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BELotaxel(Docetaxel) and bellOXa(Oxaliplatin) in Advanced NSCLC (BELOXAN)

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ClinicalTrials.gov Identifier: NCT01243775
Recruitment Status : Completed
First Posted : November 19, 2010
Results First Posted : August 17, 2015
Last Update Posted : August 17, 2015
Sponsor:
Collaborator:
Chong Kun Dang Pharmaceutical
Information provided by (Responsible Party):
Young-Chul Kim, Chonnam National University Hospital

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Non-Small Cell Lung Cancer
Interventions Drug: Belotaxel
Drug: Belloxa
Enrollment 33
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Belotaxel Plus Belloxa
Hide Arm/Group Description Belotaxel 60 mg/m2 3 weekly (day 1) Belloxa 70 mg/m2 3 weekly (day 2)
Period Title: Overall Study
Started 33
Completed 31
Not Completed 2
Reason Not Completed
Withdrawal by Subject             2
Arm/Group Title Belotaxel Plus Belloxa
Hide Arm/Group Description Belotaxel 60 mg/m2 3 weekly (day 1) Belloxa 70 mg/m2 3 weekly (day 2)
Overall Number of Baseline Participants 33
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 33 participants
64.0  (9.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants
Female
3
   9.1%
Male
30
  90.9%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Korean Number Analyzed 33 participants
33
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Korea, Republic of Number Analyzed 33 participants
33
1.Primary Outcome
Title Response Rate
Hide Description RECIST version 1.1
Time Frame 6th week
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat population
Arm/Group Title Belotaxel Plus Belloxa
Hide Arm/Group Description:
Belotaxel 60 mg/m2 3 weekly (day 1) plus Belloxa 70 mg/m2 3 weekly (day 2)
Overall Number of Participants Analyzed 33
Measure Type: Number
Unit of Measure: participants
11
2.Secondary Outcome
Title Progression Free Survival
Hide Description [Not Specified]
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Belotaxel Plus Belloxa
Hide Arm/Group Description:
Belotaxel 60 mg/m2 3 weekly (day 1) plus Belloxa 70 mg/m2 3 weekly (day 2)
Overall Number of Participants Analyzed 33
Median (95% Confidence Interval)
Unit of Measure: months
3.6
(2.8 to 4.5)
3.Secondary Outcome
Title Overall Survival
Hide Description [Not Specified]
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Belotaxel Plus Belloxa
Hide Arm/Group Description:
Belotaxel 60 mg/m2 3 weekly (day 1) plus Belloxa 70 mg/m2 3 weekly (day 2)
Overall Number of Participants Analyzed 33
Median (95% Confidence Interval)
Unit of Measure: months
10.9
(8.2 to 13.6)
4.Secondary Outcome
Title Neutropenia Grade 3-4
Hide Description Toxicity (CECAE ver 4.0) and Safety
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Belotaxel Plus Belloxa
Hide Arm/Group Description:
Belotaxel 60 mg/m2 3 weekly (day 1) plus Belloxa 70 mg/m2 3 weekly (day 2)
Overall Number of Participants Analyzed 33
Measure Type: Number
Unit of Measure: participants
17
Time Frame 4 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Belotaxel Plus Belloxa
Hide Arm/Group Description Belotaxel 60 mg/m2 3 weekly (day 1) plus Belloxa 70 mg/m2 3 weekly (day 2)
All-Cause Mortality
Belotaxel Plus Belloxa
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Belotaxel Plus Belloxa
Affected / at Risk (%) # Events
Total   10/33 (30.30%)    
Blood and lymphatic system disorders   
Febrile Neutropenia * 1  2/33 (6.06%)  2
Infections and infestations   
Infection * 1  7/33 (21.21%)  7
Vascular disorders   
Thromboembolism * 1  1/33 (3.03%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Belotaxel Plus Belloxa
Affected / at Risk (%) # Events
Total   33/33 (100.00%)    
Gastrointestinal disorders   
Anorexia * 1  21/33 (63.64%) 
Diarrhea * 1  12/33 (36.36%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (4.0)
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
Layout table for Results Point of Contact information
Name/Title: Dr. Young-Chul Kim
Organization: Chonnam National University Hwasun Hospital
Phone: 82-61-379-7614
EMail: kyc0923@jnu.ac.kr
Layout table for additonal information
Responsible Party: Young-Chul Kim, Chonnam National University Hospital
ClinicalTrials.gov Identifier: NCT01243775     History of Changes
Other Study ID Numbers: m601NSC10B
First Submitted: November 15, 2010
First Posted: November 19, 2010
Results First Submitted: July 19, 2015
Results First Posted: August 17, 2015
Last Update Posted: August 17, 2015