Primary outcomeGeometric mean· 84 days
Observed Maximum Serum Leuprolide Concentration (Cmax) for Dose 1 and Dose 3
| Group | Value (ng/mL) | Spread |
|---|---|---|
| CAM2032 3.75 mg | 6.14 | 41.1 |
| CAM2032 7.5 mg | 9.66 | 31.5 |
| Eligard 7.5 mg | 13.6 | 54.7 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataPhase II Study of Subcutaneous Injection Depot of Leuprolide Acetate in Patient With Prostate Cancer
NCTNCT02212197 (opens ClinicalTrials.gov in a new tab)Other idHS-12-460
Overview
- Status
- Completed
- Phase
- Phase 2
- Enrollment
- 51 participants (actual)
- Sponsor
- Camurus AB · Industry
- Design
- Randomized · Open label (no masking)
- Countries
2 countries
Finland, Hungary
- Start
- Sept 2014
- Primary completion
- Nov 2015
- Completion
- Mar 2016
- First posted
- 8 Aug 2014 (estimated)
- Last update posted
- 25 Apr 2017
- Conditions
- Prostate Cancer
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
2014201520162017
- Ph 2
Phase II Study of Subcutaneous Injection Depot of Leuprolide Acetate in Patient With Prostate Cancer
NCT02212197Sept 2014 to Mar 2016
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- leuprolide acetate FluidCrystal® injection depotDrug
- leuprolide acetateDrug
Arms3
Experimental
CAM2032 3.75 mg
Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 3.75 mg on Days 0, 28 and 56.
Experimental
CAM2032 7.5 mg
Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 7.5 mg on Days 0, 28 and 56.
Active comparator
Eligard 7.5 mg
Single subcutaneous buttock injections of Eligard® (leuprolide acetate) 7.5 mg on Days 0, 28 and 56.
Primary outcomes3
Outcomes the sponsor listed as primary.
Observed Maximum Serum Leuprolide Concentration (Cmax) for Dose 1 and Dose 3
Time frame · 84 days
Registry description
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).
Apparent Terminal Half-life (t½) for Dose 1 and Dose 3
Time frame · Days 0-28 and Days 56-84
Registry description
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.
Area Under the Serum Concentration-time Curve (AUC) Over the Dosing Interval (AUCtau) for Dose 1 and Dose 3
Time frame · Days 0-28 and Days 56-84 (0-672 hours after Doses 1 and 3)
Registry description
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.
Secondary outcomes(3)
Time (Days) to Testosterone Recovery After Dose 3
Time frame · Days 56-126
Registry description
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.
Profiles of Testesterone Concentration (ng/dL) Following Injections of the Investigational Medicinal Product (IMP)
Time frame · Days 0-126
Registry description
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.
Mean Prostate Specific Antigen (PSA) Concentration
Time frame · Days 0-126
Registry description
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.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Primary outcomeMean· Days 0-28 and Days 56-84
Apparent Terminal Half-life (t½) for Dose 1 and Dose 3
| Group | Value (hour) | Spread |
|---|---|---|
| CAM2032 3.75 mg | 205 | 113 |
| CAM2032 7.5 mg | 231 | 142 |
| Eligard 7.5 mg | 743 | 1677 |
Primary outcomeGeometric mean· Days 0-28 and Days 56-84 (0-672 hours after Doses 1 and 3)
Area Under the Serum Concentration-time Curve (AUC) Over the Dosing Interval (AUCtau) for Dose 1 and Dose 3
| Group | Value (h*ng/mL) | Spread |
|---|---|---|
| CAM2032 3.75 mg | 329 | 37.6 |
| CAM2032 7.5 mg | 622 | 45.2 |
| Eligard 7.5 mg | 397 | 45.3 |
Secondary and other outcome results(3)
Secondary outcomeMean· Days 56-126
Time (Days) to Testosterone Recovery After Dose 3
| Group | Value (days) | Spread |
|---|---|---|
| CAM2032 3.75 mg | 46.2 | 13.6 |
| CAM2032 7.5 mg | 52.3 | 20.6 |
| Eligard 7.5 mg | 65 | 5.7 |
Secondary outcomeMedian· Days 0-126
Profiles of Testesterone Concentration (ng/dL) Following Injections of the Investigational Medicinal Product (IMP)
| Group | Value (ng/dL) |
|---|---|
| CAM2032 3.75 mg | 443 |
| CAM2032 7.5 mg | 321 |
| Eligard 7.5 mg | 350 |
Secondary outcomeMedian· Days 0-126
Mean Prostate Specific Antigen (PSA) Concentration
| Group | Value (ng/mL) |
|---|---|
| CAM2032 3.75 mg | 14.9 |
| CAM2032 7.5 mg | 18.8 |
| Eligard 7.5 mg | 14.6 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| CAM2032 3.75 mgSingle subcutaneous buttock injections of CAM2032 3.75 mg on Days 0, 28 and 56. | – | 0 / 19 | 14 / 19 |
| CAM2032 7.5 mgSingle subcutaneous buttock injections of CAM2032 7.5 mg on Days 0, 28 and 56. | – | 1 / 15 | 12 / 15 |
| Eligard 7.5 mgSingle subcutaneous buttock injections of Eligard 7.5 mg on Days 0, 28 and 56. | – | 0 / 17 | 10 / 17 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- Male
- Age
- from 40 Years up to 85 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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
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