Prostatic NeoplasmsPhase 2SWITCHNCT01576029
Continued Treatment With Docetaxel Versus Switch to Cabazitaxel After Minor Prostate Specific Antigen Response to Docetaxel in Patients With Castration-Resistant Metastatic Prostate Cancer
A Phase 2 study testing CABAZITAXEL (XRP6258) and DOCETAXEL (XRP6976) in people with Prostatic Neoplasms, run by Sanofi at 8 sites in Brazil.
Trial summary
Primary Objective: To compare the continuation of treatment with docetaxel versus switching to cabazitaxel regarding the time to PSA (Prostatic Specific Antigen) progression (TTP-PSA), in patients with Castration-Resistant Prostate Cancer (CRPC) that, after four cycles of docetaxel, have minor PSA response (defined as… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostatic Neoplasms
- What is being tested?
- CABAZITAXEL (XRP6258) and DOCETAXEL (XRP6976)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 8 sitesBrazil
- Study dates
- Aug 2012to Dec 2013
- Phase
- Phase 2
- 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
- Documentation of histological prostate cancer;
- Patients with metastatic CRPC (Castration-Resistant Metastatic Prostate Cancer) who progressed with hormone deprivation, including the withdrawal of antiandrogen-class drugs for at least 4 weeks, and 6 weeks for bicalutamide or if documented that PSA did not decrease during 3 months of this therapy;
- Documentation of metastasis by imaging (computerized tomography [CT], magnetic resonance imaging [MRI] or bone scan), in patients with PSA < 20 ng/mL at the time of inclusion
- Provide minor PSA response (characterized by a reduction between 1% and 49%) or increase up to 24% in PSA levels, in relation to the value measured before starting docetaxel therapy, measured at least 7 days after the fourth cycle of docetaxel;
- Patient has received 4 cycles of docetaxel at a dose of 75 mg/m2 ;
- ECOG performance status of 0 or 1;
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- Marrow, liver and renal function within acceptable values;
- PSA ≥ 2 ng/mL;
- Testosterone level ≤ 50 ng/dL (for patients with no prior history of orchiectomy).
Who cannot join
- Prior use of chemotherapy, except for docetaxel for four cycles;
- Documented disease progression during treatment with docetaxel (first 4 cycles);
- Patients with metastases resulting in neurological damage;
- Inability to continue receiving gonadotropin-releasing hormone agonists in patients with no prior history of orchiectomy;
- Use of recombinant methionyl human granulocyte-colony stimulating factor non-glycosylated (G-CSF) in the 24 hours preceding baseline;
- Any other current neoplasia or over the past 5 years, except for basal cell skin carcinoma or squamous skin cell carcinoma;
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- Known seropositivity for HIV (Human immunodeficiency Virus );
- Concomitant diseases, such as significant neurological or psychiatric disease; uncontrolled hypercalcemia or any other serious comorbidity;
- Hypersensitivity or allergy to any of the study treatments.
- 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
8 sites in 1 country.
8 sites in 1 country
Brazil8 sites
Investigational Site Number 004
Barretos, 14780-480
Investigational Site Number 008
Brasília, 70390-150
Investigational Site Number 009
Londrina, 86015-520
Investigational Site Number 003
Mogi das Cruzes, 0830-500
Investigational Site Number 005
Porto Alegre, 90840-440
Investigational Site Number 006
Rio de Janeiro, 20231-050
Investigational Site Number 001
Rio de Janeiro, 22260-020
Investigational Site Number 007
São Paulo, 01246-000
About this study
Official title: Phase II Randomized Study of Continuing Treatment With Docetaxel Versus Switching to Cabazitaxel After Minor Prostate Specific Antigen Response to Docetaxel in the First Line Treatment of Patients With Castration-Resistant Metastatic Prostate Cancer.
Primary Objective:
- To compare the continuation of treatment with docetaxel versus switching to cabazitaxel regarding the time to PSA (Prostatic Specific Antigen) progression (TTP-PSA), in patients with Castration-Resistant Prostate Cancer (CRPC) that, after four cycles of docetaxel, have minor PSA response (defined as a reduction between 1% and 49%) or increase of up to 24% in PSA levels.
Secondary Objectives:
- PSA response rate
- Overall survival (OS)
- Incidence of Adverse Events
Read the detailed description
Screening: 21days (+7 days) Treatment: until PSA progression Post-treatment Follow-up: 2 years
- Conditions
- Prostatic Neoplasms
- Being tested
- CABAZITAXEL (XRP6258), DOCETAXEL (XRP6976)
- 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
DOCETAXEL (XRP6976)Drug
Pharmaceutical form: solution Route of administration: intravenous
| Study group | Role | What they receive |
|---|---|---|
| Docetaxel | Active comparator | 75 mg/m2, administered as a 1-hour intravenous infusion, every 3 weeks Receives: Drug: DOCETAXEL (XRP6976) |
| Cabazitaxel | Experimental | 25 mg/m2, administered as a 1-hour intravenous infusion, every 3 weeks Receives: Drug: CABAZITAXEL (XRP6258) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median time to PSA progression
Measured: up to 60 days
Secondary outcomes (3)
PSA response rate: Percentage of patients with a decrease of at least 50% in the PSA
Measured: up to 60 days
Overall Survival: Median time elapsed between the date of starting treatment until death by any cause
Measured: up to a maximum of 2 years
Number of patients with adverse events
Measured: up to a maximum of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2012 (estimated)
- Study startAug 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic NeoplasmsStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 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
- NCT01576029
- Sponsor's protocol ID
- CABAZ_L_05933
- Other IDs
- U1111-1119-8381
- Acronym
- SWITCH
- Status last verified
- Dec 2013
- First submitted
- 30 Mar 2012
- Last updated
- 24 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Randomized Study of Continuing Treatment With Docetaxel Versus Switching to Cabazitaxel After Minor Prostate Specific Antigen Response to Docetaxel in the First Line Treatment of Patients With Castration-Resistant Metastatic Prostate Cancer.
- ClinicalTrials.gov ID
- NCT01576029
- Acronym / sponsor ID
- SWITCH / CABAZ_L_05933
- Conditions
- Prostatic Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 12 Apr 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 compare the continuation of treatment with docetaxel versus switching to cabazitaxel regarding the time to PSA (Prostatic Specific Antigen) progression (TTP-PSA), in patients with Castration-Resistant Prostate Cancer (CRPC) that, after four cycles of docetaxel, have minor PSA response (defined as a reduction between 1% and 49%) or increase of up to 24% in PSA levels.
Secondary Objectives:
- PSA response rate
- Overall survival (OS)
- Incidence of Adverse Events
Detailed description
Screening: 21days (+7 days) Treatment: until PSA progression Post-treatment Follow-up: 2 years
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Docetaxel | Active comparator | Drug: DOCETAXEL (XRP6976)75 mg/m2, administered as a 1-hour intravenous infusion, every 3 weeks |
| Cabazitaxel | Experimental | Drug: CABAZITAXEL (XRP6258)25 mg/m2, administered as a 1-hour intravenous infusion, every 3 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Documentation of histological prostate cancer;
- Patients with metastatic CRPC (Castration-Resistant Metastatic Prostate Cancer) who progressed with hormone deprivation, including the withdrawal of antiandrogen-class drugs for at least 4 weeks, and 6 weeks for bicalutamide or if documented that PSA did not decrease during 3 months of this therapy;
- Documentation of metastasis by imaging (computerized tomography [CT], magnetic resonance imaging [MRI] or bone scan), in patients with PSA < 20 ng/mL at the time of inclusion
- Provide minor PSA response (characterized by a reduction between 1% and 49%) or increase up to 24% in PSA levels, in relation to the value measured before starting docetaxel therapy, measured at least 7 days after the fourth cycle of docetaxel;
- Patient has received 4 cycles of docetaxel at a dose of 75 mg/m2 ;
Key exclusion criteria (10 listed)
- Prior use of chemotherapy, except for docetaxel for four cycles;
- Documented disease progression during treatment with docetaxel (first 4 cycles);
- Patients with metastases resulting in neurological damage;
- Inability to continue receiving gonadotropin-releasing hormone agonists in patients with no prior history of orchiectomy;
- Use of recombinant methionyl human granulocyte-colony stimulating factor non-glycosylated (G-CSF) in the 24 hours preceding baseline;
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 |
| DOCETAXEL (XRP6976)Pharmaceutical form: solution Route of administration: intravenous | Drug | Docetaxel |
Primary outcome
Median time to PSA progression
Time frame: up to 60 days
3 secondary outcomes
PSA response rate: Percentage of patients with a decrease of at least 50% in the PSA
Time frame: up to 60 days
Overall Survival: Median time elapsed between the date of starting treatment until death by any cause
Time frame: up to a maximum of 2 years
Number of patients with adverse events
Time frame: up to a maximum of 2 years
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 24 Dec 2013.
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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
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CABAZITAXEL (XRP6258) and DOCETAXEL (XRP6976) in people with Prostatic Neoplasms, run by Sanofi at 8 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 9 inclusion and 10 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 24 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Median time to PSA progression (time frame: up to 60 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 24 Dec 2013.