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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01308567




Registration number
NCT01308567
Ethics application status
Date submitted
3/03/2011
Date registered
4/03/2011
Date last updated
5/06/2019

Titles & IDs
Public title
Cabazitaxel Versus Docetaxel Both With Prednisone in Patients With Metastatic Castration Resistant Prostate Cancer
Scientific title
Randomized, Open Label, Multi-Center Study Comparing Cabazitaxel at 25 mg/m^2 and at 20 mg/m^2 in Combination With Prednisone Every 3 Weeks to Docetaxel in Combination With Prednisone in Patients With Metastatic Castration Resistant Prostate Cancer Not Pretreated With Chemotherapy
Secondary ID [1] 0 0
2010-022064-12
Secondary ID [2] 0 0
EFC11784
Universal Trial Number (UTN)
Trial acronym
FIRSTANA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Cabazitaxel (XRP6258)
Treatment: Drugs - Docetaxel (XRP6976)
Treatment: Drugs - Prednisone

Experimental: Cabazitaxel 25 mg/m^2 - Cabazitaxel 25 mg/m\^2 intravenous (IV) infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until disease progression (DP), unacceptable toxicity or participant's refusal.

Experimental: Cabazitaxel 20 mg/m^2 - Cabazitaxel 20 mg/m\^2 IV infusion on Day 1 of each 21 -day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.

Active comparator: Docetaxel 75 mg/m^2 - Docetaxel (TXT) 75 mg/m\^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.


Treatment: Drugs: Cabazitaxel (XRP6258)
Pharmaceutical form: Solution for injection; Route of administration: Intravenous

Treatment: Drugs: Docetaxel (XRP6976)
Pharmaceutical form: Solution for injection'; Route of administration: Intravenous

Treatment: Drugs: Prednisone
Pharmaceutical form: Tablet; Route of administration: Oral
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Baseline up to death or study cut-off date, whichever was earlier (maximum duration: 51 months )
Secondary outcome [1] 0 0
Progression Free Survival (PFS)
Timepoint [1] 0 0
Baseline up to tumor progression, PSA progression, pain progression or death (maximum duration: 51 months)
Secondary outcome [2] 0 0
Time to Tumor Progression Free Survival
Timepoint [2] 0 0
Baseline up to tumor progression or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 51 months)
Secondary outcome [3] 0 0
Percentage of Participants With Overall Objective Tumor Response
Timepoint [3] 0 0
Baseline up to DP or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 51 months)
Secondary outcome [4] 0 0
Time to Prostate Serum Antigen Progression Free Survival (PSA-PFS)
Timepoint [4] 0 0
Baseline up to PSA progression or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 51 months)
Secondary outcome [5] 0 0
Percentage of Participants With PSA Response
Timepoint [5] 0 0
Baseline up to PSA progression or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 51 months)
Secondary outcome [6] 0 0
Time to Pain Progression Free Survival (Pain PFS)
Timepoint [6] 0 0
Baseline until disease progression, death or study cut-off date (maximum duration: 51 months)
Secondary outcome [7] 0 0
Percentage of Participants With Pain Response
Timepoint [7] 0 0
Baseline until pain progression, death or study cut-off date (maximum duration: 51 months)
Secondary outcome [8] 0 0
Skeletal Related Events (SRE) Free Survival
Timepoint [8] 0 0
Baseline until occurrence of first SRE or death (maximum duration: 51 months)
Secondary outcome [9] 0 0
Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Total Score as a Measure of Health Related Quality of Life (HRQoL)
Timepoint [9] 0 0
Baseline, Day 1 of each cycle 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 (each cycle 21-day); post-treatment follow up 1, 2, 3, 4, 5, 6 (each up to 12 weeks)
Secondary outcome [10] 0 0
Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P):Trial Outcome Index (TOI) as a Measure of HRQoL
Timepoint [10] 0 0
Baseline, Day 1 of each cycle 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 (each cycle 21-day); post-treatment follow up 1, 2, 3, 4, 5, 6 (each up to 12 weeks)

Eligibility
Key inclusion criteria
Inclusion criteria :

* I 01. Histologically- or cytologically-confirmed prostate adenocarcinoma.
* I 02. Metastatic disease.
* I 03. Progressive disease while receiving hormonal therapy or after surgical castration.
* I 04. Effective castration (serum testosterone levels =0.50 ng/mL) by orchiectomy and/or luteinizing hormone-releasing hormone (LHRH) agonists or antagonist with or without anti-androgens.
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

* E 01. Prior chemotherapy for prostate cancer,
* E 02. Less than 28 days elapsed from prior treatment with estramustine, radiotherapy or surgery to the time of randomization. Participants on biphosphonates prior to study entry.
* E 03. Prior isotope therapy, whole pelvic radiotherapy, or radiotherapy to >30% of bone marrow.
* E 04. 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 05. Less than 18 years (or country's legal age of majority if the legal age is >18 years).
* E 06. Eastern Cooperative Oncology Group (ECOG) performance status >2.
* E 07. History of brain metastases, uncontrolled spinal cord compression, or carcinomatous meningitis or new evidence of brain or leptomeningeal disease.
* E 08. Prior malignancy.
* E 09. Participation in another clinical trial and any concurrent treatment with any investigational drug within 30 days prior to randomization.
* E 10. 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 (NYHA) class III or IV congestive heart failure, stroke or transient ischemic attack.
* E 11. Any of the following within 3 months prior to randomization: treatment resistant peptic ulcer disease, erosive esophagitis or gastritis, infectious or inflammatory bowel disease, diverticulitis, pulmonary embolism, or other uncontrolled thromboembolic event.
* E 12. Acquired immunodeficiency syndrome (AIDS-related illnesses) or known HIV disease requiring antiretroviral treatment.
* E 13. Any severe acute or chronic medical condition which could impair the ability of the participant to participate to the study or interfere with interpretation of study results, or participants unable to comply with the study procedures.
* E 14. Absence of signed and dated Institutional Review Board (IRB)-approved participant informed consent form prior to enrollment into the study.
* E 15. Participants with reproductive potential who did not agree to use accepted and effective method of contraception during the study treatment period.
* E 16. History of hypersensitivity to docetaxel, or polysorbate 80.
* E 17. Inadequate organ and bone marrow function
* E 18. Contraindications to the use of corticosteroid treatment.
* E 19. Symptomatic peripheral neuropathy grade >2 (National Cancer Institute Common Terminology Criteria [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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
5/05/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2018
Sample size
Target
Accrual to date
Final
1168
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Investigational Site Number 036016 - Bankstown
Recruitment hospital [2] 0 0
Investigational Site Number 036008 - Camperdown
Recruitment hospital [3] 0 0
Investigational Site Number 036015 - Coffs Harbour
Recruitment hospital [4] 0 0
Investigational Site Number 036001 - Concord
Recruitment hospital [5] 0 0
Investigational Site Number 036017 - Fitzroy
Recruitment hospital [6] 0 0
Investigational Site Number 036003 - Herston
Recruitment hospital [7] 0 0
Investigational Site Number 036010 - Hornsby
Recruitment hospital [8] 0 0
Investigational Site Number 036012 - Kurralta Park
Recruitment hospital [9] 0 0
Investigational Site Number 036002 - Parkville
Recruitment hospital [10] 0 0
Investigational Site Number 036009 - South Brisbane
Recruitment hospital [11] 0 0
Investigational Site Number 036011 - Subiaco
Recruitment hospital [12] 0 0
Investigational Site Number 036013 - Wodonga
Recruitment postcode(s) [1] 0 0
2200 - Bankstown
Recruitment postcode(s) [2] 0 0
2050 - Camperdown
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2450 - Coffs Harbour
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2137 - Concord
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3065 - Fitzroy
Recruitment postcode(s) [6] 0 0
4029 - Herston
Recruitment postcode(s) [7] 0 0
2077 - Hornsby
Recruitment postcode(s) [8] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [9] 0 0
3050 - Parkville
Recruitment postcode(s) [10] 0 0
4101 - South Brisbane
Recruitment postcode(s) [11] 0 0
6008 - Subiaco
Recruitment postcode(s) [12] 0 0
3690 - Wodonga
Recruitment outside Australia
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Zaporizhzhya

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Sanofi
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Primary Objective:

* To demonstrate the superiority of cabazitaxel plus prednisone at 25 mg/m\^2 (Arm A) or 20 mg/m\^2 (Arm B) versus docetaxel plus prednisone (Arm C) in term of overall survival (OS) in participants with metastatic castration resistant prostate cancer (mCRPC) and not previously treated with chemotherapy.

Secondary Objectives:

* To evaluate safety in the 3 treatment arms.
* To compare efficacy of cabazitaxel at 20 mg/m\^2 and 25 mg/m\^2 to docetaxel for:

* Progression Free Survival (PFS) (RECIST 1.1)
* Tumor progression free survival (RECIST 1.1)
* Tumor response in participants with measurable disease (RECIST 1.1),
* PSA response
* PSA-Progression free survival (PSA-PFS).
* Pain response in participants with stable pain at baseline
* Pain progression free survival
* Time to occurrence of any skeletal related events (SRE)
* To compare Health-Related Quality of Life (HRQL).
* To assess the pharmacokinetics and pharmacogenomics of cabazitaxel.
Trial website
https://clinicaltrials.gov/study/NCT01308567
Trial related presentations / publications
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.
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.
Oudard S, Fizazi K, Sengelov L, Daugaard G, Saad F, Hansen S, Hjalm-Eriksson M, Jassem J, Thiery-Vuillemin A, Caffo O, Castellano D, Mainwaring PN, Bernard J, Shen L, Chadjaa M, Sartor O. Cabazitaxel Versus Docetaxel As First-Line Therapy for Patients With Metastatic Castration-Resistant Prostate Cancer: A Randomized Phase III Trial-FIRSTANA. J Clin Oncol. 2017 Oct 1;35(28):3189-3197. doi: 10.1200/JCO.2016.72.1068. Epub 2017 Jul 28.
de Liano AG, Reig O, Mellado B, Martin C, Rull EU, Maroto JP. Prognostic and predictive value of plasma testosterone levels in patients receiving first-line chemotherapy for metastatic castrate-resistant prostate cancer. Br J Cancer. 2014 Apr 29;110(9):2201-8. doi: 10.1038/bjc.2014.189. Epub 2014 Apr 10.
Winquist E, Rodrigues G. Open clinical uro-oncology trials in Canada. Can J Urol. 2012 Dec;19(6):6587-91. No abstract available.
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Sciences & Operations
Address 0 0
Sanofi
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01308567