Prostate CancerPhase 4PROSPECTANCT01649635
Study of Cabazitaxel Combined With Prednisone and Prophylaxis of Neutropenia Complications in the Treatment of Patients With Metastatic Castration-resistant Prostate Cancer
A Phase 4 study testing CABAZITAXEL (XRP6258), Prednisone and Ciprofloxacin in people with Prostate Cancer, run by Sanofi at 6 sites in Brazil.
Trial summary
Primary Objective: To assess effectiveness of prophylactic treatment of hematological complications (grade ≥ 3 neutropenia) resulting from cabazitaxel treatment for 21 days after treatment initiation. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- CABAZITAXEL (XRP6258), Prednisone and Ciprofloxacin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 6 sitesBrazil
- Study dates
- Jul 2012to Jun 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically proven Castration-Resistant Prostate Cancer (stage IV only);
- Prior failure of treatment with docetaxel; o Documentation of metastasis by imaging.
- Performance status 0 or 1;
Who cannot join
- Previous treatment with chemotherapy, except for docetaxel;
- Previous use of abiraterone;
- Inability to maintain treatment with androgen deprivation if no previous history of orchiectomy;
- Presence of any other active malignancy or history of any tumor diagnosed in the last 5 years, except basal cell or squamous cell carcinoma of the skin or in situ carcinoma of the skin, bladder or anal canal (these tumors do not prevent participation if they have been treated, even in the last 5 years);
- Hypersensitivity or known allergy to any of the treatments under study, including history of severe hypersensitivity reaction (≥grade 3) to docetaxel and/or to polysorbate 80 containing drugs
- History of congestive heart failure or myocardial infarction within the last 6 months, or uncontrolled cardiac arrhythmias, angina pectoris or uncontrolled hypertension;
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- Uncontrolled severe illness or medical condition (including uncontrolled diabetes mellitus)
- Presence of severe comorbidity, which in the opinion of the investigator, puts the patient at risk or impairs compliance to the protocol;
- Known seropositivity for HIV;
- Presence of significant psychiatric or neurological disease, in the investigator's opinion;
- Presence of uncontrolled hypercalcemia;
- Refusal to use appropriate contraception during the study period;
- Participation in any clinical trial in the last 12 months, unless there is benefit to the patient to be justified by the principal investigator
- Concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome P450 3A4/5
- Inadequate organ and bone marrow function
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Brazil6 sites
Investigational Site Number 007
Centro, 78020-400
Investigational Site Number 004
Curitiba, 81520-060
Investigational Site Number 006
Lajeado, 95900-000
Investigational Site Number 005
Porto Alegre, 90035-903
Investigational Site Number 001
Santo André, 09050-360
Investigational Site Number 002
São Paulo, 01321-001
About this study
Official title: A Phase IV, Multicenter, National, Non-comparative, Open-label Study of Cabazitaxel, Combined With Prednisone and Prophylaxis of Neutropenia Complications in the Second-line Treatment of Patients With Metastatic Castration-resistant Prostate Cancer and After Failure of Docetaxel-based Chemotherapy. Descriptive Assessment of the Circulating Tumor Cells in This Context.
Primary Objective:
- To assess effectiveness of prophylactic treatment of hematological complications (grade ≥ 3 neutropenia) resulting from cabazitaxel treatment for 21 days after treatment initiation.
Secondary Objectives:
- PSA response rate;
- Descriptive assessment of CTC (circulating Tumor Cells);
- Rates of grade ≥ 3 neutropenia and febrile neutropenia and grade ≥3 diarrhea over the treatment period;
- Description of the Health Quality of Life of the patients;
- Incidence of adverse events.
Read the detailed description
Screening: 15 days Treatment: until disease progression Post-treatment Follow-up: 12 months
- Conditions
- Prostate Cancer
- Being tested
- CABAZITAXEL (XRP6258), Prednisone, Ciprofloxacin, G-CSF (Granulocyte colony-stimulating factor)
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CABAZITAXEL (XRP6258)Drug
Pharmaceutical form: solution Route of administration: intravenous
PrednisoneDrug
Pharmaceutical form: tablet Route of administration: oral
CiprofloxacinDrug
Pharmaceutical form: tablet Route of administration: oral
G-CSF (Granulocyte colony-stimulating factor)Drug
Pharmaceutical form: solution Route of administration: subcutaneous
| Study group | Role | What they receive |
|---|---|---|
| Cabazitaxel | Experimental | 25 mg/m2, administered as a 1-hour intravenous infusion, on Day 1 of each cycle, every 21 days Prednisone: 10 mg daily throughout the treatment with cabazitaxel Ciprofloxacin: at a dose of 500 mg for 8 days twice daily (total dose 1.0 g) Granulocyte-Colony Stimulating Factors: maximum dose of 600ug for 7 days or until Absolute Neutrophils Count reaches level ≥ 10.000/mm3 Receives: Drug: CABAZITAXEL (XRP6258); Drug: Prednisone; Drug: Ciprofloxacin; Drug: G-CSF (Granulocyte colony-stimulating factor) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with some episode of neutropenia classified as grade ≥ 3
Measured: 21 days
Secondary outcomes (7)
Proportion of patients with episode of neutropenia grade ≥3
Measured: up to 24 months (every 21 days)
Rate of febrile neutropenia
Measured: up to 24 months (every 21 days)
Rate of diarrhea grade ≥3
Measured: up to 24 months (every 21 days)
PSA response rate
Measured: up to 24 months (every 21 days)
Circulating Tumor Cells Count (CTC) rate
Measured: Day 42, Day 84, Day 126 and End of Treatment
Changes from baseline in score derived from the Functional assessment of cancer therapy-prostate (FACT-P) and the Trial Outcome Index (TOI)
Measured: up to 24 months (every 21 days)
Number of patients with adverse events
Measured: up to 24 months (every 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionJan 2014
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01649635
- Sponsor's protocol ID
- CABAZ_L_06003
- Other IDs
- U1111-1123-9025
- Acronym
- PROSPECTA
- Status last verified
- Jul 2016
- First submitted
- 20 Jul 2012
- Last updated
- 6 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV, Multicenter, National, Non-comparative, Open-label Study of Cabazitaxel, Combined With Prednisone and Prophylaxis of Neutropenia Complications in the Second-line Treatment of Patients With Metastatic Castration-resistant Prostate Cancer and After Failure of Docetaxel-based Chemotherapy. Descriptive Assessment of the Circulating Tumor Cells in This Context.
- ClinicalTrials.gov ID
- NCT01649635
- Acronym / sponsor ID
- PROSPECTA / CABAZ_L_06003
- Conditions
- Prostate Cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 25 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Objective:
- To assess effectiveness of prophylactic treatment of hematological complications (grade ≥ 3 neutropenia) resulting from cabazitaxel treatment for 21 days after treatment initiation.
Secondary Objectives:
- PSA response rate;
- Descriptive assessment of CTC (circulating Tumor Cells);
- Rates of grade ≥ 3 neutropenia and febrile neutropenia and grade ≥3 diarrhea over the treatment period;
- Description of the Health Quality of Life of the patients;
- Incidence of adverse events.
Detailed description
Screening: 15 days Treatment: until disease progression Post-treatment Follow-up: 12 months
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cabazitaxel | Experimental | Drug: CABAZITAXEL (XRP6258), Drug: Prednisone, Drug: Ciprofloxacin, Drug: G-CSF (Granulocyte colony-stimulating factor)25 mg/m2, administered as a 1-hour intravenous infusion, on Day 1 of each cycle, every 21 days Prednisone: 10 mg daily throughout the treatment with cabazitaxel Ciprofloxacin: at a dose of 500 mg for 8 days twice daily (total dose 1.0 g) Granulocyte-Colony Stimulating Factors: maximum dose of 600ug for 7 days or until Absolute Neutrophils Count reaches level ≥ 10.000/mm3 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Histologically proven Castration-Resistant Prostate Cancer (stage IV only);
- Prior failure of treatment with docetaxel; o Documentation of metastasis by imaging.
- Performance status 0 or 1;
Key exclusion criteria (16 listed)
- Previous treatment with chemotherapy, except for docetaxel;
- Previous use of abiraterone;
- Inability to maintain treatment with androgen deprivation if no previous history of orchiectomy;
- Presence of any other active malignancy or history of any tumor diagnosed in the last 5 years, except basal cell or squamous cell carcinoma of the skin or in situ carcinoma of the skin, bladder or anal canal (these tumors do not prevent participation if they have been treated, even in the last 5 years);
- Hypersensitivity or known allergy to any of the treatments under study, including history of severe hypersensitivity reaction (≥grade 3) to docetaxel and/or to polysorbate 80 containing drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CABAZITAXEL (XRP6258)Pharmaceutical form: solution Route of administration: intravenous | Drug | Cabazitaxel |
| PrednisonePharmaceutical form: tablet Route of administration: oral | Drug | Cabazitaxel |
| CiprofloxacinPharmaceutical form: tablet Route of administration: oral | Drug | Cabazitaxel |
| G-CSF (Granulocyte colony-stimulating factor)Pharmaceutical form: solution Route of administration: subcutaneous | Drug | Cabazitaxel |
Primary outcome
Proportion of patients with some episode of neutropenia classified as grade ≥ 3
Time frame: 21 days
7 secondary outcomes
Proportion of patients with episode of neutropenia grade ≥3
Time frame: up to 24 months (every 21 days)
Rate of febrile neutropenia
Time frame: up to 24 months (every 21 days)
Rate of diarrhea grade ≥3
Time frame: up to 24 months (every 21 days)
PSA response rate
Time frame: up to 24 months (every 21 days)
Circulating Tumor Cells Count (CTC) rate
Time frame: Day 42, Day 84, Day 126 and End of Treatment
Changes from baseline in score derived from the Functional assessment of cancer therapy-prostate (FACT-P) and the Trial Outcome Index (TOI)
Time frame: up to 24 months (every 21 days)
Number of patients with adverse events
Time frame: up to 24 months (every 21 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Sciences & Operations study director
Sanofi
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing CABAZITAXEL (XRP6258), Prednisone and Ciprofloxacin in people with Prostate Cancer, run by Sanofi at 6 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with some episode of neutropenia classified as grade ≥ 3 (time frame: 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2016.