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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-022163-35 | EudraCT Number |
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Primary Objective:
- To demonstrate the non inferiority in term of overall survival (OS) of Cabazitaxel 20 mg/m² (Arm A) versus Cabazitaxel 25 mg/m² (Arm B) in combination with prednisone in participants with metastatic castration resistant prostate cancer (mCRPC) previously treated with a docetaxel-containing regimen.
Secondary Objectives:
To evaluate safety in the 2 treatment arms and to assess if Cabazitaxel 20 mg/m² was better tolerated than Cabazitaxel 25 mg/m².
To compare efficacy of Cabazitaxel at 20 mg/m² and 25 mg/m² for:
To compare Health-related Quality of Life (HRQoL).
To assess the pharmacokinetics and pharmacogenomics of Cabazitaxel.
Participants were treated until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles. All participants were followed when on study treatment and after completion of study treatment during follow up period until death or the study cutoff date, whichever came first.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cabazitaxel 20 mg/m^2 | Experimental | Cabazitaxel 20 mg/m^2 intravenous (IV) infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until disease progression (DP), unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles. |
|
| Cabazitaxel 25 mg/m^2 | Experimental | Cabazitaxel 25 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cabazitaxel (XRP6258) | Drug | Pharmaceutical form: Concentrate and solvent for solution for infusion Route of administration: Intravenous |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS was defined as the time interval from the date of randomization to the date of death due to any cause. In absence of confirmation of death, survival time was censored at the earlier of the last date the participant was known to be alive or the study cut-off date. The cut-off date for the final analysis of OS was the date when the 988th death had been observed. Analysis was performed by Kaplan-Meier method. | From baseline up to death due to any cause or study cut-off date, whichever was earlier (maximum duration: 48 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | PFS was evaluated from date of randomization to date of first documentation of any of the events: 1) Radiological tumor progression: as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1: at least a 20% increase in sum of diameters of target lesions (sum must also demonstrate an absolute increase of ≥5 mm) taking as reference the smallest sum while on study, appearance of one or more new lesions, or unequivocal progression of existing non target lesions, 2) Prostate Specific Antigen (PSA) progression: ≥25% increase over baseline/nadir value if baseline PSA ≥10 ng/mL; or 25% increase above the baseline level if baseline PSA >0 ng/mL & <10 ng/mL; or post-baseline value of >=2 ng/mL, if baseline PSA=0 ng/mL, 3) Pain progression: increase of ≥1 point in median Present Pain Intensity (PPI) from nadir or ≥25% increase in mean analgesic score (AS) from baseline score or requirement of local palliative radiotherapy, 4) Death. Analysis was performed by Kaplan-Meier method. |
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Inclusion criteria :
I 01. Diagnosis of histologically or cytologically proven prostate adenocarcinoma, that was resistant to hormone therapy and previously treated with a docetaxel-containing regimen.
I 02. Participant must had either measurable or non-measurable disease. I 03. Received prior castration by orchiectomy and/or Luteinizing Hormone-Releasing Hormone (LH-RH) agonist with or without antiandrogen, antiandrogen withdrawal, monotherapy with estramustine, or other hormonal agents.
I 04. Life expectancy > 6 months. I 05. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 - 2 (i.e, participant must be ambulatory, capable of all self-care, and up and about more than 50% of waking hours).
I 06. Age ≥18 years (or country's legal age of majority if the legal age was > 18 years).
Exclusion criteria:
E 01. Previous treatment with mitoxantrone or cabazitaxel. E 02. Prior isotope therapy or radiotherapy to ≥30% of bone marrow. In case of prior isotope therapy 12 weeks must had elapsed prior to first study drug administration.
E 03. Adverse events (excluding alopecia and those listed in the specific exclusion criteria) from any prior anticancer therapy of grade >1(National Cancer Institute Common Terminology Criteria [NCI CTCAE] v4.03) at the time of randomization.
E 04. Prior surgery, radiation, chemotherapy, or other anti-cancer therapy within 4 weeks prior to enrollment in the study.
E 05. Prior malignancy. Adequately treated basal cell or squamous cell skin or superficial (pTis, pTa, and pT1) bladder cancer were allowed, as well as any other cancer for which chemotherapy had been completed ≥ 5 years ago and from which the participant had been disease-free for ≥ 5 years.
E 06. Participation in another clinical trial and any concurrent treatment with any investigational drug within 30 days prior to randomization.
E 07. Known brain or leptomeningeal involvement. E 08. Other concurrent serious illness or medical conditions. E 09. Uncontrolled cardiac arrhythmias, angina pectoris, and/or hypertension. History of congestive heart failure (NYHA III or IV) or myocardial infarction within last 6 months was also not allowed.
E 10. Any severe acute or chronic medical condition which could impair the ability of the participant to participate to the study or to comply with the study procedures or interfere with interpretation of study results.
E 11. Absence of signed and dated Institutional Review Board (IRB)-approved participant informed consent form prior to enrollment into the study.
E 12. Participants with reproductive potential who did not agree to use accepted and effective method of contraception during the study treatment period. The definition of "effective method of contraception" was based on the Investigator's judgment. Participant's Partners of childbearing potential (unless surgically sterile, post menopausal or for another reason had no chance of becoming pregnant) not protected by highly effective contraceptive method of birth control as defined for contraception in the Informed Consent Form and /or in a local protocol addendum.
E 13. History of hypersensitivity to docetaxel, or polysorbate 80. E 14. Inadequate organ and bone marrow function. E 15. Contraindications to the use of corticosteroid treatment. E 16. Symptomatic peripheral neuropathy grade > 2 (NCI CTCAE v.4.03).
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site Number 840002 | Muscle Shoals | Alabama | 35661 | United States | ||
| Investigational Site Number 840004 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42020286 | Derived | Vauchier C, Thibault C, Velev M, Becker O, Guillaume Z, Ashton E, Zaibet S, Berthou H, Courtinat F, Gervais C, Rochand A, Robbrecht D, Oudard S, Auclin E. Integrated Prognostic Score in Metastatic Castration-resistant Prostate Cancer Treated with Cabazitaxel - A CABASTY Post Hoc Analysis Validated by Two International Prospective Phase 3 Trials. Eur Urol Oncol. 2026 Apr 21:S2588-9311(26)00081-7. doi: 10.1016/j.euo.2026.03.022. Online ahead of print. | |
| 35677318 |
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Participants were randomized by Interactive Voice Response System (IVRS) in 1:1 ratio (Cabazitaxel 20 mg/m^2: Cabazitaxel 25 mg/m^2) and stratified according to Eastern Cooperative Oncology Group Performance Status (ECOG PS) score (0 or 1 versus 2), measurability of disease (measurable versus non-measurable) and region.
The study was conducted at 172 centers in 22 countries. A total of 1463 participants were screened between 19 April 2011 and 18 November 2013. Out of 1463 participants, 1200 participants were enrolled in this study and 263 were not eligible to join the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cabazitaxel 20 mg/m^2 | Cabazitaxel 20 mg/m^2 intravenous (IV) infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until disease progression (DP), unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Prednisone (or Prednisolone) | Drug | Pharmaceutical form: Tablet Route of administration: Oral |
|
| From baseline up to tumor progression, PSA progression, pain progression, death due to any cause or study cut-off date, whichever was earlier (maximum duration: 48 months) |
| Time to Tumor Progression | Time to Tumor progression was defined as the first occurrence of radiological tumor progression according to RECIST 1.1. Radiological tumor progression was defined at least a 20% increase in sum of diameters of target lesions (sum must also demonstrate an absolute increase of ≥5 mm) taking as reference the smallest sum while on study, appearance of one or more new lesions, or unequivocal progression of existing non target-lesions. Analysis was performed by Kaplan-Meier method. | From baseline up to tumor progression or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 48 months) |
| Percentage of Participants With Overall Objective Tumor Response | Overall objective tumor response was defined as either a partial response (PR) or complete response (CR) according to the RECIST 1.1 criteria, as assessed by the investigator. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must had 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. | From baseline up to DP or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 48 months) |
| Time to PSA Progression | Time to PSA progression was time interval between randomization & first occurrence of PSA progression. PSA progression defined as: 1) PSA responders (>50% decline from baseline PSA ≥10 ng/mL): increase of ≥25% (≥2 ng/mL) over nadir value, confirmed by second PSA ≥3 weeks later; 2) PSA non-responders (did not achieve >50% decline from baseline PSA ≥10 ng/mL): increase of ≥25% (≥2 ng/mL) over baseline value, confirmed by second PSA ≥3 weeks later; 3) In participants not eligible for PSA response (baseline PSA <10 ng/mL): (a) participants with baseline PSA >0 ng/mL & <10 ng/mL: increase in PSA by 25% (≥2 ng/mL) above baseline level, confirmed by second PSA value ≥3 weeks apart; (b) participants with baseline value=0 ng/mL: post-baseline PSA value ≥2 ng/mL. Note (for 1-3): Rise in PSA in first 12 weeks was progression only if met definition above and was associated with other sign of DP or if it continued beyond 12 weeks. Analysis was performed by Kaplan-Meier method. | From baseline up to PSA progression or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 48 months) |
| Percentage of Participants With PSA Response | PSA response was defined as ≥50% decrease from baseline in serum PSA levels, confirmed by a second PSA value at least 3 weeks later in participants with baseline PSA value ≥10 ng/mL. | From baseline up to PSA progression or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 48 months) |
| Time to Pain Progression | Pain Progression was defined as an increase of ≥1 point in the median PPI from its nadir confirmed by a second assessment at least 3 weeks later or ≥25 % increase in the mean AS compared with the baseline score confirmed by a second assessment at least 3 weeks later or requirement for local palliative radiotherapy. PPI was rated by participant in a diary using a scale of 0=no pain, 1=mild, 2=discomforting, 3=distressing, 4=horrible 5=excruciating. Analgesic use was recorded by the participant in a diary. AS was calculated from the analgesic use data based on a table of analgesic medications, with non-narcotic medications assigned a value of 1 point and narcotic medications assigned a value of 4 points. Analysis was performed by Kaplan-Meier method. | From baseline until DP, start of another anti-cancer therapy, death or study cut-off date (maximum duration: 48 months) |
| Percentage of Participants With Pain Response | Pain response was defined as either a ≥2-point decrease from baseline median PPI score without increase in AS, or a ≥50% decrease from baseline mean AS without increase in the PPI score, maintained for 2 consecutive evaluations at least 3 weeks apart. Increases in pain during the first 12 weeks were ignored in determining pain response. | From baseline until DP, start of another anti-cancer therapy, death or study cut-off date (maximum duration: 48 months) |
| Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P):Trial Outcome Index (TOI) as a Measure of Health Related Quality of Life (HRQoL) | FACT-P is a 39-item participant questionnaire that measures the concerns of participants with prostate cancer. It consists of 5 sub-scales assessing physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and prostate-specific concerns (12 items). FACT-P TOI combines physical well-being, functional well-being, and prostate-specific concerns sub-scales for a total possible score range of 0 to 104, where higher values represent better HRQoL. | Baseline, Day 1 of each Cycle 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 (each cycle 21-day); post-treatment follow up 1 (up to 12 weeks) |
| Change From Baseline in FACT-P:Total Score as a Measure of HRQoL | FACT-P is a 39-item participant questionnaire that measures the concerns of participants with prostate cancer. It consists of 5 sub-scales assessing physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and prostate-specific concerns (12 items). FACT-P Total Score sums all 5 sub-scales to give a score in the range of 0 to 156, where higher values represent better HRQoL. | Baseline, Day 1 of each Cycle 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 (each cycle 21-day); post-treatment follow up 1 (up to 12 weeks) |
| Percentage of Participants With FACT-P Total Score Response | FACT-P is a 39-item participant questionnaire that measures the concerns of participants with prostate cancer. It consists of 5 sub-scales assessing physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and prostate-specific concerns (12 items). FACT-P Total Score sums all 5 sub-scales to give a score in the range of 0 to 156, where higher values represent better HRQoL. Responder of FACT-P was defined as at least one occurrence of 7-point improvement from baseline in FACT-P total score during treatment period. | From baseline until DP, start of another anti-cancer therapy, death or study cut-off date (maximum duration: 48 months) |
| Time to Definitive Deterioration of Score by 10% From Baseline on FACT-P Sub-Scales | The time to definitive deterioration (10% decrease in score from baseline) was assessed for the individual sub-scales (Physical Well-Being; Social/Family Well-Being; Emotional Well-Being; Functional Well-Being; Prostate-Specific Concerns). Analysis was performed by Kaplan-Meier method. | From baseline until DP, start of another anti-cancer therapy, death or study cut-off date (maximum duration: 48 months) |
| Time to Definitive Deterioration of ECOG PS Score From Baseline | The ECOG PS was used to evaluate participant's DP and the effect of the disease on the participant's activities of daily living. It ranges on the scale from 0-5 (0= normal activity; 1= symptoms but ambulatory; 2= in bed for < 50 % of the time; 3= in bed for > 50% of the time; 4= 100% bedridden; 5= dead). Time to definitive deterioration in ECOG PS score from baseline was defined as a change from 0, 1 to ≥2, or from 2 to ≥3. Analysis was performed by Kaplan-Meier method. | From baseline until death or study cut-off date (maximum duration: 48 months) |
| Time to Definitive Weight Loss by 5% and 10% From Baseline | Time to definitive weight loss was defined as the time to first occurrence of ≥5% or ≥10% decrease in body weight from baseline. Analysis was performed by Kaplan-Meier method. | From baseline until death or study cut-off date (maximum duration: 48 months) |
| Time to First Definitive Consumption of Narcotic Medication | Concomitant medications used were recorded for all participants, and time of first definitive consumption of narcotic medication (if it occurred) was determined. This measure summarizes the time from baseline to first definitive consumption of narcotic medication. Analysis was performed by Kaplan-Meier method. | From baseline until DP, start of another anti-cancer therapy, death or study cut-off date (maximum duration: 48 months) |
| Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) | Any untoward medical occurrence in a participant who received investigational medicinal product (IMP) was considered an adverse event (AE) without regard to possibility of causal relationship with this treatment. TEAEs: AEs that developed or worsened or became serious during on-treatment period. On-treatment period: The time from the first dose of treatment to 30 days after the last dose of treatment (either Cabazitaxel or Prednisone). A serious adverse event: Any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs. National Cancer Institute Common Terminology Criteria (NCI-CTCAE) version 4.03 (Grade 3 [severe] and Grade 4 [life-threatening]) was used in this study to grade clinical AEs. | From first administration of study treatment until 30 days after the last administration of study treatment (Maximum duration: 48 months) |
| Plasma Clearance (CL) for Cabazitaxel | Blood samples for pharmacokinetic (PK) analysis were obtained from a subset of the study participants (approximately 150 participants/group, by protocol) according to a sparse sampling strategy. | Day 1 of Cycle 1: 5 minutes before the end of infusion (EOI), 15 minutes, 1 to 4 hour, 6 to 24 hours, 48 to 168 hour after EOI |
| Plasma Steady State Volume of Distribution (Vss) for Cabazitaxel | Blood samples for PK analysis were obtained from a subset of the study participants (approximately 150 participants/group, by protocol) according to a sparse sampling strategy. | Day 1 of Cycle 1: 5 minutes before the EOI, 15 minutes, 1 to 4 hour, 6 to 24 hours, 48 to 168 hour after EOI |
| Hot Springs |
| Arkansas |
| 71913 |
| United States |
| Investigational Site Number 840008 | Anaheim | California | 92801 | United States |
| Investigational Site Number 840010 | La Jolla | California | 92093 | United States |
| Investigational Site Number 840001 | San Bernardino | California | 92404 | United States |
| Investigational Site Number 840021 | Stamford | Connecticut | 06902 | United States |
| Investigational Site Number 840023 | Jacksonville | Florida | 32256 | United States |
| Investigational Site Number 840013 | Lakeland | Florida | 33805 | United States |
| Investigational Site Number 840003 | Port Saint Lucie | Florida | 34952 | United States |
| Investigational Site Number 840007 | New Orleans | Louisiana | 70112 | United States |
| Investigational Site Number 840014 | Baltimore | Maryland | 21231 | United States |
| Investigational Site Number 840005 | Rockville | Maryland | 20850 | United States |
| Investigational Site Number 840017 | Saint Louis Park | Minnesota | 55416 | United States |
| Investigational Site Number 840011 | Jackson | Mississippi | 39202 | United States |
| Investigational Site Number 840016 | Lincoln | Nebraska | 68506 | United States |
| Investigational Site Number 840015 | East Orange | New Jersey | 07018 | United States |
| Investigational Site Number 840024 | Raleigh | North Carolina | 27607 | United States |
| Investigational Site Number 840020 | Akron | Ohio | 44302 | United States |
| Investigational Site Number 840006 | Pawtucket | Rhode Island | 02860 | United States |
| Investigational Site Number 840025 | Chattanooga | Tennessee | 37421 | United States |
| Investigational Site Number 840012 | Corpus Christi | Texas | 78405 | United States |
| Investigational Site Number 032002 | Buenos Aires | C1120AAT | Argentina |
| Investigational Site Number 032001 | Rosario | 2000 | Argentina |
| Investigational Site Number 032003 | Salta | A4406CLA | Argentina |
| Investigational Site Number 032004 | Santa Fe | 3000 | Argentina |
| Investigational Site Number 036014 | Adelaide | 5000 | Australia |
| Investigational Site Number 036013 | Bankstown | 2200 | Australia |
| Investigational Site Number 036010 | Box Hill | 3128 | Australia |
| Investigational Site Number 036012 | Camperdown | 2050 | Australia |
| Investigational Site Number 036008 | Coffs Harbour | 2450 | Australia |
| Investigational Site Number 036001 | Concord | 2137 | Australia |
| Investigational Site Number 036015 | Elizabeth Vale | 5112 | Australia |
| Investigational Site Number 036009 | Fitzroy | 3065 | Australia |
| Investigational Site Number 036007 | Garran | 2605 | Australia |
| Investigational Site Number 036005 | Heidelberg West | 3081 | Australia |
| Investigational Site Number 036002 | Malvern | 3144 | Australia |
| Investigational Site Number 036006 | South Brisbane | 4101 | Australia |
| Investigational Site Number 036016 | Subiaco | 6008 | Australia |
| Investigational Site Number 036003 | Wahroonga | 2076 | Australia |
| Investigational Site Number 036004 | Wodonga | 3690 | Australia |
| Investigational Site Number 056007 | Antwerp | B-2020 | Belgium |
| Investigational Site Number 056001 | Brussels | 1000 | Belgium |
| Investigational Site Number 056008 | Brussels | 1090 | Belgium |
| Investigational Site Number 056002 | Brussels | 1200 | Belgium |
| Investigational Site Number 056009 | Charleroi | B-6000 | Belgium |
| Investigational Site Number 056003 | Ghent | 9000 | Belgium |
| Investigational Site Number 056012 | Godinne | B-5530 | Belgium |
| Investigational Site Number 056016 | Haine-Saint-Paul | 7100 | Belgium |
| Investigational Site Number 056005 | Hasselt | B-3500 | Belgium |
| Investigational Site Number 056010 | Libramont | 6800 | Belgium |
| Investigational Site Number 056013 | Liège | 4000 | Belgium |
| Investigational Site Number 056011 | Ottignies | 1340 | Belgium |
| Investigational Site Number 056004 | Roeselare | 8800 | Belgium |
| Investigational Site Number 056006 | Turnhout | B-2300 | Belgium |
| Investigational Site Number 076016 | Fortaleza | Brazil |
| Investigational Site Number 076012 | Ijuí | 98700 000 | Brazil |
| Investigational Site Number 076015 | Mogi das Cruzes | 08730-500 | Brazil |
| Investigational Site Number 076014 | Porto Alegre | 90110-270 | Brazil |
| Investigational Site Number 076010 | Rio de Janeiro | 22793-080 | Brazil |
| Investigational Site Number 076007 | Salvador | 41256-900 | Brazil |
| Investigational Site Number 076003 | São José do Rio Preto | 15090-000 | Brazil |
| Investigational Site Number 076009 | São Paulo | 01221-020 | Brazil |
| Investigational Site Number 076001 | São Paulo | 01308050 | Brazil |
| Investigational Site Number 076013 | São Paulo | 01321-001 | Brazil |
| Investigational Site Number 076008 | São Paulo | 01509-900 | Brazil |
| Investigational Site Number 076002 | São Paulo | 03102-002 | Brazil |
| Investigational Site Number 124002 | Greenfield Park | J4V 2H1 | Canada |
| Investigational Site Number 124001 | Oshawa | L1G 2B9 | Canada |
| Investigational Site Number 124003 | Ottawa | K1H 8L6 | Canada |
| Investigational Site Number 124005 | Owen Sound | N4K 2J1 | Canada |
| Investigational Site Number 152005 | Santiago | 751-0009 | Chile |
| Investigational Site Number 152004 | Santiago | 7510032 | Chile |
| Investigational Site Number 152002 | Santiago | 8380456 | Chile |
| Investigational Site Number 152001 | Viña del Mar | 2540364 | Chile |
| Investigational Site Number 250005 | Avignon | 84918 | France |
| Investigational Site Number 250008 | Hyères | 83400 | France |
| Investigational Site Number 250001 | La Roche-sur-Yon | 85925 | France |
| Investigational Site Number 250002 | Nantes | 44202 | France |
| Investigational Site Number 250004 | Nîmes | 30029 | France |
| Investigational Site Number 250010 | Paris | 75014 | France |
| Investigational Site Number 250009 | Reims | 51056 | France |
| Investigational Site Number 250007 | Reims | 51100 | France |
| Investigational Site Number 250006 | Saint-Brieuc | 22015 | France |
| Investigational Site Number 250003 | Toulouse | 31052 | France |
| Investigational Site Number 250011 | Toulouse | 31076 | France |
| Investigational Site Number 276003 | Aachen | 52074 | Germany |
| Investigational Site Number 276007 | Dresden | 01307 | Germany |
| Investigational Site Number 276004 | Düsseldorf | 40225 | Germany |
| Investigational Site Number 276001 | Erlangen | 91054 | Germany |
| Investigational Site Number 276011 | Hamburg | 20246 | Germany |
| Investigational Site Number 276005 | Hamburg | 22399 | Germany |
| Investigational Site Number 276010 | Homburg | 66421 | Germany |
| Investigational Site Number 276006 | München | 81675 | Germany |
| Investigational Site Number 276012 | Nürtingen | 72622 | Germany |
| Investigational Site Number 276008 | Tübingen | 72076 | Germany |
| Investigational Site Number 276002 | Wuppertal | 42103 | Germany |
| Investigational Site Number 348001 | Budapest | 1122 | Hungary |
| Investigational Site Number 348005 | Budapest | 1134 | Hungary |
| Investigational Site Number 348004 | Budapest | 1145 | Hungary |
| Investigational Site Number 348006 | Miskolc | 3526 | Hungary |
| Investigational Site Number 348003 | Pécs | 7624 | Hungary |
| Investigational Site Number 528005 | Arnhem | 6815 AD | Netherlands |
| Investigational Site Number 528003 | Blaricum | 1261 AN | Netherlands |
| Investigational Site Number 528004 | Hoofddorp | 2134 TM | Netherlands |
| Investigational Site Number 528002 | Nijmegen | 6525 GA | Netherlands |
| Investigational Site Number 528001 | Zwolle | 8025 AB | Netherlands |
| Investigational Site Number 604003 | Arequipa | 5154 | Peru |
| Investigational Site Number 604006 | Lima | 027 | Peru |
| Investigational Site Number 604001 | Lima | 041 | Peru |
| Investigational Site Number 604007 | Lima | LIM27 | Peru |
| Investigational Site Number 604002 | Lima | Lima -41 | Peru |
| Investigational Site Number 604004 | Lima | LIMA 01 | Peru |
| Investigational Site Number 604005 | Lima | Lima 41 | Peru |
| Investigational Site Number 616006 | Lubin | 59-300 | Poland |
| Investigational Site Number 616002 | Olsztyn | 10-228 | Poland |
| Investigational Site Number 616001 | Rybnik | 44-200 | Poland |
| Investigational Site Number 616005 | Siedlce | 08-110 | Poland |
| Investigational Site Number 616004 | Torun | 87-100 | Poland |
| Investigational Site Number 642005 | Alba Iulia | 510077 | Romania |
| Investigational Site Number 642006 | Baia Mare | 430031 | Romania |
| Investigational Site Number 642009 | Bucharest | 010976 | Romania |
| Investigational Site Number 642008 | Bucharest | 022328 | Romania |
| Investigational Site Number 642001 | Cluj-Napoca | 400015 | Romania |
| Investigational Site Number 642003 | Cluj-Napoca | 400015 | Romania |
| Investigational Site Number 642004 | Cluj-Napoca | 400015 | Romania |
| Investigational Site Number 642002 | Cluj-Napoca | 400058 | Romania |
| Investigational Site Number 642012 | Focşani | 620034 | Romania |
| Investigational Site Number 642007 | Hunedoara | 331057 | Romania |
| Investigational Site Number 642013 | Onești | 601048 | Romania |
| Investigational Site Number 643007 | Moscow | 105425 | Russia |
| Investigational Site Number 643005 | Moscow | 115478 | Russia |
| Investigational Site Number 643004 | Moscow | 117997 | Russia |
| Investigational Site Number 643006 | Moscow | 125284 | Russia |
| Investigational Site Number 643008 | Obninsk | 249036 | Russia |
| Investigational Site Number 643001 | Saint Petersburg | 197022 | Russia |
| Investigational Site Number 643010 | Saint Petersburg | 197758 | Russia |
| Investigational Site Number 643003 | Tula | 300053 | Russia |
| Investigational Site Number 643009 | Yekaterinburg | 620036 | Russia |
| Investigational Site Number 710003 | Cape Town | 7570 | South Africa |
| Investigational Site Number 710002 | Durban | 4001 | South Africa |
| Investigational Site Number 710005 | Johannesburg | 2193 | South Africa |
| Investigational Site Number 710004 | Johannesburg | 2196 | South Africa |
| Investigational Site Number 710001 | Pretoria | 0001 | South Africa |
| Investigational Site Number 410003 | Seongnam | 463-707 | South Korea |
| Investigational Site Number 410002 | Seoul | 110-744 | South Korea |
| Investigational Site Number 410004 | Seoul | 120-752 | South Korea |
| Investigational Site Number 410005 | Seoul | 135-710 | South Korea |
| Investigational Site Number 410001 | Seoul | 138-736 | South Korea |
| Investigational Site Number 724003 | Badalona | 08916 | Spain |
| Investigational Site Number 724001 | Barcelona | 08035 | Spain |
| Investigational Site Number 724002 | Madrid | 28033 | Spain |
| Investigational Site Number 724008 | Madrid | 28050 | Spain |
| Investigational Site Number 724006 | Málaga | 29010 | Spain |
| Investigational Site Number 724005 | Palma de Mallorca | 07010 | Spain |
| Investigational Site Number 724004 | Sabadell | 08208 | Spain |
| Investigational Site Number 724007 | Seville | 41071 | Spain |
| Investigational Site Number 158002 | Taiching | 40447 | Taiwan |
| Investigational Site Number 158003 | Tainan | 704 | Taiwan |
| Investigational Site Number 158001 | Taipei | 100 | Taiwan |
| Investigational Site Number 788004 | Sfax | 3029 | Tunisia |
| Investigational Site Number 788003 | Sousse | 4000 | Tunisia |
| Investigational Site Number 788002 | Tunis | 1006 | Tunisia |
| Investigational Site Number 792003 | Antalya | 07059 | Turkey (Türkiye) |
| Investigational Site Number 792001 | Bornova | 35100 | Turkey (Türkiye) |
| Investigational Site Number 792002 | Istanbul | 34093 | Turkey (Türkiye) |
| Investigational Site Number 826002 | Birmingham | B18 7QH | United Kingdom |
| Investigational Site Number 826004 | Colchester | CO3 3NB | United Kingdom |
| Investigational Site Number 826005 | Glasgow | G11 6NT | United Kingdom |
| Investigational Site Number 826006 | Guildford | GU2 7XX | United Kingdom |
| Investigational Site Number 826007 | Manchester | M20 4BX | United Kingdom |
| Investigational Site Number 826003 | Newcastle upon Tyne | NE7 7DN | United Kingdom |
| Investigational Site Number 826001 | Sutton | SM2 5PT | United Kingdom |
| Derived |
| Meisel A, de Wit R, Oudard S, Sartor O, Stenner-Liewen F, Shun Z, Foster M, Ozatilgan A, Eisenberger M, de Bono JS. Neutropenia, neutrophilia, and neutrophil-lymphocyte ratio as prognostic markers in patients with metastatic castration-resistant prostate cancer. Ther Adv Med Oncol. 2022 Jun 1;14:17588359221100022. doi: 10.1177/17588359221100022. eCollection 2022. |
| 33740734 | Derived | Thiery-Vuillemin A, Fizazi K, Sartor O, Oudard S, Bury D, Thangavelu K, Ozatilgan A, Poole EM, Eisenberger M, de Bono J. An analysis of health-related quality of life in the phase III PROSELICA and FIRSTANA studies assessing cabazitaxel in patients with metastatic castration-resistant prostate cancer. ESMO Open. 2021 Apr;6(2):100089. doi: 10.1016/j.esmoop.2021.100089. Epub 2021 Mar 16. |
| 29500065 | Derived | Mehra N, Dolling D, Sumanasuriya S, Christova R, Pope L, Carreira S, Seed G, Yuan W, Goodall J, Hall E, Flohr P, Boysen G, Bianchini D, Sartor O, Eisenberger MA, Fizazi K, Oudard S, Chadjaa M, Mace S, de Bono JS. Plasma Cell-free DNA Concentration and Outcomes from Taxane Therapy in Metastatic Castration-resistant Prostate Cancer from Two Phase III Trials (FIRSTANA and PROSELICA). Eur Urol. 2018 Sep;74(3):283-291. doi: 10.1016/j.eururo.2018.02.013. Epub 2018 Feb 28. |
| 28809610 | Derived | Eisenberger M, Hardy-Bessard AC, Kim CS, Geczi L, Ford D, Mourey L, Carles J, Parente P, Font A, Kacso G, Chadjaa M, Zhang W, Bernard J, de Bono J. Phase III Study Comparing a Reduced Dose of Cabazitaxel (20 mg/m2) and the Currently Approved Dose (25 mg/m2) in Postdocetaxel Patients With Metastatic Castration-Resistant Prostate Cancer-PROSELICA. J Clin Oncol. 2017 Oct 1;35(28):3198-3206. doi: 10.1200/JCO.2016.72.1076. Epub 2017 Aug 15. |
| 23228299 | Derived | Winquist E, Rodrigues G. Open clinical uro-oncology trials in Canada. Can J Urol. 2012 Dec;19(6):6587-91. No abstract available. |
| Cabazitaxel 25 mg/m^2 |
Cabazitaxel 25 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles. |
| Treated |
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| COMPLETED |
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| NOT COMPLETED |
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Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cabazitaxel 20 mg/m^2 | Cabazitaxel 20 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles. |
| BG001 | Cabazitaxel 25 mg/m^2 | Cabazitaxel 25 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Overall Survival (OS) | OS was defined as the time interval from the date of randomization to the date of death due to any cause. In absence of confirmation of death, survival time was censored at the earlier of the last date the participant was known to be alive or the study cut-off date. The cut-off date for the final analysis of OS was the date when the 988th death had been observed. Analysis was performed by Kaplan-Meier method. | Analysis was performed on Intent-to-Treat (ITT) population, which included all randomized participants. | Posted | Median | 95% Confidence Interval | months | From baseline up to death due to any cause or study cut-off date, whichever was earlier (maximum duration: 48 months) |
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| Secondary | Progression Free Survival (PFS) | PFS was evaluated from date of randomization to date of first documentation of any of the events: 1) Radiological tumor progression: as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1: at least a 20% increase in sum of diameters of target lesions (sum must also demonstrate an absolute increase of ≥5 mm) taking as reference the smallest sum while on study, appearance of one or more new lesions, or unequivocal progression of existing non target lesions, 2) Prostate Specific Antigen (PSA) progression: ≥25% increase over baseline/nadir value if baseline PSA ≥10 ng/mL; or 25% increase above the baseline level if baseline PSA >0 ng/mL & <10 ng/mL; or post-baseline value of >=2 ng/mL, if baseline PSA=0 ng/mL, 3) Pain progression: increase of ≥1 point in median Present Pain Intensity (PPI) from nadir or ≥25% increase in mean analgesic score (AS) from baseline score or requirement of local palliative radiotherapy, 4) Death. Analysis was performed by Kaplan-Meier method. | Analysis was performed on ITT population. | Posted | Median | 95% Confidence Interval | months | From baseline up to tumor progression, PSA progression, pain progression, death due to any cause or study cut-off date, whichever was earlier (maximum duration: 48 months) |
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| Secondary | Time to Tumor Progression | Time to Tumor progression was defined as the first occurrence of radiological tumor progression according to RECIST 1.1. Radiological tumor progression was defined at least a 20% increase in sum of diameters of target lesions (sum must also demonstrate an absolute increase of ≥5 mm) taking as reference the smallest sum while on study, appearance of one or more new lesions, or unequivocal progression of existing non target-lesions. Analysis was performed by Kaplan-Meier method. | Analysis was performed on ITT population. | Posted | Median | 95% Confidence Interval | months | From baseline up to tumor progression or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 48 months) |
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| Secondary | Percentage of Participants With Overall Objective Tumor Response | Overall objective tumor response was defined as either a partial response (PR) or complete response (CR) according to the RECIST 1.1 criteria, as assessed by the investigator. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must had 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. | Analysis was performed on ITT population. Number of participants analyzed= participants evaluable for tumor response with measurable disease at baseline and at least one valid post-baseline value. | Posted | Number | 95% Confidence Interval | percentage of participants | From baseline up to DP or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 48 months) |
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| Secondary | Time to PSA Progression | Time to PSA progression was time interval between randomization & first occurrence of PSA progression. PSA progression defined as: 1) PSA responders (>50% decline from baseline PSA ≥10 ng/mL): increase of ≥25% (≥2 ng/mL) over nadir value, confirmed by second PSA ≥3 weeks later; 2) PSA non-responders (did not achieve >50% decline from baseline PSA ≥10 ng/mL): increase of ≥25% (≥2 ng/mL) over baseline value, confirmed by second PSA ≥3 weeks later; 3) In participants not eligible for PSA response (baseline PSA <10 ng/mL): (a) participants with baseline PSA >0 ng/mL & <10 ng/mL: increase in PSA by 25% (≥2 ng/mL) above baseline level, confirmed by second PSA value ≥3 weeks apart; (b) participants with baseline value=0 ng/mL: post-baseline PSA value ≥2 ng/mL. Note (for 1-3): Rise in PSA in first 12 weeks was progression only if met definition above and was associated with other sign of DP or if it continued beyond 12 weeks. Analysis was performed by Kaplan-Meier method. | Analysis was performed on ITT population. | Posted | Median | 95% Confidence Interval | months | From baseline up to PSA progression or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 48 months) |
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| Secondary | Percentage of Participants With PSA Response | PSA response was defined as ≥50% decrease from baseline in serum PSA levels, confirmed by a second PSA value at least 3 weeks later in participants with baseline PSA value ≥10 ng/mL. | Analysis was performed on ITT population. Number of participants analyzed= participants evaluable for PSA response with PSA value ≥10 ng/mL at baseline and at least one valid post-baseline value. | Posted | Number | 95% Confidence Interval | percentage of participants | From baseline up to PSA progression or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 48 months) |
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| Secondary | Time to Pain Progression | Pain Progression was defined as an increase of ≥1 point in the median PPI from its nadir confirmed by a second assessment at least 3 weeks later or ≥25 % increase in the mean AS compared with the baseline score confirmed by a second assessment at least 3 weeks later or requirement for local palliative radiotherapy. PPI was rated by participant in a diary using a scale of 0=no pain, 1=mild, 2=discomforting, 3=distressing, 4=horrible 5=excruciating. Analgesic use was recorded by the participant in a diary. AS was calculated from the analgesic use data based on a table of analgesic medications, with non-narcotic medications assigned a value of 1 point and narcotic medications assigned a value of 4 points. Analysis was performed by Kaplan-Meier method. | Analysis was performed on ITT population. | Posted | Median | 95% Confidence Interval | months | From baseline until DP, start of another anti-cancer therapy, death or study cut-off date (maximum duration: 48 months) |
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| Secondary | Percentage of Participants With Pain Response | Pain response was defined as either a ≥2-point decrease from baseline median PPI score without increase in AS, or a ≥50% decrease from baseline mean AS without increase in the PPI score, maintained for 2 consecutive evaluations at least 3 weeks apart. Increases in pain during the first 12 weeks were ignored in determining pain response. | Analysis was performed on ITT population. Number of participants analyzed= participants evaluable for pain response with pain score with median PPI ≥2 and/or mean AS ≥10 points at baseline and at least one valid post-baseline value. | Posted | Number | 95% Confidence Interval | percentage of participants | From baseline until DP, start of another anti-cancer therapy, death or study cut-off date (maximum duration: 48 months) |
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| Secondary | Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P):Trial Outcome Index (TOI) as a Measure of Health Related Quality of Life (HRQoL) | FACT-P is a 39-item participant questionnaire that measures the concerns of participants with prostate cancer. It consists of 5 sub-scales assessing physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and prostate-specific concerns (12 items). FACT-P TOI combines physical well-being, functional well-being, and prostate-specific concerns sub-scales for a total possible score range of 0 to 104, where higher values represent better HRQoL. | FACT-P population included randomized participants who completed FACT-P questionnaire at baseline & in at least one post-baseline assessment. Number of participants analyzed=participants with evaluable FACT-P TOI for specified outcome measure. Here, 'n' signifies number of participants with available data for specified category. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline, Day 1 of each Cycle 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 (each cycle 21-day); post-treatment follow up 1 (up to 12 weeks) |
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| Secondary | Change From Baseline in FACT-P:Total Score as a Measure of HRQoL | FACT-P is a 39-item participant questionnaire that measures the concerns of participants with prostate cancer. It consists of 5 sub-scales assessing physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and prostate-specific concerns (12 items). FACT-P Total Score sums all 5 sub-scales to give a score in the range of 0 to 156, where higher values represent better HRQoL. | Analysis was performed on FACT-P population. Number of participants analyzed=participants with evaluable FACT-P Total Score for specified outcome measure. Here, 'n' signifies number of participants with available data for specified category. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline, Day 1 of each Cycle 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 (each cycle 21-day); post-treatment follow up 1 (up to 12 weeks) |
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| Secondary | Percentage of Participants With FACT-P Total Score Response | FACT-P is a 39-item participant questionnaire that measures the concerns of participants with prostate cancer. It consists of 5 sub-scales assessing physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and prostate-specific concerns (12 items). FACT-P Total Score sums all 5 sub-scales to give a score in the range of 0 to 156, where higher values represent better HRQoL. Responder of FACT-P was defined as at least one occurrence of 7-point improvement from baseline in FACT-P total score during treatment period. | Analysis was performed on FACT-P population. Number of participants analyzed= participants with evaluable FACT-P total score for specified outcome measure. | Posted | Number | 95% Confidence Interval | percentage of participants | From baseline until DP, start of another anti-cancer therapy, death or study cut-off date (maximum duration: 48 months) |
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| Secondary | Time to Definitive Deterioration of Score by 10% From Baseline on FACT-P Sub-Scales | The time to definitive deterioration (10% decrease in score from baseline) was assessed for the individual sub-scales (Physical Well-Being; Social/Family Well-Being; Emotional Well-Being; Functional Well-Being; Prostate-Specific Concerns). Analysis was performed by Kaplan-Meier method. | Analysis was performed on FACT-P population. | Posted | Median | 95% Confidence Interval | months | From baseline until DP, start of another anti-cancer therapy, death or study cut-off date (maximum duration: 48 months) |
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| Secondary | Time to Definitive Deterioration of ECOG PS Score From Baseline | The ECOG PS was used to evaluate participant's DP and the effect of the disease on the participant's activities of daily living. It ranges on the scale from 0-5 (0= normal activity; 1= symptoms but ambulatory; 2= in bed for < 50 % of the time; 3= in bed for > 50% of the time; 4= 100% bedridden; 5= dead). Time to definitive deterioration in ECOG PS score from baseline was defined as a change from 0, 1 to ≥2, or from 2 to ≥3. Analysis was performed by Kaplan-Meier method. | Analysis was performed on ITT population. | Posted | Median | 95% Confidence Interval | months | From baseline until death or study cut-off date (maximum duration: 48 months) |
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| Secondary | Time to Definitive Weight Loss by 5% and 10% From Baseline | Time to definitive weight loss was defined as the time to first occurrence of ≥5% or ≥10% decrease in body weight from baseline. Analysis was performed by Kaplan-Meier method. | Analysis was performed on ITT population. | Posted | Median | 95% Confidence Interval | months | From baseline until death or study cut-off date (maximum duration: 48 months) |
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| Secondary | Time to First Definitive Consumption of Narcotic Medication | Concomitant medications used were recorded for all participants, and time of first definitive consumption of narcotic medication (if it occurred) was determined. This measure summarizes the time from baseline to first definitive consumption of narcotic medication. Analysis was performed by Kaplan-Meier method. | Analysis was performed on ITT population. | Posted | Median | 95% Confidence Interval | months | From baseline until DP, start of another anti-cancer therapy, death or study cut-off date (maximum duration: 48 months) |
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| Secondary | Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) | Any untoward medical occurrence in a participant who received investigational medicinal product (IMP) was considered an adverse event (AE) without regard to possibility of causal relationship with this treatment. TEAEs: AEs that developed or worsened or became serious during on-treatment period. On-treatment period: The time from the first dose of treatment to 30 days after the last dose of treatment (either Cabazitaxel or Prednisone). A serious adverse event: Any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs. National Cancer Institute Common Terminology Criteria (NCI-CTCAE) version 4.03 (Grade 3 [severe] and Grade 4 [life-threatening]) was used in this study to grade clinical AEs. | Safety population included all randomized participants who received at least one dose of the study drug during study treatment period. | Posted | Number | percentage of participants | From first administration of study treatment until 30 days after the last administration of study treatment (Maximum duration: 48 months) |
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| Secondary | Plasma Clearance (CL) for Cabazitaxel | Blood samples for pharmacokinetic (PK) analysis were obtained from a subset of the study participants (approximately 150 participants/group, by protocol) according to a sparse sampling strategy. | Analysis was performed on PK population that included participants who had evaluable PK data. Number of participants analyzed= participants with PK assessment at specified time-points. | Posted | Mean | Standard Deviation | Litre/hour | Day 1 of Cycle 1: 5 minutes before the end of infusion (EOI), 15 minutes, 1 to 4 hour, 6 to 24 hours, 48 to 168 hour after EOI |
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| Secondary | Plasma Steady State Volume of Distribution (Vss) for Cabazitaxel | Blood samples for PK analysis were obtained from a subset of the study participants (approximately 150 participants/group, by protocol) according to a sparse sampling strategy. | Analysis was performed on PK population. Number of participants analyzed= participants with PK assessment at specified time-points. | Posted | Mean | Standard Deviation | litre | Day 1 of Cycle 1: 5 minutes before the EOI, 15 minutes, 1 to 4 hour, 6 to 24 hours, 48 to 168 hour after EOI |
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All AEs were collected from signature of the informed consent form up to the final visit (48 months) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug until 30 days after the last administration of study drug). Analysis was performed on safety population.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cabazitaxel 20 mg/m^2 | Cabazitaxel 20 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles. | 177 | 580 | 450 | 580 | ||
| EG001 | Cabazitaxel 25 mg/m^2 | Cabazitaxel 25 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles. | 257 | 595 | 507 | 595 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal infection | Infections and infestations | MedDra 18.0 | Systematic Assessment |
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| Amoebic dysentery | Infections and infestations | MedDra 18.0 | Systematic Assessment |
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| Arthritis bacterial | Infections and infestations | MedDra 18.0 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDra 18.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDra 18.0 | Systematic Assessment |
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| Cholecystitis infective | Infections and infestations | MedDra 18.0 | Systematic Assessment |
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| Clostridial infection | Infections and infestations | MedDra 18.0 | Systematic Assessment |
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| Clostridium bacteraemia | Infections and infestations | MedDra 18.0 | Systematic Assessment |
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| Device related infection | Infections and infestations | MedDra 18.0 | Systematic Assessment |
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| Erysipelas | Infections and infestations | MedDra 18.0 | Systematic Assessment |
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| Escherichia sepsis | Infections and infestations | MedDra 18.0 | Systematic Assessment |
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| Febrile infection | Infections and infestations | MedDra 18.0 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDra 18.0 | Systematic Assessment |
| |
| Listeriosis | Infections and infestations | MedDra 18.0 | Systematic Assessment |
| |
| Liver abscess | Infections and infestations | MedDra 18.0 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDra 18.0 | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDra 18.0 | Systematic Assessment |
| |
| Lymphangitis | Infections and infestations | MedDra 18.0 | Systematic Assessment |
| |
| Mastoiditis | Infections and infestations | MedDra 18.0 | Systematic Assessment |
| |
| Neutropenic infection | Infections and infestations | MedDra 18.0 | Systematic Assessment |
| |
| Neutropenic sepsis | Infections and infestations | MedDra 18.0 | Systematic Assessment |
| |
| Pelvic abscess | Infections and infestations | MedDra 18.0 | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDra 18.0 | Systematic Assessment |
| |
| Phlebitis infective | Infections and infestations | MedDra 18.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDra 18.0 | Systematic Assessment |
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| Pyelonephritis | Infections and infestations | MedDra 18.0 | Systematic Assessment |
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| Pyelonephritis acute | Infections and infestations | MedDra 18.0 | Systematic Assessment |
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| Respiratory tract infection | Infections and infestations | MedDra 18.0 | Systematic Assessment |
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| Scrotal infection | Infections and infestations | MedDra 18.0 | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDra 18.0 | Systematic Assessment |
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| Septic shock | Infections and infestations | MedDra 18.0 | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDra 18.0 | Systematic Assessment |
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| Staphylococcal bacteraemia | Infections and infestations | MedDra 18.0 | Systematic Assessment |
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| Staphylococcal infection | Infections and infestations | MedDra 18.0 | Systematic Assessment |
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| Tracheobronchitis | Infections and infestations | MedDra 18.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDra 18.0 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDra 18.0 | Systematic Assessment |
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| Urinary tract infection bacterial | Infections and infestations | MedDra 18.0 | Systematic Assessment |
| |
| Urinary tract infection staphylococcal | Infections and infestations | MedDra 18.0 | Systematic Assessment |
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| Urosepsis | Infections and infestations | MedDra 18.0 | Systematic Assessment |
| |
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 18.0 | Systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 18.0 | Systematic Assessment |
| |
| Gastrointestinal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 18.0 | Systematic Assessment |
| |
| Glioblastoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 18.0 | Systematic Assessment |
| |
| Laryngeal squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 18.0 | Systematic Assessment |
| |
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 18.0 | Systematic Assessment |
| |
| Metastases to spine | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 18.0 | Systematic Assessment |
| |
| Metastatic pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 18.0 | Systematic Assessment |
| |
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 18.0 | Systematic Assessment |
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| Tumour associated fever | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 18.0 | Systematic Assessment |
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| Anaemia | Blood and lymphatic system disorders | MedDra 18.0 | Systematic Assessment |
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| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDra 18.0 | Systematic Assessment |
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| Febrile bone marrow aplasia | Blood and lymphatic system disorders | MedDra 18.0 | Systematic Assessment |
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| Febrile neutropenia | Blood and lymphatic system disorders | MedDra 18.0 | Systematic Assessment |
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| Haemolytic uraemic syndrome | Blood and lymphatic system disorders | MedDra 18.0 | Systematic Assessment |
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| Haemorrhagic anaemia | Blood and lymphatic system disorders | MedDra 18.0 | Systematic Assessment |
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| Leukopenia | Blood and lymphatic system disorders | MedDra 18.0 | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDra 18.0 | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDra 18.0 | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDra 18.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDra 18.0 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDra 18.0 | Systematic Assessment |
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| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDra 18.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDra 18.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDra 18.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDra 18.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDra 18.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDra 18.0 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDra 18.0 | Systematic Assessment |
| |
| Panic attack | Psychiatric disorders | MedDra 18.0 | Systematic Assessment |
| |
| Ataxia | Nervous system disorders | MedDra 18.0 | Systematic Assessment |
| |
| Cerebral haematoma | Nervous system disorders | MedDra 18.0 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDra 18.0 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDra 18.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDra 18.0 | Systematic Assessment |
| |
| Hydrocephalus | Nervous system disorders | MedDra 18.0 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDra 18.0 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDra 18.0 | Systematic Assessment |
| |
| Lumbosacral plexopathy | Nervous system disorders | MedDra 18.0 | Systematic Assessment |
| |
| Monoparesis | Nervous system disorders | MedDra 18.0 | Systematic Assessment |
| |
| Nerve compression | Nervous system disorders | MedDra 18.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDra 18.0 | Systematic Assessment |
| |
| Paraparesis | Nervous system disorders | MedDra 18.0 | Systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | MedDra 18.0 | Systematic Assessment |
| |
| Peripheral sensorimotor neuropathy | Nervous system disorders | MedDra 18.0 | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDra 18.0 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDra 18.0 | Systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | MedDra 18.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDra 18.0 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDra 18.0 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDra 18.0 | Systematic Assessment |
| |
| Visual acuity reduced | Eye disorders | MedDra 18.0 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDra 18.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDra 18.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDra 18.0 | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDra 18.0 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDra 18.0 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDra 18.0 | Systematic Assessment |
| |
| Cardiorenal syndrome | Cardiac disorders | MedDra 18.0 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDra 18.0 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDra 18.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDra 18.0 | Systematic Assessment |
| |
| Embolism venous | Vascular disorders | MedDra 18.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDra 18.0 | Systematic Assessment |
| |
| Hypovolaemic shock | Vascular disorders | MedDra 18.0 | Systematic Assessment |
| |
| Venous thrombosis limb | Vascular disorders | MedDra 18.0 | Systematic Assessment |
| |
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDra 18.0 | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDra 18.0 | Systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDra 18.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDra 18.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDra 18.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDra 18.0 | Systematic Assessment |
| |
| Lung consolidation | Respiratory, thoracic and mediastinal disorders | MedDra 18.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDra 18.0 | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDra 18.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDra 18.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDra 18.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDra 18.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDra 18.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDra 18.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDra 18.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDra 18.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDra 18.0 | Systematic Assessment |
| |
| Diverticular perforation | Gastrointestinal disorders | MedDra 18.0 | Systematic Assessment |
| |
| Diverticulum intestinal haemorrhagic | Gastrointestinal disorders | MedDra 18.0 | Systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | MedDra 18.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDra 18.0 | Systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MedDra 18.0 | Systematic Assessment |
| |
| Enterovesical fistula | Gastrointestinal disorders | MedDra 18.0 | Systematic Assessment |
| |
| Erosive oesophagitis | Gastrointestinal disorders | MedDra 18.0 | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDra 18.0 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDra 18.0 | Systematic Assessment |
| |
| Gastrointestinal ischaemia | Gastrointestinal disorders | MedDra 18.0 | Systematic Assessment |
| |
| Ileus paralytic | Gastrointestinal disorders | MedDra 18.0 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDra 18.0 | Systematic Assessment |
| |
| Intestinal haemorrhage | Gastrointestinal disorders | MedDra 18.0 | Systematic Assessment |
| |
| Large intestine perforation | Gastrointestinal disorders | MedDra 18.0 | Systematic Assessment |
| |
| Mesenteric vein thrombosis | Gastrointestinal disorders | MedDra 18.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDra 18.0 | Systematic Assessment |
| |
| Neutropenic colitis | Gastrointestinal disorders | MedDra 18.0 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDra 18.0 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDra 18.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDra 18.0 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDra 18.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDra 18.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDra 18.0 | Systematic Assessment |
| |
| Gallbladder obstruction | Hepatobiliary disorders | MedDra 18.0 | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDra 18.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDra 18.0 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDra 18.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDra 18.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDra 18.0 | Systematic Assessment |
| |
| Bursitis | Musculoskeletal and connective tissue disorders | MedDra 18.0 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDra 18.0 | Systematic Assessment |
| |
| Muscle haemorrhage | Musculoskeletal and connective tissue disorders | MedDra 18.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDra 18.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDra 18.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDra 18.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDra 18.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDra 18.0 | Systematic Assessment |
| |
| Osteitis | Musculoskeletal and connective tissue disorders | MedDra 18.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDra 18.0 | Systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDra 18.0 | Systematic Assessment |
| |
| Spinal pain | Musculoskeletal and connective tissue disorders | MedDra 18.0 | Systematic Assessment |
| |
| Vertebral foraminal stenosis | Musculoskeletal and connective tissue disorders | MedDra 18.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDra 18.0 | Systematic Assessment |
| |
| Azotaemia | Renal and urinary disorders | MedDra 18.0 | Systematic Assessment |
| |
| Cystitis haemorrhagic | Renal and urinary disorders | MedDra 18.0 | Systematic Assessment |
| |
| Cystitis noninfective | Renal and urinary disorders | MedDra 18.0 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDra 18.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDra 18.0 | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDra 18.0 | Systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MedDra 18.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDra 18.0 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDra 18.0 | Systematic Assessment |
| |
| Ureteric obstruction | Renal and urinary disorders | MedDra 18.0 | Systematic Assessment |
| |
| Urinary bladder toxicity | Renal and urinary disorders | MedDra 18.0 | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDra 18.0 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDra 18.0 | Systematic Assessment |
| |
| Urinary tract inflammation | Renal and urinary disorders | MedDra 18.0 | Systematic Assessment |
| |
| Urinary tract obstruction | Renal and urinary disorders | MedDra 18.0 | Systematic Assessment |
| |
| Oedema genital | Reproductive system and breast disorders | MedDra 18.0 | Systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | MedDra 18.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDra 18.0 | Systematic Assessment |
| |
| Catheter site inflammation | General disorders | MedDra 18.0 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDra 18.0 | Systematic Assessment |
| |
| Death | General disorders | MedDra 18.0 | Systematic Assessment |
| |
| Device occlusion | General disorders | MedDra 18.0 | Systematic Assessment |
| |
| Disease progression | General disorders | MedDra 18.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDra 18.0 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDra 18.0 | Systematic Assessment |
| |
| Infusion site extravasation | General disorders | MedDra 18.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDra 18.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDra 18.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDra 18.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDra 18.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDra 18.0 | Systematic Assessment |
| |
| Sudden cardiac death | General disorders | MedDra 18.0 | Systematic Assessment |
| |
| Sudden death | General disorders | MedDra 18.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDra 18.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDra 18.0 | Systematic Assessment |
| |
| Transaminases increased | Investigations | MedDra 18.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDra 18.0 | Systematic Assessment |
| |
| Accidental overdose | Injury, poisoning and procedural complications | MedDra 18.0 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDra 18.0 | Systematic Assessment |
| |
| Chemical cystitis | Injury, poisoning and procedural complications | MedDra 18.0 | Systematic Assessment |
| |
| Cystitis radiation | Injury, poisoning and procedural complications | MedDra 18.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDra 18.0 | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDra 18.0 | Systematic Assessment |
| |
| Fractured sacrum | Injury, poisoning and procedural complications | MedDra 18.0 | Systematic Assessment |
| |
| Gastroenteritis radiation | Injury, poisoning and procedural complications | MedDra 18.0 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDra 18.0 | Systematic Assessment |
| |
| Post-traumatic pain | Injury, poisoning and procedural complications | MedDra 18.0 | Systematic Assessment |
| |
| Radiation proctitis | Injury, poisoning and procedural complications | MedDra 18.0 | Systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | MedDra 18.0 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDra 18.0 | Systematic Assessment |
| |
| Urinary anastomotic leak | Injury, poisoning and procedural complications | MedDra 18.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary tract infection | Infections and infestations | MedDra 18.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDra 18.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDra 18.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDra 18.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDra 18.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDra 18.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDra 18.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDra 18.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDra 18.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDra 18.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDra 18.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDra 18.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDra 18.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDra 18.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDra 18.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDra 18.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDra 18.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDra 18.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDra 18.0 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDra 18.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDra 18.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDra 18.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDra 18.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDra 18.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDra 18.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDra 18.0 | Systematic Assessment |
| |
| Wrong technique in drug usage process | Injury, poisoning and procedural complications | MedDra 18.0 | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Trial Transparency Team | Sanofi | Contact-US@sanofi.com |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C552428 | cabazitaxel |
| C532412 | XRP6258 |
| D011241 | Prednisone |
| D011239 | Prednisolone |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D011246 | Pregnadienetriols |
Not provided
Not provided
| Title | Measurements |
|---|---|
|
| ≥75 years |
|
| Male |
|
Non-inferiority margin of 1.214 |
| The hazard ratio for OS was estimated using the Cox proportional hazards regression model. The Cox proportional hazard model was adjusted by measurability of the disease at baseline, ECOG PS score at baseline, and region at the time of randomization. Cabazitaxel 25 mg/m^2 was considered to be superior to 20 mg/m^2 dose if the lower bound of 1-sided 95% confidence interval of hazard ratio was greater than 1. | Hazard Ratio (HR) | 1.024 | 1-Sided | 95 | 0.922 | Cabazitaxel 20 mg/m^2 vs Cabazitaxel 25 mg/m^2 | Superiority or Other |
| Cabazitaxel 25 mg/m^2 |
Cabazitaxel 25 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles. |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
Cabazitaxel 25 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles. |
|
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
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|
Cabazitaxel 25 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles. |
|
|
|
|
|
|
| Counts |
|---|
| Participants |
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| Units | Counts |
|---|---|
| Participants |
|
|
|
| Counts |
|---|
| Participants |
|
|
| OG001 | Cabazitaxel 25 mg/m^2 | Cabazitaxel 25 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles. |
|
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| Counts |
|---|
| Participants |
|
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| Participants |
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|