 24, 48, 168, and 336 hours postdose ipilimumab ]

7.  Secondary:   Time of Maximum Observed Serum Concentration (Tmax)   [ Time Frame: During Cycle 3: predose and 1.5, 4, 24, 48, 168, and 336 hours postdose ipilimumab ]

8.  Secondary:   Serum Half-life (T-HALF) of Ipilimumab   [ Time Frame: During Cycle 3: predose and 1.5, 4, 24, 48, 168, and 336 hours postdose ipilimumab ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Bristol-Myers Squibb Study Director
Organization: Bristol-Myers Squibb
e-mail: Clinical.Trials@bms.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01165216     History of Changes
Other Study ID Numbers: CA184-113
First Submitted: July 16, 2010
First Posted: July 19, 2010
Results First Submitted: June 23, 2014
Results First Posted: July 22, 2014
Last Update Posted: July 22, 2014