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Trial record 1 of 1 for:    ARD12166
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Cabazitaxel Compared to Topotecan for the Treatment of Small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT01500720
Recruitment Status : Completed
First Posted : December 28, 2011
Results First Posted : April 13, 2015
Last Update Posted : April 13, 2015
Sponsor:
Information provided by (Responsible Party):
Sanofi

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Small Cell Lung Cancer
Interventions Drug: Cabazitaxel
Drug: Topotecan
Enrollment 179
Recruitment Details  
Pre-assignment Details A total of 232 participants were screened of which 53 were screen failure and 179 were randomized.
Arm/Group Title Cabazitaxel Topotecan
Hide Arm/Group Description Cabazitaxel (XRP6258) 25 milligram per square meter (mg/m^2) intravenously (IV) on Day 1 every 3 weeks (21-day cycle) until unacceptable toxicity, disease progression or withdrawal consent. Topotecan 1.5 mg/m^2 IV on Day 1 to Day 5 every 3 weeks (21-Day cycle) until unacceptable toxicity, disease progression or withdrawal consent.
Period Title: Overall Study
Started 90 [1] 89 [1]
Treated 89 88
Completed 85 [2] 80 [2]
Not Completed 5 9
Reason Not Completed
Randomized But Not Treated             1             1
Other             4             8
[1]
Randomized
[2]
Cancer progression,adverse event,consent withdrawal are considered as completed(defined in protocol)
Arm/Group Title Cabazitaxel Topotecan Total
Hide Arm/Group Description Cabazitaxel 25 mg/m^2 IV on Day 1 every 3 weeks (21-day cycle) until unacceptable toxicity, disease progression or withdrawal consent. Topotecan 1.5 mg/m^2 IV on Day 1 to Day 5 every 3 weeks (21-Day cycle) until unacceptable toxicity, disease progression or withdrawal consent. Total of all reporting groups
Overall Number of Baseline Participants 90 89 179
Hide Baseline Analysis Population Description
Randomized population included all randomized participants, and was analyzed according to the randomized treatment.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 90 participants 89 participants 179 participants
59.9  (9.4) 61.6  (10.0) 60.7  (9.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 90 participants 89 participants 179 participants
Female
27
  30.0%
27
  30.3%
54
  30.2%
Male
63
  70.0%
62
  69.7%
125
  69.8%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 90 participants 89 participants 179 participants
Race: Caucasian/White 80 82 162
Race: Black 1 2 3
Race: Asian/Oriental 9 4 13
Race: Other 0 1 1
Ethnicity: Hispanic 4 3 7
Ethnicity: Not Hispanic 86 86 172
Eastern Cooperative Oncology Group (ECOG) Performance Status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 90 participants 89 participants 179 participants
0 31 17 48
1 59 71 130
2 0 1 1
[1]
Measure Description:

ECOG criteria:

  • 0: Fully active
  • 1: Ambulatory, carry out work of a light or sedentary nature
  • 2: Ambulatory, capable of all selfcare
  • 3: Capable of limited selfcare, confined to bed or chair more than 50% of waking hours
  • 4: Completely disabled, no selfcare, totally confined to bed or chair
  • 5: Dead
Primary Tumor Site  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 90 participants 89 participants 179 participants
Lungs 16 20 36
Right Lung 33 43 76
Left Lung 40 26 66
Other: Mediastino-Hilar 1 0 1
Stage at Diagnosis   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 90 participants 89 participants 179 participants
IIA 1 1 2
IIB 2 1 3
IIIA 2 12 14
IIIB 25 15 40
IV 57 55 112
Unknown 3 5 8
[1]
Measure Description: Disease stages were decided based on tumor size, lymph nodes and metastasis (as per National Comprehensive Cancer Network guidelines Version 2.2013).
Number of Organs Involved  
Mean (Standard Deviation)
Unit of measure:  Organs
Number Analyzed 90 participants 89 participants 179 participants
3.6  (1.3) 3.8  (1.4) 3.7  (1.3)
1.Primary Outcome
Title Progression Free Survival (PFS)
Hide Description PFS was defined as the time interval from the date of randomization to the date of occurrence of the first documented tumor progression or death due to any cause, whichever came first. Median PFS was estimated using the Kaplan-Meier method. Progression was defined using Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1) as: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study or unequivocal progression of existing non-target lesion. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). The appearance of one or more new lesions is also considered progression.
Time Frame Randomization to first tumor progression/clinical deterioration or death (maximum 7.6 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population included all randomized participants.
Arm/Group Title Cabazitaxel Topotecan
Hide Arm/Group Description:
Cabazitaxel 25 mg/m^2 IV on Day 1 every 3 weeks (21-day cycle) until unacceptable toxicity, disease progression or withdrawal consent.
Topotecan 1.5 mg/m^2 IV on Day 1 to Day 5 every 3 weeks (21-Day cycle) until unacceptable toxicity, disease progression or withdrawal consent.
Overall Number of Participants Analyzed 90 89
Median (95% Confidence Interval)
Unit of Measure: months
1.4
(1.4 to 1.5)
3.0
(2.7 to 4.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cabazitaxel, Topotecan
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value was calculated from stratified two-sided log-rank test, stratifying for brain metastases and lactate dehydrogenase (LDH) level at the time of randomization.
Method Stratified Two-Sided Log-Rank Test
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 2.169
Confidence Interval (2-Sided) 95%
1.563 to 3.01
Estimation Comments Hazard ratio was estimated using a COX Proportional Hazards regression model, stratifying for brain metastases and LDH level at the time of randomization.
2.Secondary Outcome
Title Overall Survival
Hide Description Overall survival was defined as the time interval from the date of randomization to the date of death due to any cause. In the absence of confirmation of death, survival time was to be censored at the last date the participant was known to be alive. Median time was estimated by Kaplan-Meier curve.
Time Frame From randomization to date of death (maximum 15 months)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title Cabazitaxel Topotecan
Hide Arm/Group Description:
Cabazitaxel 25 mg/m^2 IV on Day 1 every 3 weeks (21-day cycle) until unacceptable toxicity, disease progression or withdrawal consent.
Topotecan 1.5 mg/m^2 IV on Day 1 to Day 5 every 3 weeks (21-Day cycle) until unacceptable toxicity, disease progression or withdrawal consent.
Overall Number of Participants Analyzed 90 89
Median (95% Confidence Interval)
Unit of Measure: months
5.2
(3.38 to 6.11)
6.8
(5.03 to 8.08)
3.Secondary Outcome
Title Progression Free Rate at Week 12
Hide Description Progression was defined using Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1) as: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study or unequivocal progression of existing non-target lesion. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression. Death due to disease progression within 12 weeks without radiological documentation of progressive disease was counted as an event. Percentage of participants who were progression free at week 12 are reported.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title Cabazitaxel Topotecan
Hide Arm/Group Description:
Cabazitaxel 25 mg/m^2 IV on Day 1 every 3 weeks (21-day cycle) until unacceptable toxicity, disease progression or withdrawal consent.
Topotecan 1.5 mg/m^2 IV on Day 1 to Day 5 every 3 weeks (21-Day cycle) until unacceptable toxicity, disease progression or withdrawal consent.
Overall Number of Participants Analyzed 90 89
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
18.9
(11.4 to 28.5)
52.8
(41.9 to 63.5)
4.Secondary Outcome
Title Overall Objective Tumor Response Rate
Hide Description Overall objective tumor response was defined as the proportion of participants with confirmed RECIST 1.1 achieving a complete response (CR) or partial response (PR). CR was defined as disappearance of all target/non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Percentage of participants with overall objective tumor response is reported.
Time Frame Randomization to disease progression/occurrence (maximum 7.6 months)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title Cabazitaxel Topotecan
Hide Arm/Group Description:
Cabazitaxel 25 mg/m^2 IV on Day 1 every 3 weeks (21-day cycle) until unacceptable toxicity, disease progression or withdrawal consent.
Topotecan 1.5 mg/m^2 IV on Day 1 to Day 5 every 3 weeks (21-Day cycle) until unacceptable toxicity, disease progression or withdrawal consent.
Overall Number of Participants Analyzed 90 89
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0
(0.0 to 4.9)
10.1
(4.5 to 19.0)
Time Frame All Adverse Events (AE) were collected from signature of the informed consent form until 30 days after last study treatment administration (maximum 66 weeks) regardless of seriousness or relationship to investigational product.
Adverse Event Reporting Description Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the ‘on treatment period’ (from the first study treatment administration until 30 days after the last dose of study treatment). Safety population all randomized participants who received at least one dose of study medication (treated).
 
Arm/Group Title Cabazitaxel Topotecan
Hide Arm/Group Description Cabazitaxel 25 mg/m^2 IV on Day 1 every 3 weeks (21-day cycle) until unacceptable toxicity, disease progression or withdrawal consent. Topotecan 1.5 mg/m^2 IV on Day 1 to Day 5 every 3 weeks (21-Day cycle) until unacceptable toxicity, disease progression or withdrawal consent.
All-Cause Mortality
Cabazitaxel Topotecan
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Cabazitaxel Topotecan
Affected / at Risk (%) Affected / at Risk (%)
Total   36/89 (40.45%)   41/88 (46.59%) 
Blood and lymphatic system disorders     
Febrile neutropenia  1  6/89 (6.74%)  10/88 (11.36%) 
Neutropenia  1  2/89 (2.25%)  2/88 (2.27%) 
Anaemia  1  1/89 (1.12%)  6/88 (6.82%) 
Leukopenia  1  1/89 (1.12%)  1/88 (1.14%) 
Lymph node pain  1  1/89 (1.12%)  0/88 (0.00%) 
Thrombocytopenia  1  1/89 (1.12%)  10/88 (11.36%) 
Pancytopenia  1  0/89 (0.00%)  2/88 (2.27%) 
Cardiac disorders     
Pericardial effusion  1  2/89 (2.25%)  1/88 (1.14%) 
Cardiopulmonary failure  1  0/89 (0.00%)  2/88 (2.27%) 
Gastrointestinal disorders     
Abdominal pain  1  2/89 (2.25%)  0/88 (0.00%) 
Anal haemorrhage  1  1/89 (1.12%)  0/88 (0.00%) 
Diarrhoea  1  1/89 (1.12%)  0/88 (0.00%) 
Gastrointestinal pain  1  1/89 (1.12%)  0/88 (0.00%) 
Vomiting  1  1/89 (1.12%)  0/88 (0.00%) 
Anal fistula  1  0/89 (0.00%)  1/88 (1.14%) 
Duodenal ulcer haemorrhage  1  0/89 (0.00%)  1/88 (1.14%) 
General disorders     
Disease progression  1  6/89 (6.74%)  4/88 (4.55%) 
Asthenia  1  2/89 (2.25%)  2/88 (2.27%) 
Death  1  1/89 (1.12%)  0/88 (0.00%) 
Generalised oedema  1  1/89 (1.12%)  0/88 (0.00%) 
Performance status decreased  1  0/89 (0.00%)  1/88 (1.14%) 
Pyrexia  1  0/89 (0.00%)  1/88 (1.14%) 
Infections and infestations     
Neutropenic infection  1  4/89 (4.49%)  5/88 (5.68%) 
Neutropenic sepsis  1  3/89 (3.37%)  1/88 (1.14%) 
Bronchitis  1  1/89 (1.12%)  0/88 (0.00%) 
Clostridium difficile colitis  1  1/89 (1.12%)  0/88 (0.00%) 
Lung infection  1  1/89 (1.12%)  1/88 (1.14%) 
Pneumonia  1  1/89 (1.12%)  6/88 (6.82%) 
Postoperative wound infection  1  1/89 (1.12%)  0/88 (0.00%) 
Respiratory tract infection  1  1/89 (1.12%)  0/88 (0.00%) 
Injury, poisoning and procedural complications     
Craniocerebral injury  1  0/89 (0.00%)  1/88 (1.14%) 
Investigations     
White blood cell count decreased  1  1/89 (1.12%)  0/88 (0.00%) 
Blood creatinine increased  1  0/89 (0.00%)  1/88 (1.14%) 
Neutrophil count decreased  1  0/89 (0.00%)  1/88 (1.14%) 
Platelet count decreased  1  0/89 (0.00%)  2/88 (2.27%) 
Metabolism and nutrition disorders     
Hyponatraemia  1  3/89 (3.37%)  0/88 (0.00%) 
Hypokalaemia  1  1/89 (1.12%)  0/88 (0.00%) 
Dehydration  1  0/89 (0.00%)  1/88 (1.14%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  1/89 (1.12%)  0/88 (0.00%) 
Myalgia  1  1/89 (1.12%)  0/88 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Tumour pain  1  1/89 (1.12%)  0/88 (0.00%) 
Nervous system disorders     
Convulsion  1  1/89 (1.12%)  0/88 (0.00%) 
Epilepsy  1  1/89 (1.12%)  0/88 (0.00%) 
Paraparesis  1  1/89 (1.12%)  0/88 (0.00%) 
Sciatica  1  0/89 (0.00%)  1/88 (1.14%) 
Renal and urinary disorders     
Urinary retention  1  1/89 (1.12%)  0/88 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Pulmonary embolism  1  2/89 (2.25%)  1/88 (1.14%) 
Respiratory failure  1  2/89 (2.25%)  2/88 (2.27%) 
Acute respiratory failure  1  1/89 (1.12%)  0/88 (0.00%) 
Dyspnoea  1  1/89 (1.12%)  1/88 (1.14%) 
Haemoptysis  1  1/89 (1.12%)  0/88 (0.00%) 
Pleural effusion  1  1/89 (1.12%)  0/88 (0.00%) 
Pneumothorax  1  1/89 (1.12%)  0/88 (0.00%) 
Pulmonary haemorrhage  1  0/89 (0.00%)  1/88 (1.14%) 
Pulmonary microemboli  1  0/89 (0.00%)  1/88 (1.14%) 
Respiratory distress  1  0/89 (0.00%)  1/88 (1.14%) 
Skin and subcutaneous tissue disorders     
Cutaneous lupus erythematosus  1  0/89 (0.00%)  1/88 (1.14%) 
Dermatitis allergic  1  0/89 (0.00%)  1/88 (1.14%) 
Vascular disorders     
Hypotension  1  0/89 (0.00%)  1/88 (1.14%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cabazitaxel Topotecan
Affected / at Risk (%) Affected / at Risk (%)
Total   67/89 (75.28%)   75/88 (85.23%) 
Blood and lymphatic system disorders     
Anaemia  1  4/89 (4.49%)  18/88 (20.45%) 
Febrile neutropenia  1  4/89 (4.49%)  6/88 (6.82%) 
Leukopenia  1  1/89 (1.12%)  6/88 (6.82%) 
Neutropenia  1  2/89 (2.25%)  20/88 (22.73%) 
Thrombocytopenia  1  0/89 (0.00%)  14/88 (15.91%) 
Gastrointestinal disorders     
Abdominal pain  1  9/89 (10.11%)  3/88 (3.41%) 
Abdominal pain upper  1  5/89 (5.62%)  2/88 (2.27%) 
Constipation  1  8/89 (8.99%)  9/88 (10.23%) 
Diarrhoea  1  18/89 (20.22%)  9/88 (10.23%) 
Nausea  1  14/89 (15.73%)  11/88 (12.50%) 
Stomatitis  1  8/89 (8.99%)  3/88 (3.41%) 
Vomiting  1  15/89 (16.85%)  7/88 (7.95%) 
General disorders     
Asthenia  1  10/89 (11.24%)  17/88 (19.32%) 
Fatigue  1  26/89 (29.21%)  22/88 (25.00%) 
Non-cardiac chest pain  1  6/89 (6.74%)  6/88 (6.82%) 
Oedema peripheral  1  1/89 (1.12%)  5/88 (5.68%) 
Pyrexia  1  4/89 (4.49%)  7/88 (7.95%) 
Investigations     
Neutrophil count decreased  1  3/89 (3.37%)  6/88 (6.82%) 
Weight decreased  1  7/89 (7.87%)  4/88 (4.55%) 
Metabolism and nutrition disorders     
Decreased appetite  1  16/89 (17.98%)  13/88 (14.77%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  2/89 (2.25%)  6/88 (6.82%) 
Back pain  1  8/89 (8.99%)  5/88 (5.68%) 
Musculoskeletal pain  1  9/89 (10.11%)  5/88 (5.68%) 
Myalgia  1  5/89 (5.62%)  0/88 (0.00%) 
Pain in extremity  1  1/89 (1.12%)  6/88 (6.82%) 
Nervous system disorders     
Dizziness  1  2/89 (2.25%)  5/88 (5.68%) 
Headache  1  6/89 (6.74%)  9/88 (10.23%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  10/89 (11.24%)  8/88 (9.09%) 
Dyspnoea  1  9/89 (10.11%)  21/88 (23.86%) 
Skin and subcutaneous tissue disorders     
Alopecia  1  5/89 (5.62%)  5/88 (5.68%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.1
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.
If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.
Results Point of Contact
Name/Title: Trial Transparency Team
Organization: Sanofi
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01500720     History of Changes
Other Study ID Numbers: ARD12166
2011-003415-31 ( EudraCT Number )
U1111-1123-3503 ( Other Identifier: UTN )
First Submitted: December 22, 2011
First Posted: December 28, 2011
Results First Submitted: March 30, 2015
Results First Posted: April 13, 2015
Last Update Posted: April 13, 2015