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Triplet Combination First Line Treatment in Non Small Cell Lung Cancer (NSCLC) (CBP08-02)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00942825
First Posted: July 21, 2009
Last Update Posted: May 24, 2017
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.
Information provided by (Responsible Party):
CanBas Co. Ltd.
Results First Submitted: March 14, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Metastatic Non-squamous Non Small Cell Lung Cancer
Interventions: Drug: CBP501 + Cisplatin + Pemetrexed
Drug: Cisplatin + Pemetrexed

  Participant Flow
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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
No text entered.

Reporting Groups
  Description
A CBP501 +Cisplatin + Pemetrexed

CBP501 25 mg/m2 + Cisplatin 75 mg/m2 + Pemetrexed 500mg/m2

CBP501 + Cisplatin + Pemetrexed: CBP501, pemetrexed and cisplatin will be administered on the same day (Day 1), every 3 weeks for a maximum of six cycles. A cycle is considered to be 3 weeks (21 days).

  1. CBP501 25 mg/m² will be administered as an i.v. infusion of 1 hour.
  2. Pemetrexed 500 mg/m² will be administered as an i.v. infusion over 10 minutes, immediately after the CBP501 infusion.
  3. Cisplatin 75 mg/m² will be administered as a 1-hour i.v. infusion immediately after the pemetrexed infusion.
B Cisplatin + Pemetrexed

Cisplatin + Pemetrexed

Cisplatin + Pemetrexed: Pemetrexed and cisplatin will be administered on the same day (Day 1), every 3 weeks for a maximum of six cycles. A cycle is considered to be 3 weeks (21 days).

  1. Pemetrexed 500 mg/m² will be administered as an i.v. infusion over 10 minutes.
  2. Cisplatin 75 mg/m² will be administered as a 1-hour i.v. infusion immediately after the pemetrexed infusion.

Participant Flow:   Overall Study
    A CBP501 +Cisplatin + Pemetrexed   B Cisplatin + Pemetrexed
STARTED   97   98 
COMPLETED   97   98 
NOT COMPLETED   0   0 



  Baseline Characteristics
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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.
No text entered.

Reporting Groups
  Description
A CBP501 +Cisplatin + Pemetrexed

CBP501 25 mg/m2 + Cisplatin 75 mg/m2 + Pemetrexed 500mg/m2

CBP501 + Cisplatin + Pemetrexed: CBP501, pemetrexed and cisplatin will be administered on the same day (Day 1), every 3 weeks for a maximum of six cycles. A cycle is considered to be 3 weeks (21 days).

  1. CBP501 25 mg/m² will be administered as an i.v. infusion of 1 hour.
  2. Pemetrexed 500 mg/m² will be administered as an i.v. infusion over 10 minutes, immediately after the CBP501 infusion.
  3. Cisplatin 75 mg/m² will be administered as a 1-hour i.v. infusion immediately after the pemetrexed infusion.
B Cisplatin + Pemetrexed

Cisplatin + Pemetrexed

Cisplatin + Pemetrexed: Pemetrexed and cisplatin will be administered on the same day (Day 1), every 3 weeks for a maximum of six cycles. A cycle is considered to be 3 weeks (21 days).

  1. Pemetrexed 500 mg/m² will be administered as an i.v. infusion over 10 minutes.
  2. Cisplatin 75 mg/m² will be administered as a 1-hour i.v. infusion immediately after the pemetrexed infusion.
Total Total of all reporting groups

Baseline Measures
   A CBP501 +Cisplatin + Pemetrexed   B Cisplatin + Pemetrexed   Total 
Overall Participants Analyzed 
[Units: Participants]
 97   98   195 
Age 
[Units: Years]
Mean (Standard Deviation)
 60.5  (8.66)   60.6  (9.03)   60.6  (8.82) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      51  52.6%      36  36.7%      87  44.6% 
Male      46  47.4%      62  63.3%      108  55.4% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      6   6.2%      1   1.0%      7   3.6% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      3   3.1%      3   3.1%      6   3.1% 
White      75  77.3%      88  89.8%      163  83.6% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      13  13.4%      6   6.1%      19   9.7% 


  Outcome Measures

1.  Primary:   The Primary Efficacy Endpoint is Progression Free Survival, Analyzed in the Treated Population. PFS is Assessed From Randomization Until Either Tumor Progression, as Per RECIST Criteria, or Until Death Due to Any Reason.   [ Time Frame: 15 June 2009 to 30 September 2012 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Takumi Kawabe, MD, PhD
Organization: CanBas Co., Ltd.
phone: 81559543666
e-mail: takumi@canbas.co.jp


Publications:


Responsible Party: CanBas Co. Ltd.
ClinicalTrials.gov Identifier: NCT00942825     History of Changes
Other Study ID Numbers: CBP08-02
First Submitted: July 17, 2009
First Posted: July 21, 2009
Results First Submitted: March 14, 2017
Results First Posted: May 24, 2017
Last Update Posted: May 24, 2017



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