Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00004139

Trial Description

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Title

A Phase II, Multicentre, Open, Prospective, Randomised, Parallel-Group, Pharmacodynamic Equivalence Study on Intramuscular Versus Subcutaneous Applications of Triptorelin Pamoate (Pamorelin® LA 11.25 mg) in Patients With Advanced Prostate Cancer

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Trial Acronym

PAMIS

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URL of the Trial

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Brief Summary in Lay Language

The purpose of this study is to demonstrate the pharmacodynamic equivalence of triptorelin
pamoate (Pamorelin® LA 11.25 mg), applied either IM or SC, in terms of the area under the
curve [AUC1-85day] for serum testosterone in patients with advanced prostate cancer.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00004139
  •   2012/10/17
  •   2010/12/08
  •   no
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Secondary IDs

  •   2010-019632-12 
  •   NCT01257425  (ClinicalTrials.gov)
  •   A-94-52014-178  (Ipsen)
  •   2010-019632-12 
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Health Condition or Problem studied

  •   Prostate Cancer
  •   C61 -  Malignant neoplasm of prostate
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Interventions/Observational Groups

  •   Drug: Triptorelin Pamoate (Pamorelin® LA 11.25 mg)
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Treatment
  •   Parallel
  •   II
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Primary Outcome

- Area Under the Curve of Testosterone Serum Concentration Between D1 and D85 (AUC1-85d).; time frame: 1, 3, 5, 8, 15, 22, 29, 57, 85 days post-dose; Area under the curve (AUC) calculated from serum testosterone concentration taken at intervals between the first administration (Day 1) of the study drug and Day 85 after dosing. From the curve describing serum testosterone concentration levels (ng/mL) over time, the AUC was calculated using numerical integration methods. This value was log-transformed to more closely meet the assumption of the statistical method.

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Secondary Outcome

- Area Under the Curve of Testosterone Serum Concentration Between D1 and D169 (AUC1-169d); time frame: 1, 3, 5, 8, 15, 22, 29, 57, 85, 87, 113, 141 and 169 days post-dose; Area under the curve calculated from serum testosterone concentration taken at intervals between the first administration (Day 1) of the study drug and Day 169 after dosing. From the curve describing serum testosterone concentration levels (ng/mL) over time, the AUC was calculated using numerical integration methods. This value was log-transformed to more closely meet the assumption of the statistical method.
- Area Under the Curve of Testosterone Serum Concentration Between D85 and D169 (AUC85-169d); time frame: 85, 87, 113, 141 and 169 days post-dose; Area under the curve calculated from serum testosterone concentration taken at intervals between Day 85 and Day 169 after dosing. From the curve describing serum testosterone concentration levels (ng/mL) over time, the AUC was calculated using numerical integration methods. This value was log-transformed to more closely meet the assumption of the statistical method.
- Maximum Concentration of Serum Testosterone [Cmax] - Raw Data; time frame: 1, 3, 5, 8, 15, 22, 29, 57, 85, 87, 113, 141 and 169 days post-dose; Cmax was assessed as the maximum testosterone serum concentration between the first administration of the study drug and Day 169.
- Maximum Concentration of Serum Testosterone [Cmax] - Log-transformed Data; time frame: 1, 3, 5, 8, 15, 22, 29, 57, 85, 87, 113, 141 and 169 days post-dose; Cmax was assessed as the maximum testosterone serum concentration between the first administration of the study drug and Day 169.
- Time to Castration [Tcast] - Testosterone Level Less Than or Equal to 0.5 ng/mL; time frame: 12 weeks; tcast is the number of days between day of first administration of the study drug and the day the testosterone level reaches the limit of castration defined as testosterone level less than or equal to 0.5 ng/mL for the first time. Analysis of tcast was based on the Kaplan-Meier estimator.
- Time to Castration [Tcast] - Testosterone Level Less Than 0.5 ng/mL; time frame: 12 weeks; tcast is the number of days between day of first administration of the study drug and the day the testosterone level reaches the limit of castration defined as testosterone level less than 0.5 ng/mL for the first time. Analysis of tcast was based on the Kaplan-Meier estimator.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

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  •   2010/12/31
  •   102
  •   Multicenter trial
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Inclusion Criteria

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

- Histologically or cytologically proven prostate cancer, locally advanced or
metastatic, or rising PSA (prostate-specific antigen) after failed local therapy, and
the patient scheduled to receive androgen deprivation therapy

- Serum testosterone levels ≥ 125 ng/dl (1.25 ng/ml, 1.25 microg/l, 4.3 nmol/l)
measured by any laboratory or on site within the previous 6 months or at study start

- Karnofsky performance index > 70

- Expected survival ≥ 9 months

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Exclusion Criteria

- Prior hormonal treatment for prostate cancer including gonadotropin-releasing hormone
(GnRH) agonists or antagonists within the last 12 months preceding the study or
concomitant treatment with one or more of these substance(s)

- Any current use or within 6 months prior to treatment start of medications which are
known to affect the metabolism and/or secretion of androgenic hormones: ketoconazole,
aminoglutethimide, oestrogens and progesterone

- Patient at risk of spinal cord compression or ureter obstruction

- Prior hypophysectomy or adrenalectomy

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Addresses

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    • Ipsen
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    • Ipsen
    • Martin Gerwe, MD 
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    • Ipsen
    • Martin Gerwe, MD 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting complete, follow-up complete
  •   2012/05/01
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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 .
  •   4
  •   2016/01/14


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