Phase II Study of Subcutaneous Injection Depot of Leuprolide Acetate in Patient With Prostate Cancer

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02212197
• Other study ID #: HS-12-460
• Status: Completed
• Phase: Phase 2
• First received: August 5, 2014
• Last updated: December 6, 2016
• Start date: September 2014
• Est. completion date: March 2016

Study information

• Verified date: December 2016
• Source: Camurus AB
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines AgencyHungary: National Institute of Pharmacy
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: March 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• leuprolide acetate

Locations

Country	Name	City	State
Finland	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
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

Sponsors (1)

Lead Sponsor	Collaborator
Camurus AB

Countries where clinical trial is conducted

Finland,  Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CAM2032 q1m pharmacokinetic profile (plasma concentration)		126 days	No
Secondary	CAM2032 q1m effect on serum testosterone (s-T) concentration		126 days	No
Secondary	CAM2032 q1m effect on serum prostate specific antigen (PSA) levels		126 days	No
Secondary	Safety of repeat doses of CAM2032 q1m	Number of treatment-emergent adverse events	126 days	Yes