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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Eligard 7.5 mg | Active Comparator | Single subcutaneous buttock injections of Eligard® (leuprolide acetate) 7.5 mg on Days 0, 28 and 56. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| leuprolide acetate FluidCrystal® injection depot | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Time (Days) to Testosterone Recovery After Dose 3 | The pharmacodynamic (PD) effects of leuprolide were assessed by measuring serum testosterone during the trial. Time to testosterone recovery after last dose of the IMP. Blood samples for analyses of serum testosterone concentrations were collected at Screening and on Days 0 to 126. | Days 56-126 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Teuvo Tammela, Prof | Tampere University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Docrates Cancer Center | Helsinki | Finland | ||||
| University Hospital of Helsinki, Department of Urology |
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| ID | Title | Description |
|---|---|---|
| FG000 | CAM2032 3.75 mg | Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 3.75 mg on Days 0, 28 and 56. |
| FG001 | CAM2032 7.5 mg | Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 7.5 mg on Days 0, 28 and 56. |
| FG002 | Eligard 7.5 mg | Single subcutaneous buttock injections of Eligard® 7.5 mg on Days 0, 28 and 56. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CAM2032 3.75 mg | Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 3.75 mg on Days 0, 28 and 56. |
| BG001 | CAM2032 7.5 mg | Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 7.5 mg on Days 0, 28 and 56. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | The Per-Protocol Set (PPS) consisted of all randomized participants in the safety population who had a complete PK profile. In the CAM2032 3.75 mg group 15 of the 19 randomized participants were included in the PPS. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 84 days |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CAM2032 3.75 mg | Single subcutaneous buttock injections of CAM2032 3.75 mg on Days 0, 28 and 56. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Disorientation | Psychiatric disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hot flush | Vascular disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Manager | Camurus AB | info@camurus.com |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D016729 | Leuprolide |
| C493311 | luprolide acetate gel depot |
| ID | Term |
|---|---|
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
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| leuprolide acetate |
| Drug |
|
|
| Profiles of Testesterone Concentration (ng/dL) Following Injections of the Investigational Medicinal Product (IMP) | The PD effects of leuprolide were assessed by measuring serum testosterone concentrations during the trial. The following PD variable was analyzed: The profiles of testosterone concentration (ng/dL) following injections of the IMP. Blood samples for analyses of serum testosterone concentrations were collected at Screening and on Days 0 to 126. | Days 0-126 |
| Mean Prostate Specific Antigen (PSA) Concentration | The PD effects of leuprolide were assessed by measuring serum PSA concentrations during the trial. The following PD variable was analyzed: PSA (ng/mL) response to IMP. Blood samples for analyses of plasma PSA concentrations were collected at Screening and on Days 0 to 126. | Days 0-126 |
| Helsinki |
| Finland |
| Tampere University Hospital, Department of Urology | Tampere | Finland |
| University Hospital of Turku, Department of Urology | Turku | Finland |
| 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 | Hungary |
| BG002 | Eligard 7.5 mg | Single subcutaneous buttock injections of Eligard® 7.5 mg on Days 0, 28 and 56. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 |
| CAM2032 7.5 mg |
Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 7.5 mg on Days 0, 28 and 56. |
| OG002 | Eligard 7.5 mg | Single subcutaneous buttock injections of Eligard® 7.5 mg on Days 0, 28 and 56. |
|
|
| Primary | 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. | The Per-Protocol Set (PPS) consisted of all randomized participants in the safety population who had a complete PK profile. In the CAM2032 3.75 mg group 15 of the 19 randomized participants were included in the PPS. | Posted | Mean | Standard Deviation | hour | Days 0-28 and Days 56-84 |
|
|
|
| Primary | 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. | The Per-Protocol Set (PPS) consisted of all randomized participants in the safety population who had a complete PK profile. In the CAM2032 3.75 mg group 15 of the 19 randomized participants were included in the PPS. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | Days 0-28 and Days 56-84 (0-672 hours after Doses 1 and 3) |
|
|
|
| Secondary | Time (Days) to Testosterone Recovery After Dose 3 | The pharmacodynamic (PD) effects of leuprolide were assessed by measuring serum testosterone during the trial. Time to testosterone recovery after last dose of the IMP. Blood samples for analyses of serum testosterone concentrations were collected at Screening and on Days 0 to 126. | The Per-Protocol Set (PPS) consisted of all randomized participants in the safety population who had a complete PK profile. In the CAM2032 3.75 mg group 15 of the 19 randomized participants were included in the PPS. | Posted | Mean | Standard Deviation | days | Days 56-126 |
|
|
|
| Secondary | Profiles of Testesterone Concentration (ng/dL) Following Injections of the Investigational Medicinal Product (IMP) | The PD effects of leuprolide were assessed by measuring serum testosterone concentrations during the trial. The following PD variable was analyzed: The profiles of testosterone concentration (ng/dL) following injections of the IMP. Blood samples for analyses of serum testosterone concentrations were collected at Screening and on Days 0 to 126. | The Per-Protocol Set (PPS) consisted of all randomized participants in the safety population who had a complete PK profile. In the CAM2032 3.75 mg group 15 of the 19 randomized participants were included in the PPS. | Posted | Median | Inter-Quartile Range | ng/dL | Days 0-126 |
|
|
|
| Secondary | Mean Prostate Specific Antigen (PSA) Concentration | The PD effects of leuprolide were assessed by measuring serum PSA concentrations during the trial. The following PD variable was analyzed: PSA (ng/mL) response to IMP. Blood samples for analyses of plasma PSA concentrations were collected at Screening and on Days 0 to 126. | The Per-Protocol Set (PPS) consisted of all randomized participants in the safety population who had a complete PK profile. In the CAM2032 3.75 mg group 15 of the 19 randomized participants were included in the PPS. | Posted | Median | Inter-Quartile Range | ng/mL | Days 0-126 |
|
|
|
| 0 |
| 19 |
| 14 |
| 19 |
| EG001 | CAM2032 7.5 mg | Single subcutaneous buttock injections of CAM2032 7.5 mg on Days 0, 28 and 56. | 1 | 15 | 12 | 15 |
| EG002 | Eligard 7.5 mg | Single subcutaneous buttock injections of Eligard 7.5 mg on Days 0, 28 and 56. | 0 | 17 | 10 | 17 |
| Calculus urinary | Renal and urinary disorders |
|
| Urinary tract infection | Infections and infestations |
|
| Hypertension | Vascular disorders |
|
| Haematoma | Vascular disorders |
|
| Pyrexia | General disorders |
|
| Injection site erythema | General disorders |
|
| Fatigue | General disorders |
|
| Injection site nodule | General disorders |
|
| Oedema peripheral | General disorders |
|
| Pain | General disorders |
|
| Insomnia | Psychiatric disorders |
|
| Depressed mood | Psychiatric disorders |
|
| Prostatic pain | Reproductive system and breast disorders |
|
| Erectile dysfunction | Reproductive system and breast disorders |
|
| Genital pain | Reproductive system and breast disorders |
|
| Fall | Injury, poisoning and procedural complications |
|
| Ligament sprain | Injury, poisoning and procedural complications |
|
| Muscle strain | Injury, poisoning and procedural complications |
|
| Blood creatine phosphokinase increased | Investigations |
|
| Gamma-glutamyltransferase increased | Investigations |
|
| Alanine aminotransferase increased | Investigations |
|
| Blood glucose increased | Investigations |
|
| C-reactive protein increased | Investigations |
|
| Angina pectoris | Cardiac disorders |
|
| Arrhytmia | Cardiac disorders |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders |
|
| Headache | Nervous system disorders |
|
| Sciatica | Nervous system disorders |
|
| Syncope | Nervous system disorders |
|
| Vision blurred | Eye disorders |
|
| Conjunctival haemorrhage | Eye disorders |
|
| Eye pain | Eye disorders |
|
| Nausea | Gastrointestinal disorders |
|
| Diarrhoea | Gastrointestinal disorders |
|
| Inguinal hernia | Gastrointestinal disorders |
|
| Dry mouth | Gastrointestinal disorders |
|
| Urinary retention | Renal and urinary disorders |
|
| Haematuria | Renal and urinary disorders |
|
| Nocturia | Renal and urinary disorders |
|
| Haemorrhage urinary tract | Renal and urinary disorders |
|
| Micturition | Renal and urinary disorders |
|
| Bladder pain | Renal and urinary disorders |
|
| Incontinence | Renal and urinary disorders |
|
| Urethral pain | Renal and urinary disorders |
|
| Eczema | Skin and subcutaneous tissue disorders |
|
| Back pain | Musculoskeletal and connective tissue disorders |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders |
|
| Arthralgia | Musculoskeletal and connective tissue disorders |
|
| Muscle spasm | Musculoskeletal and connective tissue disorders |
|
| Intervertebral disc disorder | Musculoskeletal and connective tissue disorders |
|
| Myalgia | Musculoskeletal and connective tissue disorders |
|
| Neck pain | Musculoskeletal and connective tissue disorders |
|
| Bone pain | Musculoskeletal and connective tissue disorders |
|
| Bursitis | Musculoskeletal and connective tissue disorders |
|
| Groin pain | Musculoskeletal and connective tissue disorders |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders |
|
| Hypercholesterolaemia | Metabolism and nutrition disorders |
|
| Influenza | Infections and infestations |
|
| Abscess | Infections and infestations |
|
| Bronchitis | Infections and infestations |
|
| Gastroenteritis | Infections and infestations |
|
| Localised infection | Infections and infestations |
|
| Nasopharyngitis | Infections and infestations |
|
| Sinusitis | Infections and infestations |
|
| Gastroenteritis viral | Infections and infestations |
|
| Herpes zoster | Infections and infestations |
|
| Upper respiratory tract infection | Infections and infestations |
|
| Blood urine | Investigations |
|
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
|
|
|
| Day 56 (predose) |
|
| Day 84 |
|
| Day 126 |
|
|
| Day 56 (predose) |
|
| Day 84 |
|
| Day 126 |
|