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

NCT02212197 | Completed Phase 2 Results

• 1 other identifier: HS-12-460
• Study Type: interventional
• Target: 51
• Locations: 2 countries
• Sites: 7

Brief Summary

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.

Conditions

Prostate Cancer

Keywords

prostate cancer; leuprolide

Outcome Measures

Primary Outcomes (3)

• Observed Maximum Serum Leuprolide Concentration (Cmax) for Dose 1 and Dose 3

  Blood samples for analysis of serum leuprolide concentrations were collected at pre-determined time points throughout the trial (with full PK profiles after Dose 1 and Dose 3). The PK parameter, Cmax was derived for Doses 1 and 3 of the investigational medicinal product (IMP).

  84 days

• Apparent Terminal Half-life (t½) for Dose 1 and Dose 3

  Blood samples for analysis of serum leuprolide concentrations were collected at pre-determined time points throughout the trial (with full PK profiles after Dose 1 and Dose 3). The PK parameter, t1/2 was derived for Doses 1 and 3 of the IMP.

  Days 0-28 and Days 56-84

• Area Under the Serum Concentration-time Curve (AUC) Over the Dosing Interval (AUCtau) for Dose 1 and Dose 3

  Blood samples for analysis of serum leuprolide concentrations were collected at pre-determined time points throughout the trial (with full PK profiles after Dose 1 and Dose 3). The PK parameter, AUCtau was derived for Doses 1 and 3 of the IMP.

  Days 0-28 and Days 56-84 (0-672 hours after Doses 1 and 3)

Secondary Outcomes (3)

• Time (Days) to Testosterone Recovery After Dose 3

  Days 56-126

• Profiles of Testesterone Concentration (ng/dL) Following Injections of the Investigational Medicinal Product (IMP)

  Days 0-126

• Mean Prostate Specific Antigen (PSA) Concentration

  Days 0-126

Study Arms (3)

CAM2032 3.75 mg

EXPERIMENTAL

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

Drug: leuprolide acetate FluidCrystal® injection depot

CAM2032 7.5 mg

EXPERIMENTAL

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

Drug: leuprolide acetate FluidCrystal® injection depot

Eligard 7.5 mg

ACTIVE COMPARATOR

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

Drug: leuprolide acetate

Interventions

leuprolide acetate FluidCrystal® injection depot DRUG

Also known as: CAM2032

CAM2032 3.75 mg; CAM2032 7.5 mg

leuprolide acetate DRUG

Also known as: Eligard

Eligard 7.5 mg

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Camurus AB: lead

Study Sites (7)

Docrates Cancer Center

Helsinki, Finland

Location

University Hospital of Helsinki, Department of Urology

Helsinki, Finland

Location

Tampere University Hospital, Department of Urology

Tampere, Finland

Location

University Hospital of Turku, Department of Urology

Turku, Finland

Location

Semmelweis University Hospital Department of Urology

Budapest, Hungary

Location

Szent Imre Teaching Hospital

Budapest, Hungary

Location

University of Debrecen, Medical Health Sciences Center, Department of Urology

Debrecen, Hungary

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Leuprolide; luprolide acetate gel depot

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Results Point of Contact

• Title: Clinical Trial Manager
• Organization: Camurus AB

info@camurus.com

Study Officials

• Teuvo Tammela, Prof

  Tampere University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2014
• First Posted: August 8, 2014
• Study Start: September 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: March 1, 2016
• Last Updated: April 25, 2017
• Results First Posted: February 6, 2017

Record last verified: 2017-03

Locations

FI (4); HU (3)