Prostate Cancer MetastaticPhase 4NCT02074137
Evaluation of Safety of Cabazitaxel (Jevtana) in Patients With Metastatic Hormone Refractory Prostate Cancer
A Phase 4 study testing CABAZITAXEL XRP6258, Prednisone and Prednisolone in people with Prostate Cancer Metastatic, run by Sanofi at 3 sites in India.
Trial summary
Primary Objective: To evaluate the safety of cabazitaxel (Jevtana) in patients with metastatic hormone refractory prostate cancer Secondary Objectives: 1. To describe the use of cabazitaxel (Jevtana) in combination with oral prednisolone for the treatment of patients with metastatic Hormone Refractory Prostate Cancer… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer Metastatic
- What is being tested?
- CABAZITAXEL XRP6258, Prednisone and Prednisolone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 3 sitesIndia
- Study dates
- Jul 2014to Mar 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
- Metastatic hormone refractory prostate cancer (mHRPC) previously treated with a docetaxel-containing regimen
- Disease Progression during or after docetaxel-containing regimen for mHRPC
- Surgical or medical castration
- Patient is ≥ 18 years and ≤ 75 years of age
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
- Adequate bone marrow, liver, and renal function: Neutrophils> 1500 /mm3; Hemoglobin > 10 g/dL; Platelets > 100 x109/L; Bilirubin < Upper Normal Limit (ULN); Serum Glutamate Oxaloacetate Transaminase (Aspartate Aminotransferase)/SGOT (AST) < 1.5xULN; Serum Glutamate Pyruvate Transaminase (Alanine Aminotransferase)/SGPT (ALT) < 1.5xULN; Creatinine < 1.5xULN. In case of creatinine > 1.0 x ULN and < or = 1.5 x ULN, calculated creatinine clearance according to CKD-EPI formula should be > or = 60 ml/min.
- Written informed consent must be obtained prior to any study related procedures
Who cannot join
- Prior radiotherapy to ≥ 40% of bone marrow
- Previous treatment with cabazitaxel (Jevtana®)
- Prior surgery, radiation, chemotherapy, or other anti-cancer therapy within 4 weeks prior to enrollment
- Active grade ≥2 peripheral neuropathy
- Active grade ≥2 stomatitis
- Active infection requiring systemic antibiotic or anti-fungal medication
Show all 15Show fewer
- Active cancer (other than mHRPC) including prior malignancy from which the patient has been disease-free for ≤5 years
- Known brain or leptomeningeal involvement
- History of severe hypersensitivity reaction (≥grade 3) to docetaxel
- History of severe hypersensitivity reaction (≥grade 3) to polysorbate 80 containing drugs
- History of severe hypersensitivity reaction (≥grade 3) or intolerance to prednisone or prednisolone
- Uncontrolled severe illness or medical condition (including uncontrolled diabetes mellitus)
- Concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome P450 3A4/5 (a 2 weeks wash-out period is necessary for patients who are already on these treatments). Participation in any other clinical trial with any investigational drug
- Patient with reproductive potential not implementing accepted and effective method of contraception
- 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
3 sites in 1 country.
India3 sites
Investigational Site Number 356005
Kollkata, 700053
Investigational Site Number 356003
New Delhi, 110085
Investigational Site Number 356002
Trivandrum, 695011
About this study
Official title: Multicentre, Single Arm, Open Label, Non Controlled Phase IV Clinical Trial to Evaluate Safety of Cabazitaxel (Jevtana) in Combination With Oral Prednisone (or Prednisolone) for the Treatment of Patients With Metastatic Hormone Refractory Prostate Cancer Previously Treated With a Docetaxel-containing Regimen
Primary Objective:
To evaluate the safety of cabazitaxel (Jevtana) in patients with metastatic hormone refractory prostate cancer
Secondary Objectives:
- To describe the use of cabazitaxel (Jevtana) in combination with oral prednisolone for the treatment of patients with metastatic Hormone Refractory Prostate Cancer
- To describe patient profile in terms of demography, disease characteristics and prior treatment history
- To describe efficacy outcomes: radiological response (if available) using Recist criteria V 1.1 and Prostate Specific Antigen (PSA) response
Read the detailed description
The study consists of:
- a screening phase (maximum length of 7-day).
- a treatment phase with 21-day study treatment cycles. Patients continue to receive treatment until disease progression , death, unacceptable toxicity, investigator's decision or withdrawal of consent.
- a 30-day follow-up visit after the last dose of study medication.
- Conditions
- Prostate Cancer Metastatic
- Being tested
- CABAZITAXEL XRP6258, Prednisone, Prednisolone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CABAZITAXEL XRP6258Drug
Pharmaceutical form:Solution Route of administration: Intravenous
PrednisoneDrug
Pharmaceutical form:Tablet Route of administration: Oral
PrednisoloneDrug
Pharmaceutical form:Tablet Route of administration: Oral
| Study group | Role | What they receive |
|---|---|---|
| Cabazitaxel | Experimental | Cabazitaxel 25 mg/m² intravenously every 3 weeks, in combination with oral prednisone or prednisolone 10 mg daily Receives: Drug: CABAZITAXEL XRP6258; Drug: Prednisone; Drug: Prednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with Related Serious Adverse Events
Measured: up to13 months
Secondary outcomes (3)
Evaluation of use of cabazitaxel in terms of treatment duration, number of cycles, dose modifications
Measured: up to 13 months
Radiological overall response (if radiological tumor assessment done) using Recist criteria
Measured: up to 13 months
Number of patients with at least 50% decrease in PSA
Measured: up to 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2014 (estimated)
- Study startJul 2014
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer MetastaticStudies 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
- 10 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
- NCT02074137
- Sponsor's protocol ID
- CABAZL06499
- Other IDs
- U1111-1131-3161
- Status last verified
- Jun 2016
- First submitted
- 26 Feb 2014
- Last updated
- 2 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre, Single Arm, Open Label, Non Controlled Phase IV Clinical Trial to Evaluate Safety of Cabazitaxel (Jevtana) in Combination With Oral Prednisone (or Prednisolone) for the Treatment of Patients With Metastatic Hormone Refractory Prostate Cancer Previously Treated With a Docetaxel-containing Regimen
- ClinicalTrials.gov ID
- NCT02074137
- Acronym / sponsor ID
- CABAZL06499
- Conditions
- Prostate Cancer Metastatic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 28 Feb 2014 (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 evaluate the safety of cabazitaxel (Jevtana) in patients with metastatic hormone refractory prostate cancer
Secondary Objectives:
- To describe the use of cabazitaxel (Jevtana) in combination with oral prednisolone for the treatment of patients with metastatic Hormone Refractory Prostate Cancer
- To describe patient profile in terms of demography, disease characteristics and prior treatment history
- To describe efficacy outcomes: radiological response (if available) using Recist criteria V 1.1 and Prostate Specific Antigen (PSA) response
Detailed description
The study consists of:
- a screening phase (maximum length of 7-day).
- a treatment phase with 21-day study treatment cycles. Patients continue to receive treatment until disease progression , death, unacceptable toxicity, investigator's decision or withdrawal of consent.
- a 30-day follow-up visit after the last dose of study medication.
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: PrednisoloneCabazitaxel 25 mg/m² intravenously every 3 weeks, in combination with oral prednisone or prednisolone 10 mg daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Metastatic hormone refractory prostate cancer (mHRPC) previously treated with a docetaxel-containing regimen
- Disease Progression during or after docetaxel-containing regimen for mHRPC
- Surgical or medical castration
- Patient is ≥ 18 years and ≤ 75 years of age
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
Key exclusion criteria (15 listed)
- Prior radiotherapy to ≥ 40% of bone marrow
- Previous treatment with cabazitaxel (Jevtana®)
- Prior surgery, radiation, chemotherapy, or other anti-cancer therapy within 4 weeks prior to enrollment
- Active grade ≥2 peripheral neuropathy
- Active grade ≥2 stomatitis
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 XRP6258Pharmaceutical form:Solution Route of administration: Intravenous | Drug | Cabazitaxel |
| PrednisonePharmaceutical form:Tablet Route of administration: Oral | Drug | Cabazitaxel |
| PrednisolonePharmaceutical form:Tablet Route of administration: Oral | Drug | Cabazitaxel |
Primary outcome
Number of patients with Related Serious Adverse Events
Time frame: up to13 months
3 secondary outcomes
Evaluation of use of cabazitaxel in terms of treatment duration, number of cycles, dose modifications
Time frame: up to 13 months
Radiological overall response (if radiological tumor assessment done) using Recist criteria
Time frame: up to 13 months
Number of patients with at least 50% decrease in PSA
Time frame: up to 13 months
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 2 Jun 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
3 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 Prednisolone in people with Prostate Cancer Metastatic, run by Sanofi at 3 sites in India.
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 7 inclusion and 15 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 2 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in India. 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?
Number of patients with Related Serious Adverse Events (time frame: up to13 months). 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 2 Jun 2016.