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Study to Assess the Non-Inferiority of Pamorelin® 11,25mg SC Injected Versus Pamorelin® 11,25mg IM Injected in Patients Suffering From Advanced Prostate Cancer (PAMOJECT)

Basic Trial Information
Trial Description
Summary
Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase
Type
Status
Age
Sponsor
Protocol IDs

Phase II

Treatment

Temporarily closed

18 and over

Pharmaceutical / Industry

I-48-52014-142
NCT00444639

Trial Description

Summary

The active ingredient of Pamorelin® 11,25 mg is Triptorelin. Triptorelin is a substitute for a natural hormone produced in the body called Gonadotrophin-releasing hormone (GnRH). GnRH is a hormone secreted by hypothalamus (a gland located in brain) and controls the production of sex hormones (eg testosterone in men) in other organs in the body. The growth of prostate cancer cells, one of the most common cancers in men, is induced by the hormone testosterone. Hormono-therapy is one of treatments available to treat this type of disease by controlling the testosterone serum level. Pamorelin® 11,25 mg is normally injected in the muscle but this type of injection is not suitable for every patient. Therefore the primary purpose of this study is to assess the non-inferiority of the 12-week triptorelin formulation Pamorelin® 11,25 mg administered via subcutaneous (SC) injection as compared to Pamorelin® 11,25 mg administered via standard intramuscular (IM) injection based on the percentage of patients presenting a testosterone level ≤ 50 ng/dl at week 24.

Eligibility Criteria

Inclusion Criteria:

Histological proven prostate cancer, locally advanced or metastatic and scheduled to receive hormonal deprivation therapy

Life expectancy of more than 9 months

Documented testosterone levels of ≥ 125 ng/dl measured by any laboratory or on site within the previous 6 months

Exclusion Criteria:

Has a history of hypersensitivity to the Investigational Medicinal Product or drugs with a similar chemical structure

Has previously received a GnRH analogue, estrogens or a steroidal anti -androgen within the last year preceding the study

Concomitant anti-coagulation treatment

Patient who underwent an orchidectomy or who is scheduled to receive an orchidectomy during the course of this study

Patient with known spinal medullar compression

Trial Contact Information

Trial Lead Organizations/Sponsors

Beaufour Ipsen International SNC

Danny D'hulster, MD

Study Director

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00444639
Information obtained from ClinicalTrials.gov on June 27, 2008

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.