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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2016-03-31

Brief Summary

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The purpose of this study is to assess the pharmacokinetics, pharmacodynamics, efficacy and safety of CAM2032 versus Eligard, in patients with prostate cancer. All patients will receive leuprolide acetate administered subcutaneously once monthly during 3 months.

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Detailed Description

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Conditions

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Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CAM2032 3.75 mg

Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 3.75 mg on Days 0, 28 and 56.

Group Type EXPERIMENTAL

leuprolide acetate FluidCrystal® injection depot

Intervention Type DRUG

CAM2032 7.5 mg

Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 7.5 mg on Days 0, 28 and 56.

Group Type EXPERIMENTAL

leuprolide acetate FluidCrystal® injection depot

Intervention Type DRUG

Eligard 7.5 mg

Single subcutaneous buttock injections of Eligard® (leuprolide acetate) 7.5 mg on Days 0, 28 and 56.

Group Type ACTIVE_COMPARATOR

leuprolide acetate

Intervention Type DRUG

Interventions

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leuprolide acetate FluidCrystal® injection depot

Intervention Type DRUG

leuprolide acetate

Intervention Type DRUG

Other Intervention Names

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CAM2032 Eligard

Eligibility Criteria

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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
* Serum Testosterone 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
* Prior orchiectomy, hypophysectomy, or adrenalectomy
* Prior use of LHRH agonists within 12 months prior to the Screening visit and during the study

Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No