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Trial · Interventional

CompletedPhase 2Results postedRegistry data

Equivalence of Intramuscular (IM) Versus Subcutaneous (SC) Applications of Long Acting Pamorelin 11.25 mg

Short name PAMIS

NCTNCT01257425 (opens ClinicalTrials.gov in a new tab)Other idA-94-52014-178Other id2010-019632-12
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
109 participants (actual)
Sponsor
Ipsen · Industry
Design
Randomized · Open label (no masking)
Countries
1 country

Germany

Start
Dec 2010
Primary completion
Feb 2012
Completion
May 2012
First posted
9 Dec 2010 (estimated)
Last update posted
8 Feb 2019
Conditions
Prostate Cancer

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2010201120122013
  1. Ph 2

    PAMIS

    NCT01257425

    Dec 2010 to May 2012

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Triptorelin Pamoate (Pamorelin® LA 11.25 mg)Drug

Arms2

  • Other

    Triptorelin Pamoate (Pamorelin® LA 11.25 mg) IM.

  • Other

    Triptorelin Pamoate (Pamorelin® LA 11.25 mg) SC.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. 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

    Registry description

    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.

Secondary outcomes(6)

  1. 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

    Registry description

    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.

  2. 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

    Registry description

    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.

  3. 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

    Registry description

    Cmax was assessed as the maximum testosterone serum concentration between the first administration of the study drug and Day 169.

  4. 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

    Registry description

    Cmax was assessed as the maximum testosterone serum concentration between the first administration of the study drug and Day 169.

  5. Time to Castration [Tcast] - Testosterone Level Less Than or Equal to 0.5 ng/mL

    Time frame · 12 weeks

    Registry description

    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.

  6. Time to Castration [Tcast] - Testosterone Level Less Than 0.5 ng/mL

    Time frame · 12 weeks

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 1, 3, 5, 8, 15, 22, 29, 57, 85 days post-dose

Area Under the Curve of Testosterone Serum Concentration Between D1 and D85 (AUC1-85d).

GroupValue (log(ng*day/mL))Spread
Triptorelin Pamoate (Pamorelin® LA 11.25 mg) SC.4.240.40
Triptorelin Pamoate (Pamorelin® LA 11.25 mg) IM.4.230.50
Secondary and other outcome results(6)
Secondary outcomeMean· 1, 3, 5, 8, 15, 22, 29, 57, 85, 87, 113, 141 and 169 days post-dose

Area Under the Curve of Testosterone Serum Concentration Between D1 and D169 (AUC1-169d)

GroupValue (log(ng*day/mL))Spread
Triptorelin Pamoate (Pamorelin® LA 11.25 mg) SC.4.490.42
Triptorelin Pamoate (Pamorelin® LA 11.25 mg) IM.4.520.56
Secondary outcomeMean· 85, 87, 113, 141 and 169 days post-dose

Area Under the Curve of Testosterone Serum Concentration Between D85 and D169 (AUC85-169d)

GroupValue (log(ng*day/mL))Spread
Triptorelin Pamoate (Pamorelin® LA 11.25 mg) SC.2.800.45
Triptorelin Pamoate (Pamorelin® LA 11.25 mg) IM.2.880.38
Secondary outcomeMean· 1, 3, 5, 8, 15, 22, 29, 57, 85, 87, 113, 141 and 169 days post-dose

Maximum Concentration of Serum Testosterone [Cmax] - Raw Data

GroupValue (ng/mL)Spread
Triptorelin Pamoate (Pamorelin® LA 11.25 mg) SC.5.742.33
Triptorelin Pamoate (Pamorelin® LA 11.25 mg) IM.5.502.35
Secondary outcomeMean· 1, 3, 5, 8, 15, 22, 29, 57, 85, 87, 113, 141 and 169 days post-dose

Maximum Concentration of Serum Testosterone [Cmax] - Log-transformed Data

GroupValue (log(ng/mL))Spread
Triptorelin Pamoate (Pamorelin® LA 11.25 mg) SC.1.670.42
Triptorelin Pamoate (Pamorelin® LA 11.25 mg) IM.1.620.42
Secondary outcomeMedian· 12 weeks

Time to Castration [Tcast] - Testosterone Level Less Than or Equal to 0.5 ng/mL

GroupValue (days)
Triptorelin Pamoate (Pamorelin® LA 11.25 mg) SC.22.0
Triptorelin Pamoate (Pamorelin® LA 11.25 mg) IM.22.0
Secondary outcomeMedian· 12 weeks

Time to Castration [Tcast] - Testosterone Level Less Than 0.5 ng/mL

GroupValue (days)
Triptorelin Pamoate (Pamorelin® LA 11.25 mg) SC.22.0
Triptorelin Pamoate (Pamorelin® LA 11.25 mg) IM.22.0

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Triptorelin Pamoate (Pamorelin® LA 11.25 mg) SC.Subcutaneous (SC) application of triptorelin pamoate (Pamorelin LA 11.25 mg)administered on Day 1 and Day 85.–11 / 5232 / 52
Triptorelin Pamoate (Pamorelin® LA 11.25 mg) IM.Intramuscular (IM) application of triptorelin pamoate (Pamorelin LA 11.25 mg) administered on Day 1 and Day 85.–7 / 5125 / 51

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Male
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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 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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