Study on Efficacy, Pharmacokinetics, and Safety of Two Subcutaneous Injections of Triptorelin Embonate 6 Month Formulation in Patients With Advanced Prostate Cancer

This study has been completed.
Sponsor:
Collaborator:
Quintiles
Information provided by (Responsible Party):
Debiopharm International SA
ClinicalTrials.gov Identifier:
NCT01656161
First received: July 31, 2012
Last updated: January 31, 2014
Last verified: January 2014
  Purpose

The study will investigate the efficacy, pharmacokinetics and safety of triptorelin embonate 22.5 mg 6-month formulation administered by subcutaneous injections in patients with prostate cancer


Condition Intervention Phase
Prostate Cancer
Drug: Triptorelin embonate 22.5 mg
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicentre, Open, Non-comparative, Phase III Study on the Efficacy, Pharmacokinetics, and Safety of Two Subcutaneous Injections of Triptorelin Embonate 22.5 mg 6-month Formulation in Patients With Advanced Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Debiopharm International SA:

Primary Outcome Measures:
  • Primary Efficacy [ Time Frame: Month 1 (Day 29) and from Month 2 (Day 57) to end of Month 12 (Day 337) ] [ Designated as safety issue: No ]
    1. Percentage of patients achieving castrate levels of serum testosterone (< 1.735 nmol/L) by Day 29.
    2. Percentage of patients maintaining castrate levels of serum testosterone (< 1.735 nmol/L) from Month 2 (Day 57) to end of Month 12 (Day 337).


Secondary Outcome Measures:
  • Secondary efficacy [ Time Frame: Day 1 to Day 337 ] [ Designated as safety issue: Yes ]

    Secondary Efficacy

    1. Proportion of patients showing ≤ 1.0 IU/L increase in serum LH from 0 hour to 2 hours post-injection of first and second IMP injection.
    2. Percentage changes in PSA from baseline throughout treatment.
    3. Percentage of patients who show testosterone levels ≥ 1.735 nmol/L after the second injection (AOC).

    PK/PD (subset of 15 patients)

    1. Testosterone PD metrics in subset of 15 patients: AUC1-169d, Cmax, tmax, tcast.
    2. Triptorelin PK metrics in subset of 15 patients (for both injection periods): AUC1-169d, AUC169-337d, Cmax, tmax.


Enrollment: 120
Study Start Date: July 2012
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Triptorelin embonate 22.5 mg
Two consecutive injections of triptorelin pamoate 22.5 mg at an interval of 24 weeks
Drug: Triptorelin embonate 22.5 mg
Two consecutive injections of triptorelin pamoate 22.5 mg at an interval of 24 weeks
Other Name: Pamorelin

Detailed Description:

The study will investigate the efficacy, pharmacokinetics and safety of two subcutaneous injections of triptorelin embonate 22.5 mg 6-month formulation in patients with prostate cancer. The total duration of the study per patient will be 12 months (48 weeks)

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically proven prostate cancer.
  • Prostate cancer stage T3-4NxMx, TxN1Mx or TxNxM1 according to the TNM classification (see Appendix A: TNM Classification) or the patient should have rising PSA after failed local therapy and be candidate for androgen deprivation therapy.
  • Serum testosterone levels > 5 nmol/L.
  • Karnofsky performance index > 40 (see Appendix B: Karnofsky Performance Scale).
  • Expected survival > 18 months.
  • Absence of another malignancy, other than local dermatological, for the previous 5 years.
  • Signed informed consent before entry into the study.

Exclusion Criteria:

  • Prior hormonal treatment for prostate cancer within 6 months prior to study start.
  • Use of finasteride (Proscar®) or dutasteride (Avodart®/Avolve®) within 2 months prior to study start.
  • Presence of another neoplastic lesion or brain metastases.
  • Prior hypophysectomy or adrenalectomy.
  • Known or suspicion of vertebral metastases with risk of spinal compression.
  • Severe kidney or liver failure (creatinine > 2 x upper limit of normal (ULN), aspartate aminotransferase (ASAT) and alanine aminotransferase (ALAT) > 3 x ULN).
  • Any concomitant disorder or resulting therapy that is likely to interfere with patient compliance or with the study in the opinion of the Investigator.
  • Participation in another study with an experimental drug within 3 months before study start or within 5 drug half-lives of the investigational drug (whichever is the longer).
  • Known hypersensitivity to any of the test materials or related compounds.
  • Known active use of recreational drug or alcohol dependence in the opinion of the Investigator.
  • Any current use or use 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, progesterone, and anti-androgens.
  • Use of systemic or inhaled corticosteroids (topical application permitted).
  • Inability to give informed consent or to comply fully with the protocol.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01656161

Locations
South Africa
Wilmed Park Hospital
Klerksdorp, North West Province, South Africa, 2571
New Grootte Schuur Hospital, Division of Urology
Cape Town, South Africa, 7925
Vergelegen Medi-Clinic
Cape Town, South Africa, 7130
Department of Urology, Tygerberg Hospital
Cape Town, South Africa, 7505
Paarl Medical Centre
Cape Town, South Africa, 7646
Dr JCM Bahlmann
Eastern Cape, South Africa, 6530,
Clinical Trial Unit, Room 2-54, Prinshof Medical Campus
Gauteng, South Africa, 0002
Clinresco Centres (Pty) Ltd
Gauteng, South Africa, 1619
Pretoria Urology Hospital
Gauteng, South Africa, 0083
East Rand Urology Research Unit, Clinix Private Clinic
Johannesburg, South Africa, 1475
Sponsors and Collaborators
Debiopharm International SA
Quintiles
Investigators
Study Director: Eija Lundstrom, MD Debiopharm SA
Principal Investigator: Johann C. M. Bahlmann, MD
Principal Investigator: Richard Barnes, Pr New Grootte Schuur Hospital
Principal Investigator: MC Bigalke, MD Vergelegen Medi-Clinic
Principal Investigator: TJ Botha, MD Clinresco Centres (Pty) Ltd
Principal Investigator: Lance Coetzee, MD Pretoria Urology Hospital
Principal Investigator: T. Madlala, MD East Rand Urology Research Unit, Clinix Private Clinic
Principal Investigator: E Moshokoa, MD Clinical Trial Unit, Room 2-54, Prinshof Medical Campus
Principal Investigator: SG Smit, MD Department of Urology, Tygerberg Hospital
Principal Investigator: E Strasheim, MD Paarl Medical Centre
Principal Investigator: Cle Van Der Walt, MD Suite 207, Wilmed Park Hospital
  More Information

Additional Information:
Publications:
Responsible Party: Debiopharm International SA
ClinicalTrials.gov Identifier: NCT01656161     History of Changes
Other Study ID Numbers: Debio 8206-SC-301, KRA75538
Study First Received: July 31, 2012
Last Updated: January 31, 2014
Health Authority: South Africa: Medicines Control Council

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Triptorelin Pamoate
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on August 28, 2014