Cabazitaxel Compared to Topotecan for the Treatment of Small Cell Lung Cancer

• Sponsor: Sanofi (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01500720
• Collaborator: (none)
• Enrollment: 179
• Locations: 58
• Arms: 2
• Duration (Months): 25
• Patients Per Site: 3.1
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

Primary Objective:

To demonstrate progression free survival (PFS) improvement for cabazitaxel compared to topotecan in participants with sensitive or resistant/refractory small cell lung cancer following a first line platinum based chemotherapy.

Secondary Objectives:

• To assess disease progression free rate at 12 weeks

• To assess Response Rate (Response Evaluation Criteria in Solid Tumor [RECIST] 1.1) and duration of response

• To assess Overall Survival (OS)

• To assess the Safety (National Cancer Institute - Common Toxicity Criteria [NCI-CTC] version 4.03)

• To assess the Health-Related Quality of Life (HRQoL)

Condition or Disease	Intervention/Treatment	Phase
Small Cell Lung Cancer	Drug: Cabazitaxel; Drug: Topotecan	Phase 2

Detailed Description

Participants are to be treated until progressive disease, unacceptable toxicity or refusal for further study treatment.

All participants are to be followed for disease progression documentation and for participant status until the study cut-off date.

Study Design

• Study Type: Interventional
• Actual Enrollment: 179 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Randomized Phase II Study of Cabazitaxel Versus Topotecan in Small Cell Lung Cancer Patients With Progressive Disease During or After a First Line Platinum Based Chemotherapy
• Study Start Date: Mar 1, 2012
• Actual Primary Completion Date: Apr 1, 2014
• Actual Study Completion Date: Apr 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cabazitaxel	Drug: Cabazitaxel; Cabazitaxel 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.; Other Names: XRP6258
Active Comparator: Topotecan	Drug: Topotecan; 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.

Outcome Measures

Primary Outcome Measures

1. Progression Free Survival (PFS) [Randomization to first tumor progression/clinical deterioration or death (maximum 7.6 months)]

   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.

Secondary Outcome Measures

1. Overall Survival [From randomization to date of death (maximum 15 months)]

   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.

2. Progression Free Rate at Week 12 [Week 12]

   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.

3. Overall Objective Tumor Response Rate [Randomization to disease progression/occurrence (maximum 7.6 months)]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion criteria :

• Histological/cytological proven locally advanced or metastatic small cell lung cancer with progressive disease during or after first line platinum based chemotherapy

• Male or female greater than or equal to (>=) 18 years (or country's legal age of majority if greater than [>]18 years)

• Participants with measurable disease, Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1)

• Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to (<=) 1

Exclusion criteria:

• Absence of signed and dated Institutional Review Board (IRB)-approved participant informed consent form prior to enrollment into the study

• More than one prior chemotherapy regimen. Prior treatment with topotecan or taxanes

• Less than 28 days elapsed from prior treatment with chemotherapy, radiotherapy or surgery to the time of randomization (Radiotherapy for bone pain palliation is allowed)

• Adverse events (excluding alopecia) from any prior anticancer therapy of grade >1 (National Cancer Institute Common Terminology Criteria [NCI CTCAE] v4.03) at the time of randomization

• Uncontrolled Central Nervous System (CNS) metastases: participants with CNS metastases may have previous irradiation, only participants with stable disease or response to irradiation who are without CNS symptoms and on a maximum steroid dose of dexamethasone 8 mg daily or equivalent could be included

• Participants with known leptomeningeal metastases

• History of other, invasive neoplasm requiring ongoing therapy

• Participation in another clinical trial and any concurrent treatment with any investigational drug within 30 days prior to randomization

• Any of the following within 6 months prior to study enrollment: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, New York Heart Association class III or IV congestive heart failure, stroke or transient ischemic attack

• Any severe acute or chronic medical condition, which could impair the ability of the participant to participate in the study or interfere with interpretation of study results

• Known Human Immunodeficiency Virus (HIV) disease, or active hepatitis B or C (systematic testing was not required)

• Pregnant or breast-feeding woman. Positive serum or urine pregnancy test prior to randomization

• Participant with reproductive potential (M/F) who did not agree to use an accepted and effective method of contraception during the study treatment period and for at least 6 months after the completion of the study treatment. The definition of "effective method of contraception" was based on the investigator's judgment. Effective method of contraception should also be adapted to local regulation

• History of hypersensitivity to polysorbate 80

• Inadequate organ and bone marrow function as evidenced by:

• Hemoglobin less than [<] 9.0 gram per deciliter (g/dL)

• Absolute neutrophil count <1.5 x 10^9 per liter

• Platelet count <100 x 10^9 per liter

• Aspartate Aminotransferase/Serum Glutamic Oxaloacetic Transaminase (AST/SGOT) and/or alanine aminotransferase/Serum Glutamic-Pyruvic Transaminase (ALT/SGPT)

2.5 x Upper Limit of Normal (ULN)

• Alkaline Phosphatase (AP) >2.5 x ULN. In case of liver metastases AP >5 x ULN

• Total bilirubin >1.0 x ULN

• Serum Creatinine >1.5 x ULN. If creatinine 1.0 - 1.5 x ULN, creatinine clearance will be calculated according to Chronic Kidney Disease Epidemiology Collaboration formula, and creatinine clearance <60 milliliter per minute (mL/min) was exclude the participant.

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Investigational Site Number 840007	Muscle Shoals	Alabama	United States	35661
2	Investigational Site Number 840005	Omaha	Nebraska	United States	68114
3	Investigational Site Number 840006	Lebanon	New Hampshire	United States	03756
4	Investigational Site Number 840003	Middletown	Ohio	United States	45042
5	Investigational Site Number 840001	Philadelphia	Pennsylvania	United States	19104
6	Investigational Site Number 076001	Porto Alegre		Brazil	90610-000
7	Investigational Site Number 124003	Montreal		Canada	H3T 1E2
8	Investigational Site Number 124002	Oshawa		Canada	L1G 2B9
9	Investigational Site Number 124004	Rimouski		Canada	G5L 5T1
10	Investigational Site Number 124001	Toronto		Canada	M5G 2M9
11	Investigational Site Number 152001	Santiago		Chile	8380456
12	Investigational Site Number 152005	Santiago		Chile
13	Investigational Site Number 250005	Brest		France	29609
14	Investigational Site Number 250004	Caen Cedex		France	14033
15	Investigational Site Number 250006	La Tronche		France	38700
16	Investigational Site Number 250002	Lille		France	59800
17	Investigational Site Number 250003	Saint-Herblain Cedex		France	44805
18	Investigational Site Number 250007	Villejuif Cedex		France	94805
19	Investigational Site Number 276003	Großhansdorf		Germany	22927
20	Investigational Site Number 276006	Löwenstein		Germany	74245
21	Investigational Site Number 300005	Athens		Greece	11522
22	Investigational Site Number 300003	Athens		Greece	11527
23	Investigational Site Number 300001	Heraklion		Greece	71110
24	Investigational Site Number 300002	Thessaloniki		Greece	54629
25	Investigational Site Number 300004	Thessaloniki		Greece	57010
26	Investigational Site Number 348001	Budapest		Hungary	1121
27	Investigational Site Number 348004	Budapest		Hungary	1121
28	Investigational Site Number 348002	Budapest		Hungary	1125
29	Investigational Site Number 348003	Törökbálint		Hungary	2045
30	Investigational Site Number 380001	Genova		Italy	16132
31	Investigational Site Number 380002	Livorno		Italy	57123
32	Investigational Site Number 380005	Novara		Italy	28100
33	Investigational Site Number 380004	Parma		Italy	43100
34	Investigational Site Number 410001	Seoul		Korea, Republic of	120-752
35	Investigational Site Number 410003	Seoul		Korea, Republic of	135-710
36	Investigational Site Number 410002	Seoul		Korea, Republic of	138-736
37	Investigational Site Number 578001	Oslo		Norway	0440
38	Investigational Site Number 578003	Stavanger		Norway	4011
39	Investigational Site Number 578002	Trondheim		Norway	7006
40	Investigational Site Number 616004	Gdansk		Poland	80-952
41	Investigational Site Number 616003	Lublin		Poland	20-954
42	Investigational Site Number 616002	Poznan		Poland	60-569
43	Investigational Site Number 616001	Warszawa		Poland	02-781
44	Investigational Site Number 642003	Cluj Napoca		Romania	400015
45	Investigational Site Number 642005	Cluj-Napoca		Romania	400015
46	Investigational Site Number 642001	Craiova		Romania	200385
47	Investigational Site Number 642002	Timisoara		Romania
48	Investigational Site Number 643001	Moscow		Russian Federation	115478
49	Investigational Site Number 643005	St-Petersburg		Russian Federation	197758
50	Investigational Site Number 643006	Tula		Russian Federation	300053
51	Investigational Site Number 643003	Yaroslavl		Russian Federation	150054
52	Investigational Site Number 724002	Badalona		Spain	08916
53	Investigational Site Number 724004	Barcelona		Spain	08035
54	Investigational Site Number 724005	Málaga		Spain	29010
55	Investigational Site Number 724001	Valencia		Spain	46026
56	Investigational Site Number 804002	Dnipropetrovsk		Ukraine	49102
57	Investigational Site Number 804004	Donetsk		Ukraine	83092
58	Investigational Site Number 804001	Lviv		Ukraine	70031

Sponsors and Collaborators

• Sanofi

Investigators

• Study Director: Clinical Sciences & Operations, Sanofi

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sanofi
• ClinicalTrials.gov Identifier: NCT01500720
• Other Study ID Numbers: ARD12166; 2011-003415-31; U1111-1123-3503
• First Posted: Dec 28, 2011
• Last Update Posted: Apr 13, 2015
• Last Verified: Mar 1, 2015

• Additional relevant MeSH terms: Lung Neoplasms; Small Cell Lung Carcinoma; Topotecan

Study Results

Participant Flow

Pre-assignment Detail	A total of 232 participants were screened of which 53 were screen failure and 179 were randomized.

Arm/Group Title	Cabazitaxel	Topotecan
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	89
Treated	89	88
COMPLETED	85	80
NOT COMPLETED	5	9

Baseline Characteristics

Arm/Group Title	Cabazitaxel	Topotecan	Total
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 Participants	90	89	179
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	59.9 (9.4)	61.6 (10.0)	60.7 (9.7)
Sex: Female, Male (Count of Participants)
Female	27 30%	27 30.3%	54 30.2%
Male	63 70%	62 69.7%	125 69.8%
Race/Ethnicity, Customized (participants) [Number]
Race: Caucasian/White	80 88.9%	82 92.1%	162 90.5%
Race: Black	1 1.1%	2 2.2%	3 1.7%
Race: Asian/Oriental	9 10%	4 4.5%	13 7.3%
Race: Other	0 0%	1 1.1%	1 0.6%
Ethnicity: Hispanic	4 4.4%	3 3.4%	7 3.9%
Ethnicity: Not Hispanic	86 95.6%	86 96.6%	172 96.1%
Eastern Cooperative Oncology Group (ECOG) Performance Status (participants) [Number]
0	31 34.4%	17 19.1%	48 26.8%
1	59 65.6%	71 79.8%	130 72.6%
2	0 0%	1 1.1%	1 0.6%
Primary Tumor Site (participants) [Number]
Lungs	16 17.8%	20 22.5%	36 20.1%
Right Lung	33 36.7%	43 48.3%	76 42.5%
Left Lung	40 44.4%	26 29.2%	66 36.9%
Other: Mediastino-Hilar	1 1.1%	0 0%	1 0.6%
Stage at Diagnosis (participants) [Number]
IIA	1 1.1%	1 1.1%	2 1.1%
IIB	2 2.2%	1 1.1%	3 1.7%
IIIA	2 2.2%	12 13.5%	14 7.8%
IIIB	25 27.8%	15 16.9%	40 22.3%
IV	57 63.3%	55 61.8%	112 62.6%
Unknown	3 3.3%	5 5.6%	8 4.5%
Number of Organs Involved (organs) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [organs]	3.6 (1.3)	3.8 (1.4)	3.7 (1.3)

Outcome Measures

1. Primary Outcome

Title	Progression Free Survival (PFS)
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)

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population included all randomized participants.

Arm/Group Title	Cabazitaxel	Topotecan
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.
Measure Participants	90	89
Median (95% Confidence Interval) [months]	1.4	3.0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cabazitaxel, Topotecan
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
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
Method of Estimation	Estimation Parameter	Cox Proportional Hazard
	Estimated Value	2.169
	Confidence Interval	(2-Sided) 95%; 1.563 to 3.01
	Parameter Dispersion	Type: Value:
	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
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)

Outcome Measure Data

Analysis Population Description

ITT population.

Arm/Group Title	Cabazitaxel	Topotecan
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.
Measure Participants	90	89
Median (95% Confidence Interval) [months]	5.2	6.8

3. Secondary Outcome

Title	Progression Free Rate at Week 12
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

Outcome Measure Data

Analysis Population Description

ITT population.

Arm/Group Title	Cabazitaxel	Topotecan
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.
Measure Participants	90	89
Number (95% Confidence Interval) [percentage of participants]	18.9 21%	52.8 59.3%

4. Secondary Outcome

Title	Overall Objective Tumor Response Rate
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)

Outcome Measure Data

Analysis Population Description

ITT population.

Arm/Group Title	Cabazitaxel	Topotecan
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.
Measure Participants	90	89
Number (95% Confidence Interval) [percentage of participants]	0 0%	10.1 11.3%

Adverse Events

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
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Cabazitaxel		Topotecan
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	36/89 (40.4%)		41/88 (46.6%)
Blood and lymphatic system disorders
Febrile neutropenia	6/89 (6.7%)		10/88 (11.4%)
Neutropenia	2/89 (2.2%)		2/88 (2.3%)
Anaemia	1/89 (1.1%)		6/88 (6.8%)
Leukopenia	1/89 (1.1%)		1/88 (1.1%)
Lymph node pain	1/89 (1.1%)		0/88 (0%)
Thrombocytopenia	1/89 (1.1%)		10/88 (11.4%)
Pancytopenia	0/89 (0%)		2/88 (2.3%)
Cardiac disorders
Pericardial effusion	2/89 (2.2%)		1/88 (1.1%)
Cardiopulmonary failure	0/89 (0%)		2/88 (2.3%)
Gastrointestinal disorders
Abdominal pain	2/89 (2.2%)		0/88 (0%)
Anal haemorrhage	1/89 (1.1%)		0/88 (0%)
Diarrhoea	1/89 (1.1%)		0/88 (0%)
Gastrointestinal pain	1/89 (1.1%)		0/88 (0%)
Vomiting	1/89 (1.1%)		0/88 (0%)
Anal fistula	0/89 (0%)		1/88 (1.1%)
Duodenal ulcer haemorrhage	0/89 (0%)		1/88 (1.1%)
General disorders
Disease progression	6/89 (6.7%)		4/88 (4.5%)
Asthenia	2/89 (2.2%)		2/88 (2.3%)
Death	1/89 (1.1%)		0/88 (0%)
Generalised oedema	1/89 (1.1%)		0/88 (0%)
Performance status decreased	0/89 (0%)		1/88 (1.1%)
Pyrexia	0/89 (0%)		1/88 (1.1%)
Infections and infestations
Neutropenic infection	4/89 (4.5%)		5/88 (5.7%)
Neutropenic sepsis	3/89 (3.4%)		1/88 (1.1%)
Bronchitis	1/89 (1.1%)		0/88 (0%)
Clostridium difficile colitis	1/89 (1.1%)		0/88 (0%)
Lung infection	1/89 (1.1%)		1/88 (1.1%)
Pneumonia	1/89 (1.1%)		6/88 (6.8%)
Postoperative wound infection	1/89 (1.1%)		0/88 (0%)
Respiratory tract infection	1/89 (1.1%)		0/88 (0%)
Injury, poisoning and procedural complications
Craniocerebral injury	0/89 (0%)		1/88 (1.1%)
Investigations
White blood cell count decreased	1/89 (1.1%)		0/88 (0%)
Blood creatinine increased	0/89 (0%)		1/88 (1.1%)
Neutrophil count decreased	0/89 (0%)		1/88 (1.1%)
Platelet count decreased	0/89 (0%)		2/88 (2.3%)
Metabolism and nutrition disorders
Hyponatraemia	3/89 (3.4%)		0/88 (0%)
Hypokalaemia	1/89 (1.1%)		0/88 (0%)
Dehydration	0/89 (0%)		1/88 (1.1%)
Musculoskeletal and connective tissue disorders
Back pain	1/89 (1.1%)		0/88 (0%)
Myalgia	1/89 (1.1%)		0/88 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain	1/89 (1.1%)		0/88 (0%)
Nervous system disorders
Convulsion	1/89 (1.1%)		0/88 (0%)
Epilepsy	1/89 (1.1%)		0/88 (0%)
Paraparesis	1/89 (1.1%)		0/88 (0%)
Sciatica	0/89 (0%)		1/88 (1.1%)
Renal and urinary disorders
Urinary retention	1/89 (1.1%)		0/88 (0%)
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism	2/89 (2.2%)		1/88 (1.1%)
Respiratory failure	2/89 (2.2%)		2/88 (2.3%)
Acute respiratory failure	1/89 (1.1%)		0/88 (0%)
Dyspnoea	1/89 (1.1%)		1/88 (1.1%)
Haemoptysis	1/89 (1.1%)		0/88 (0%)
Pleural effusion	1/89 (1.1%)		0/88 (0%)
Pneumothorax	1/89 (1.1%)		0/88 (0%)
Pulmonary haemorrhage	0/89 (0%)		1/88 (1.1%)
Pulmonary microemboli	0/89 (0%)		1/88 (1.1%)
Respiratory distress	0/89 (0%)		1/88 (1.1%)
Skin and subcutaneous tissue disorders
Cutaneous lupus erythematosus	0/89 (0%)		1/88 (1.1%)
Dermatitis allergic	0/89 (0%)		1/88 (1.1%)
Vascular disorders
Hypotension	0/89 (0%)		1/88 (1.1%)
Other (Not Including Serious) Adverse Events
	Cabazitaxel		Topotecan
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	67/89 (75.3%)		75/88 (85.2%)
Blood and lymphatic system disorders
Anaemia	4/89 (4.5%)		18/88 (20.5%)
Febrile neutropenia	4/89 (4.5%)		6/88 (6.8%)
Leukopenia	1/89 (1.1%)		6/88 (6.8%)
Neutropenia	2/89 (2.2%)		20/88 (22.7%)
Thrombocytopenia	0/89 (0%)		14/88 (15.9%)
Gastrointestinal disorders
Abdominal pain	9/89 (10.1%)		3/88 (3.4%)
Abdominal pain upper	5/89 (5.6%)		2/88 (2.3%)
Constipation	8/89 (9%)		9/88 (10.2%)
Diarrhoea	18/89 (20.2%)		9/88 (10.2%)
Nausea	14/89 (15.7%)		11/88 (12.5%)
Stomatitis	8/89 (9%)		3/88 (3.4%)
Vomiting	15/89 (16.9%)		7/88 (8%)
General disorders
Asthenia	10/89 (11.2%)		17/88 (19.3%)
Fatigue	26/89 (29.2%)		22/88 (25%)
Non-cardiac chest pain	6/89 (6.7%)		6/88 (6.8%)
Oedema peripheral	1/89 (1.1%)		5/88 (5.7%)
Pyrexia	4/89 (4.5%)		7/88 (8%)
Investigations
Neutrophil count decreased	3/89 (3.4%)		6/88 (6.8%)
Weight decreased	7/89 (7.9%)		4/88 (4.5%)
Metabolism and nutrition disorders
Decreased appetite	16/89 (18%)		13/88 (14.8%)
Musculoskeletal and connective tissue disorders
Arthralgia	2/89 (2.2%)		6/88 (6.8%)
Back pain	8/89 (9%)		5/88 (5.7%)
Musculoskeletal pain	9/89 (10.1%)		5/88 (5.7%)
Myalgia	5/89 (5.6%)		0/88 (0%)
Pain in extremity	1/89 (1.1%)		6/88 (6.8%)
Nervous system disorders
Dizziness	2/89 (2.2%)		5/88 (5.7%)
Headache	6/89 (6.7%)		9/88 (10.2%)
Respiratory, thoracic and mediastinal disorders
Cough	10/89 (11.2%)		8/88 (9.1%)
Dyspnoea	9/89 (10.1%)		21/88 (23.9%)
Skin and subcutaneous tissue disorders
Alopecia	5/89 (5.6%)		5/88 (5.7%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.