A Phase 2 interventional study of leuprolide acetate FluidCrystal® injection depot and leuprolide acetate in Prostate Cancer, sponsored by Camurus AB. Completed at 7 sites in 2 countries. Open to male participants aged 40 Years to 85 Years. Per ClinicalTrials.gov, last updated 2017-04-25.
Sponsored by Camurus AB · Phase 2, Interventional, and Treatment
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.
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.
This study's enrollment of 51 is below the median of 60 across 5,348 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Camurus AB is the lead sponsor of 9 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
Single subcutaneous buttock injections of Eligard® (leuprolide acetate) 7.5 mg on Days 0, 28 and 56.
Drug: leuprolide acetate
Also known as: CAM2032
Also known as: Eligard
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).
Time frame: 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.
Time frame: 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.
Time frame: Days 0-28 and Days 56-84 (0-672 hours after Doses 1 and 3)
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.
Time frame: Days 56-126
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.
Time frame: 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.
Time frame: Days 0-126
| Milestone | CAM2032 3.75 mg | CAM2032 7.5 mg | Eligard 7.5 mg |
|---|---|---|---|
| Started | 19 | 15 | 17 |
| Completed | 18 | 15 | 17 |
| Not completed | 1 | 0 | 0 |
| Withdrew: Need for radiotherapy | 1 | 0 | 0 |
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).
| ng/mL | CAM2032 3.75 mg | CAM2032 7.5 mg | Eligard 7.5 mg |
|---|---|---|---|
| Dose 1 | 6.14 ± 41.1 | 9.66 ± 31.5 | 13.6 ± 54.7 |
| Dose 3 | 5.36 ± 33.3 | 11.3 ± 36.8 | 12.1 ± 47.3 |
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.
| hour | CAM2032 3.75 mg | CAM2032 7.5 mg | Eligard 7.5 mg |
|---|---|---|---|
| Dose 1 | 205 ± 113 | 231 ± 142 | 743 ± 1677 |
| Dose 3 | 299 ± 277 | 434 ± 867 | 378 ± 570 |
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.
| h*ng/mL | CAM2032 3.75 mg | CAM2032 7.5 mg | Eligard 7.5 mg |
|---|---|---|---|
| Dose 1 | 329 ± 37.6 | 622 ± 45.2 | 397 ± 45.3 |
| Dose 3 | 343 ± 24.7 | 757 ± 53.4 | 460 ± 62.2 |
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 | CAM2032 3.75 mg | CAM2032 7.5 mg | Eligard 7.5 mg |
|---|---|---|---|
| Time (Days) to Testosterone Recovery After Dose 3 | 46.2 ± 13.6 | 52.3 ± 20.6 | 65 ± 5.7 |
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.
| ng/dL | CAM2032 3.75 mg | CAM2032 7.5 mg | Eligard 7.5 mg |
|---|---|---|---|
| Day 0 (predose) | 443 (369 to 546) | 321 (269 to 439) | 350 (240 to 465) |
| Day 28 (predose) | 20.9 (18.3 to 47) | 24.5 (16.1 to 210) | 18.1 (11.1 to 28.1) |
| Day 56 (predose) | 14.6 (10.7 to 19.3) | 13.8 (7.8 to 22) | 12 (9.29 to 15) |
| Day 84 | 14.8 (9.17 to 27.6) | 10.6 (7.5 to 18.8) | 12.4 (9.92 to 13.8) |
| Day 126 | 423 (258 to 526) | 278 (124 to 470) | 85.8 (16 to 280) |
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.
| ng/mL | CAM2032 3.75 mg | CAM2032 7.5 mg | Eligard 7.5 mg |
|---|---|---|---|
| Day 0 (predose) | 14.9 (5.8 to 85.4) | 18.8 (9.6 to 93.5) | 14.6 (4.7 to 32.9) |
| Day 28 (predose) | 9 (2.8 to 19) | 8.3 (5.9 to 31.5) | 4.6 (2.3 to 8) |
| Day 56 (predose) | 3.6 (1.1 to 8.4) | 5.8 (1.1 to 11.2) | 2.1 (0.8 to 4.1) |
| Day 84 | 2.3 (1.1 to 5.6) | 2.6 (0.8 to 14) | 1.6 (0.4 to 2.7) |
| Day 126 | 4.7 (2.9 to 19.9) | 3.1 (1.5 to 19.1) | 1.6 (0.5 to 3.8) |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CAM2032 3.75 mg | — | 0/19 (0%) | 14/19 (73.7%) |
| CAM2032 7.5 mg | — | 1/15 (6.7%) | 12/15 (80%) |
| Eligard 7.5 mg | — | 0/17 (0%) | 10/17 (58.8%) |
| Event | CAM2032 3.75 mg | CAM2032 7.5 mg | Eligard 7.5 mg |
|---|---|---|---|
| DisorientationPsychiatric disorders | 0/19 | 1/15 | 0/17 |
| Calculus urinaryRenal and urinary disorders | 0/19 | 1/15 | 0/17 |
| Urinary tract infectionInfections and infestations | 0/19 | 1/15 | 0/17 |
| Event | CAM2032 3.75 mg | CAM2032 7.5 mg | Eligard 7.5 mg |
|---|---|---|---|
| Hot flushVascular disorders | 8/19 | 4/15 | 5/17 |
| NauseaGastrointestinal disorders | 4/19 | 0/15 | 0/17 |
| Back painMusculoskeletal and connective tissue disorders | 0/19 | 3/15 | 1/17 |
| InfluenzaInfections and infestations | 3/19 | 3/15 | 1/17 |
| HeadacheNervous system disorders | 0/19 | 1/15 | 3/17 |
| HypertensionVascular disorders | 3/19 | 1/15 | 0/17 |
| FallInjury, poisoning and procedural complications | 3/19 | 0/15 | 1/17 |
| Urinary retentionRenal and urinary disorders | 0/19 | 2/15 | 2/17 |
| NocturiaRenal and urinary disorders | 0/19 | 2/15 | 0/17 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 0/19 | 2/15 | 1/17 |
| Age, Categorical(Participants) | CAM2032 3.75 mg | CAM2032 7.5 mg | Eligard 7.5 mg | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 6 | 1 | 2 | 9 |
| >=65 years | 13 | 14 | 15 | 42 |
| Age, Continuous(years) | CAM2032 3.75 mg | CAM2032 7.5 mg | Eligard 7.5 mg | Total |
|---|---|---|---|---|
| Mean | 69.7 ± 9.5 | 71.9 ± 6.3 | 70.9 ± 7 | 70.8 ± 7.8 |
| Sex: Female, Male(Participants) | CAM2032 3.75 mg | CAM2032 7.5 mg | Eligard 7.5 mg | Total |
|---|---|---|---|---|
| Female | 0 | 0 | 0 | 0 |
| Male | 19 | 15 | 17 | 51 |
| Region of Enrollment(participants) | CAM2032 3.75 mg | CAM2032 7.5 mg | Eligard 7.5 mg | Total |
|---|---|---|---|---|
| Hungary | 6 | 5 | 9 | 20 |
| Finland | 13 | 10 | 8 | 31 |
The record gives a start of Sep 2014, a primary completion of Nov 2015 and a completion of Mar 2016. It does not say whether these dates are actual or estimated.
Results were first posted in Feb 2017, 1 year 3 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
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Camurus AB