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

Camarus

Status and phase: Completed; Phase 2

Conditions: Prostate Cancer

Treatments: Drug: leuprolide acetate FluidCrystal® injection depot; Drug: leuprolide acetate

Study type: Interventional

Funder types: Industry

Identifiers

NCT02212197

HS-12-460

Details and patient eligibility

About

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.

Enrollment: 51 patients

Sex: Male

Ages: 40 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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51 participants in 3 patient groups

CAM2032 3.75 mg

Experimental group

Description:

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

Treatment:

Drug: leuprolide acetate FluidCrystal® injection depot

CAM2032 7.5 mg

Experimental group

Description:

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

Treatment:

Drug: leuprolide acetate FluidCrystal® injection depot

Eligard 7.5 mg

Active Comparator group

Description:

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

Treatment:

Drug: leuprolide acetate