Phase II Study of Subcutaneous Injection Depot of Leuprolide Acetate in Patient With Prostate Cancer
Information source: Camurus AB
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Prostate Cancer
Intervention: leuprolide acetate (Drug)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: Camurus AB Official(s) and/or principal investigator(s): Teuvo Tammela, Professor, Principal Investigator, Affiliation: Tampere University Hospital, Department of Urology
Summary
The purpose of this study is to assess the pharmacokinetics, pharmacodynamics, efficacy and
safety of CAM2032 q1m versus Eligard, in patients with prostate cancer. All patients will
receive leuprolide acetate administered subcutaneously once monthly during 3 months.
Clinical Details
Official title: A Phase II, Open Label, Active Control, Multi-National, Multi-Centre, Randomized, Parallel Group Study Assessing Pharmacokinetics, Pharmacodynamics, Efficacy and Safety of CAM2032 q1m (Leuprolide Acetate FluidCrystal® Injection Depot Once Monthly) After Repeat Doses of 3.75 mg and 7.5 mg of Leuprolide Acetate vs. Eligard® 7.5 mg in Patients With Prostate Cancer
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: CAM2032 q1m pharmacokinetic profile (plasma concentration)
Secondary outcome: CAM2032 q1m effect on serum testosterone (s-T) concentrationCAM2032 q1m effect on serum prostate specific antigen (PSA) levels Safety of repeat doses of CAM2032 q1m
Eligibility
Minimum age: 40 Years.
Maximum age: 85 Years.
Gender(s): Male.
Criteria:
Inclusion Criteria:
- Men ≥40 and ≤85 years of age
- Histological or cytological proven adenocarcinoma of the prostate requiring hormone
therapy
- Life expectancy over 12 months
- World Health Organisation/ The Eastern Cooperative Oncology Group (WHO/ECOG)
performance status of 0, 1 or 2
- Adequate and stable renal function
- Adequate and stable hepatic function
Exclusion Criteria:
- Evidence of brain metastasis, spinal cord compression, or urinary tract obstruction
- S-T levels below 150 ng/dL at Screening visit
- Medical or radiological prostate cancer treatments within 2 months prior to the
Screening visit
- Surgical treatment of prostate cancer within 2 weeks prior to the Screening visit
- Known hypersensitivity to luteinizing hormone releasing hormone (LHRH) agonists or
other components of CAM2032 q1m or Eligard 7. 5 mg
- Prior orchiectomy, hypophysectomy, or adrenalectomy
- Prior use of LHRH agonists within 12 months prior to the Screening visit and during
the study
Locations and Contacts
Docrates Cancer Center, Helsinki, Finland
University Hospital of Helsinki, Department of urology, Helsinki, Finland
Tampere University Hospital, Department of Urology, Tampere, Finland
University Hospital of Turku, Department of urology, Turku, Finland
National Institute of Oncology Department of Chemotherapy C and Clinical Pharmacology, Budapest, Hungary
Semmelweis University Hospital Department of Urology, Budapest, Hungary
Szent Imre Teaching Hospital, Budapest, Hungary
University of Debrecen, Medical Health Sciences Center, Department of Urology, Debrecen, Hungary
B..A.Z County Teaching Hospital, Institute of Radiotherapy and Clinical Oncology, Miskolc, Hungary
Additional Information
Starting date: September 2014
Last updated: July 3, 2015
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