Overview

This trial has been completed.

Condition prostate cancer
Treatment leuprolide acetate
Phase phase 2
Sponsor Camurus AB
Start date September 2014
End date November 2015
Trial size 51 participants
Trial identifier NCT02212197, HS-12-460

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification pharmacokinetics/dynamics study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
CAM2032 (leuprolide acetate FluidCrystal® injection depot) q1m, 3.75 mg, subcutaneous injection once monthly, three months treatment
leuprolide acetate CAM2032 q1m
(Experimental)
CAM2032 (leuprolide acetate FluidCrystal injection depot) q1m, 7.5 mg, subcutaneous injection once monthly, three months treatment
leuprolide acetate CAM2032 q1m
(Active Comparator)
Eligard® (leuprolide acetate), 7.5 mg, subcutaneous injection once monthly, three months treatment
leuprolide acetate CAM2032 q1m

Primary Outcomes

Measure
CAM2032 q1m pharmacokinetic profile (plasma concentration)
time frame: 126 days

Secondary Outcomes

Measure
CAM2032 q1m effect on serum testosterone (s-T) concentration
time frame: 126 days
CAM2032 q1m effect on serum prostate specific antigen (PSA) levels
time frame: 126 days
Safety of repeat doses of CAM2032 q1m
time frame: 126 days

Eligibility Criteria

Male participants from 40 years up to 85 years old.

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

Additional Information

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
Principal investigator Teuvo Tammela, Professor
Trial information was received from ClinicalTrials.gov and was last updated in December 2016.
Information provided to ClinicalTrials.gov by Camurus AB.