Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00009664

Trial Description

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Title

A Randomized, Open Label Multi-Center Study of XRP6258 at 25 mg/m^2 in Combination With Prednisone Every 3 Weeks Compared to Mitoxantrone in Combination With Prednisone For The Treatment of Hormone Refractory Metastatic Prostate Cancer Previously Treated With A Taxotere®-Containing Regimen

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Trial Acronym

TROPIC

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URL of the Trial

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Brief Summary in Lay Language

This is a randomized, open-label, multi-center study comparing the safety and efficacy of
XRP6258 plus prednisone to mitoxantrone plus prednisone in the treatment of hormone
refractory metastatic prostate cancer previously treated with a Taxotere®-containing
regimen. The primary objective is overall survival. Secondary objectives include progression
free survival, overall response rate, prostate-specific antigen (PSA) response/progression,
pain response/progression, overall safety, and pharmacokinetics. Patients will be treated
until disease progression, death, unacceptable toxicity, or for a maximum of 10 cycles.
Patients will have long-term follow-up for a maximum of up to 2 years.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00009664
  •   2015/11/12
  •   2006/12/28
  •   no
  •   [---]*
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Secondary IDs

  •   NCT00417079  (ClinicalTrials.gov)
  •   EFC6193  (Sanofi)
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Health Condition or Problem studied

  •   Neoplasms
  •   Prostatic Neoplasms
  •   C61 -  Malignant neoplasm of prostate
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Interventions/Observational Groups

  •   Drug: cabazitaxel (XRP6258) (RPR116258)
  •   Drug: mitoxantrone
  •   Drug: prednisone
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   III
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Primary Outcome

- Overall Survival; time frame: From the date of randomization up to 104 weeks (study cut-off); Overall survival was defined as the time interval from the date of randomization to the date of death due to any cause.
In the absence of confirmation of death, the survival time was censored at the last date patient was known to be alive or at the cut-off date, whichever had come first.

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Secondary Outcome

- Time to Progression Free Survival (PFS); time frame: From the date of randomization up to 104 weeks (study cut-off); Progression free survival was defined as a composite endpoint evaluated from the date of randomization to the date of tumor progression, PSA progression, pain progression, or death due to any cause, whichever occurred first
- Overall Tumor Response; time frame: From the date of randomization up to 104 weeks (study cut-off); Tumor Overall Response Rate (ORR) (only in patients with measurable disease):
Objective responses (Complete Response and Partial Response) for measurable disease as assessed by investigators according to RECIST criteria.
Complete Response (CR) is defined as: Disappearance of all target lesions. Partial Response (PR) is defined as: At least a 30% decrease in the sum of longest diameter (LD) of target lesions taking as reference baseline sum LD.
Confirmation of objective responses will be performed by repeat tumor imaging (CT scans, MRI, bone scans) after the first documentation of response.
- Time to Tumor Progression; time frame: From the date of randomization up to 104 weeks (study cut-off); Time to tumor progression is defined as the number of months from randomization until evidence of progressive disease (RECIST)
- Time to Prostatic Specific Antigen (PSA) Progression; time frame: at screening, day 1 of every treatment cycle, up to 104 weeks (study cut-off); In PSA non-responders, progression will be defined as a 25% increase over nadir and increase in the absolute value PSA level by at least 5 ng/ml and confirmed by a second value at least 4 weeks later.
In PSA responders and in patients not evaluable for PSA response at baseline, progression will be defined as a ≥50% increase over nadir, provided that the increase is a minimum of 5 ng/ml and confirmed by a second value at least 1 week later.
- PSA (Prostate-Specific Antigen) Response; time frame: from baseline up to 104 weeks (study cut-off); PSA response was defined as a ≥ 50% reduction in serum PSA, determined only for patients with a serum PSA ≥ 20ng/mL at baseline, confirmed by a repeat PSA ≥ 3 weeks later.
- Time to Pain Progression; time frame: from baseline up to 104 weeks (study cut-off); Pain Progression is defined as an increase of ≥1 point in the median Personal Pain Intensity (PPI) from its nadir noted on 2 consecutive 3-week-apart visits or ≥25 % increase in the mean analgesic score compared with the baseline score & noted on 2 consecutive 3-week-apart visits or requirement for local palliative radiotherapy.
Evaluation of the PPI & analgesic scores are based on the short-form McGill Pain Questionnaire which consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0=none (best) 1=mild 2=moderate 3=severe (worst) (TOTAL: 0=best 45=worst)
- Pain Response; time frame: from baseline up to 104 weeks (study cut-off); Pain Response was defined as a two-point or greater reduction from baseline median Present Pain Intensity (PPI) score without an increased Analgesic Score (AS) or a decrease of ≥50% in the AS without an increase in the PPI score, maintained for at least 3 weeks.

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Countries of Recruitment

  •   Argentina
  •   Belgium
  •   Brazil
  •   Canada
  •   Chile
  •   Czech Republic
  •   Denmark
  •   Finland
  •   France
  •   Germany
  •   Hungary
  •   India
  •   Italy
  •   Korea, Republic of
  •   Mexico
  •   Netherlands
  •   Russian Federation
  •   Singapore
  •   Slovakia
  •   South Africa
  •   Spain
  •   Sweden
  •   Taiwan, Province of China
  •   Turkey
  •   United Kingdom
  •   United States
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Locations of Recruitment

  •  
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Recruitment

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  •   2007/01/31
  •   755
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Male
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Inclusion Criteria

1. Histologically or cytologically confirmed adenocarcinoma of the prostate that is
refractory to hormone therapy and previously treated with a Taxotere®-containing
regimen.

2. Documented progression of disease (demonstrating at least one visceral or soft tissue
metastatic lesion, including a new lesion). Patients with non-measurable disease must
have documented rising prostate-specific antigen (PSA) levels or appearance of new
lesion.

3. Surgical or hormone-induced castration

4. Life expectancy > 2 months

5. Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2

Exclusion criteria

1. Previous treatment with mitoxantrone

2. Previous treatment with <225 mg/m^2 cumulative dose of Taxotere (or docetaxel)

3. Prior radiotherapy to ≥ 40% of bone marrow

4. Surgery, radiation, chemotherapy, or other anti-cancer therapy within 4 weeks prior
to enrollment in the study

5. Other prior malignancy, except for adequately treated superficial basal cell skin
cancer, or any other cancer from which the patient has been disease-free for less
than 5 years

6. Known brain or leptomeningeal involvement

7. Other concurrent serious illness or medical conditions

8. Inadequate organ function evidenced by unacceptable laboratory results

The investigator will evaluate whether there are other reasons why a patient may not
participate.

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Exclusion Criteria

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Addresses

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    • Sanofi
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    • Sanofi
    • ICD 
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    • Sanofi
    • ICD 
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Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting complete, follow-up complete
  •   2009/09/01
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   2
  •   2016/07/17


* This entry means the parameter is not applicable or has not been set.