Prostate CancerPhase 1NCT01324583
Dose Escalation Study With Cabazitaxel in Combination With Daily Prednisolone in Patients With Hormone Refractory Prostate Cancer
A Phase 1 study testing Cabazitaxel (XRP6258) and prednisolone in people with Prostate Cancer, run by Sanofi at 21 sites in Japan.
Trial summary
Primary Objective: To assess the tolerability at global doses Secondary Objectives: Safety Pharmacokinetics Efficacy Read more about this study
- Who is it for?
- Ages 20 to 73 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Cabazitaxel (XRP6258) 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
- 48 participants
- Where
- 21 sitesJapan
- Study dates
- Jan 2011to Nov 2014
- Phase
- Phase 1
- 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 20 to 73 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- I 01. Diagnosis of histologically or cytologically proven prostate adenocarcinoma, that is refractory to hormone therapy (received prior castration by orchiectomy and/or internal medicine, and documented progression of disease or relapse) who has previously been treated with docetaxel.
- I 02. Signed informed consent prior to beginning protocol specific procedures.
- I 03. Patients with PSA >20 ng/mL at screening.
Who cannot join
- E 01. Age <20 and >74
- E 02. ECOG performance status ≥2.
- E 03. Prior surgery ≤4 weeks of registration in the study.
- E 04. Active secondary cancer including prior malignancy from which the patient has been disease-free for ≤5 years (However, adequately treated superficial basal cell skin cancer before 4 weeks prior to registration can be eligible to the study)
- E 05. Inadequate organ function including:
- Neutrophils <2.0 x 109/L Platelets <100 x 109/L Hemoglobin <9.0 g/dL (transfusion prohibition within 14 days before registration) Creatinine >1.5 mg/dL. Total bilirubin >1.5 times the upper normal limits of the institutional norms ALT/AST >1.5 times the upper normal limits of the institutional norms
- E 06. Previous treatment with <225 mg/m2 cumulative dose of Taxotere® (or docetaxel).
- 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
21 sites in 1 country.
21 sites in 1 country
Japan21 sites
Investigational Site Number 392011
Bunkyō City
Investigational Site Number 392021
Fukuoka
Investigational Site Number 392014
Hamamatsu
Investigational Site Number 392001
Kashiwa-Shi
Investigational Site Number 392020
Kita-Gun
Investigational Site Number 392002
Kōtoku
Investigational Site Number 392016
Kyoto
Investigational Site Number 392017
Kyoto
Investigational Site Number 392008
Maebashi
Investigational Site Number 392012
Minatoku
Investigational Site Number 392015
Nagoya
Investigational Site Number 392019
Osaka Sayama-Shi
Investigational Site Number 392004
Sapporo
Investigational Site Number 392005
Sendai
Investigational Site Number 392010
Shinjuku-Ku
Investigational Site Number 392018
Suita-Shi
Investigational Site Number 392003
Sunto-Gun
Investigational Site Number 392009
tabashi City
Investigational Site Number 392007
Tsukuba
Investigational Site Number 392006
Yamagata
Investigational Site Number 392013
Yokohama
About this study
Official title: An Open Label, Dose Escalation, Safety and Pharmacokinetics Phase I Study With Cabazitaxel Administered as a 1-hour Intravenous Infusion Every 3 Weeks in Combination With Daily Prednisolone in Patients With Hormone Refractory Prostate Cancer
Primary Objective:
- To assess the tolerability at global doses
Secondary Objectives:
- Safety
- Pharmacokinetics
- Efficacy
Read the detailed description
The duration of screening within 28 days, treatment 3 weeks/cycle and follow-up 30 days after the last cabazitaxel administration.
- Conditions
- Prostate Cancer
- Being tested
- Cabazitaxel (XRP6258), prednisolone
- 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
prednisoloneDrug
Pharmaceutical form:tablet
Route of administration: oral
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Patients will receive cabazitaxel as the dose of corresponded level
1-hour intravenous infusion every 3 weeks plus prednisolone 10 mg orally given daily: Dose Level Cabazitaxel Dose Level -1: 15 mg/m², Level 1: 20 mg/m², Level 2: 25 mg/m² Receives: Drug: Cabazitaxel (XRP6258); Drug: prednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of maximum tolerated dose
Measured: up to 18 months
Secondary outcomes (3)
number of participants with treatment emergent adverse events
Measured: up to 18 months
Pharmakokinetic parameters of Cabazitaxel
Measured: up to 18 months
Prostate Specific Antigen (PSA) Response
Measured: up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2011 (estimated)
- Study startJan 2011
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 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
- NCT01324583
- Sponsor's protocol ID
- TED11576
- Other IDs
- U1111-1115-4154
- Status last verified
- Jan 2015
- First submitted
- 22 Mar 2011
- Last updated
- 7 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Nozawa M, Mukai H, Takahashi S, Uemura H, Kosaka T, Onozawa Y, Miyazaki J, Suzuki K, Okihara K, Arai Y, Kamba T, Kato M, Nakai Y, Furuse H, Kume H, Ide H, Kitamura H, Yokomizo A, Kimura T, Tomita Y, Ohno K, Kakehi Y. Japanese phase I study of cabazitaxel in metastatic castration-resistant prostate cancer. Int J Clin Oncol. 2015 Oct;20(5):1026-34. doi: 10.1007/s10147-015-0820-9. Epub 2015 Mar 26.
PubMed 25809824
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Dose Escalation, Safety and Pharmacokinetics Phase I Study With Cabazitaxel Administered as a 1-hour Intravenous Infusion Every 3 Weeks in Combination With Daily Prednisolone in Patients With Hormone Refractory Prostate Cancer
- ClinicalTrials.gov ID
- NCT01324583
- Acronym / sponsor ID
- TED11576
- Conditions
- Prostate Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 29 Mar 2011 (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 the tolerability at global doses
Secondary Objectives:
- Safety
- Pharmacokinetics
- Efficacy
Detailed description
The duration of screening within 28 days, treatment 3 weeks/cycle and follow-up 30 days after the last cabazitaxel administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Cabazitaxel (XRP6258), Drug: prednisolonePatients will receive cabazitaxel as the dose of corresponded level 1-hour intravenous infusion every 3 weeks plus prednisolone 10 mg orally given daily: Dose Level Cabazitaxel Dose Level -1: 15 mg/m², Level 1: 20 mg/m², Level 2: 25 mg/m² |
Who may qualify
- Ages
- 20 to 73 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- I 01. Diagnosis of histologically or cytologically proven prostate adenocarcinoma, that is refractory to hormone therapy (received prior castration by orchiectomy and/or internal medicine, and documented progression of disease or relapse) who has previously been treated with docetaxel.
- I 02. Signed informed consent prior to beginning protocol specific procedures.
- I 03. Patients with PSA >20 ng/mL at screening.
Key exclusion criteria (8 listed)
- E 01. Age <20 and >74
- E 02. ECOG performance status ≥2.
- E 03. Prior surgery ≤4 weeks of registration in the study.
- E 04. Active secondary cancer including prior malignancy from which the patient has been disease-free for ≤5 years (However, adequately treated superficial basal cell skin cancer before 4 weeks prior to registration can be eligible to the study)
- Neutrophils <2.0 x 109/L Platelets <100 x 109/L Hemoglobin <9.0 g/dL (transfusion prohibition within 14 days before registration) Creatinine >1.5 mg/dL. Total bilirubin >1.5 times the upper normal limits of the institutional norms ALT/AST >1.5 times the upper normal limits of the institutional norms
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 | Arm 1 |
| prednisolonePharmaceutical form:tablet Route of administration: oral | Drug | Arm 1 |
Primary outcome
Identification of maximum tolerated dose
Time frame: up to 18 months
3 secondary outcomes
number of participants with treatment emergent adverse events
Time frame: up to 18 months
Pharmakokinetic parameters of Cabazitaxel
Time frame: up to 18 months
Prostate Specific Antigen (PSA) Response
Time frame: up to 18 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 7 Jan 2015.
- Derived from this study: PubMed 25809824Nozawa M, Mukai H, Takahashi S, Uemura H, Kosaka T, Onozawa Y, Miyazaki J, Suzuki K, Okihara K, Arai Y, Kamba T, Kato M, Nakai Y, Furuse H, Kume H, Ide H, Kitamura H, Yokomizo A, Kimura T, Tomita Y, Ohno K, Kakehi Y. Japanese phase I study of cabazitaxel in metastatic castration-resistant prostate cancer. Int J Clin Oncol. 2015 Oct;20(5):1026-34. doi: 10.1007/s10147-015-0820-9. Epub 2015 Mar 26.
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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
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cabazitaxel (XRP6258) and prednisolone in people with Prostate Cancer, run by Sanofi at 21 sites in Japan.
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 8 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 7 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in Japan. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Identification of maximum tolerated dose (time frame: up to 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01324583, which also lists 1 linked publication.
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 7 Jan 2015.