EMD 525797 in Subjects With Asymptomatic or Mildly Symptomatic Metastatic Castrate-resistant Prostate Cancer (PERSEUS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
EMD Serono
ClinicalTrials.gov Identifier:
NCT01360840
First received: April 15, 2011
Last updated: November 9, 2015
Last verified: November 2015
Results First Received: July 24, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Prostate Cancer Metastatic
Interventions: Drug: EMD 525797
Other: Placebo
Other: Standard of Care (SoC)

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
First/Last subject (informed consent): April 2011/December 2012. Study completion date: July 2014. Clinical data cut-off: 30 April 2013. Subjects were recruited in 11 countries (Australia, Belgium, Canada, France, Germany, Netherlands, Poland, Russia, South Africa, Spain, and USA) across the globe in 65 centers.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Enrolled: 283 screened for eligibility; 103 were excluded (mainly non-fulfillment of inclusion or exclusion criteria). 180 subjects were assigned to the treatment groups. Two subjects did not receive study drug administration.

Reporting Groups
  Description
Placebo + SoC Subjects were administered with placebo 0.9% sodium chloride as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the standard of care (SoC) consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
EMD 525797 750 mg + SoC Subjects were administered with EMD 525797 at a dose of 750 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
EMD 525797 1500 mg + SoC Subjects were administered with EMD 525797 at a dose of 1500 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.

Participant Flow:   Overall Study
    Placebo + SoC     EMD 525797 750 mg + SoC     EMD 525797 1500 mg + SoC  
STARTED     60     60     60  
COMPLETED     50     50     51  
NOT COMPLETED     10     10     9  
Ongoing at data cut-off                 10                 10                 9  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All Subjects (ALL) analysis set included subjects who signed the Informed consent document.

Reporting Groups
  Description
Placebo + SoC Subjects were administered with placebo 0.9% sodium chloride as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
EMD 525797 750 mg + SoC Subjects were administered with EMD 525797 at a dose of 750 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
EMD 525797 1500 mg + SoC Subjects were administered with EMD 525797 at a dose of 1500 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
Total Total of all reporting groups

Baseline Measures
    Placebo + SoC     EMD 525797 750 mg + SoC     EMD 525797 1500 mg + SoC     Total  
Number of Participants  
[units: participants]
  60     60     60     180  
Age  
[units: years]
Mean (Standard Deviation)
  69.9  (8.43)     69.0  (7.31)     70.0  (8.88)     69.6  (8.20)  
Gender  
[units: Subjects]
       
Female     0     0     0     0  
Male     60     60     60     180  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Progression Free Survival (PFS) Time   [ Time Frame: Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years ]

2.  Secondary:   Overall Survival   [ Time Frame: Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years ]

3.  Secondary:   Time to Tumor Progression   [ Time Frame: Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years ]

4.  Secondary:   Number of Subjects With Presence of Tumor Response and Disease Control (DC) in Soft Tissue Lesions   [ Time Frame: Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years ]

5.  Secondary:   Number of Subjects With New Bone Lesions Compared to Baseline   [ Time Frame: Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years ]

6.  Secondary:   Number of Subjects With Presence of DC in Bone Lesions   [ Time Frame: At Weeks 13, 19 and 25 ]

7.  Secondary:   Bone and Soft Tissue Lesions Composite Tumor Response   [ Time Frame: Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years ]

8.  Secondary:   Number of Subjects With Presence of Skeletal Related Events   [ Time Frame: Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years ]

9.  Secondary:   Number of Subjects With Presence of Prostate Specific Antigen (PSA) Response   [ Time Frame: Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years ]

10.  Secondary:   Minimum Percentage Change From Baseline in PSA Serum Concentration   [ Time Frame: Baseline, up to data cut-off date (30 April 2013), assessed up to 2 years ]

11.  Secondary:   Minimum Percentage Change From Baseline in the Number of Circulating Tumor Cells (CTCs)   [ Time Frame: Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years ]

12.  Secondary:   Overall Minimum Percentage Change From Previous Time Point in Circulating Tumor Cells (CTC)   [ Time Frame: Cycle 1, Day 1 (Week 1): pre-dose, Cycle 3, Day 1 (Week 7): pre-dose, and Cycle 5, Day 1 (Week 13): pre-dose ]

13.  Secondary:   Number of Subjects With Any Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Death, and TEAEs Leading to Discontinuation   [ Time Frame: From the first dose of study drug administration until 50 days after the last dose of study drug administration or until cut-off date (30 April 2013), assessed up to 2 years ]

14.  Secondary:   Pharmacokinetic Parameter: Clearance of Intravenously Administered EMD 525797 After First Dose (CL) and Clearance in Steady State of EMD52597 After Fifth Dose (CLss)   [ Time Frame: Cycle 1 (Week 1) and cycle 5 (Week 13): Day 1: pre-dose, End of Infusion (EOI), 4, 8, 24, 48, 96, 168, 336, and 504 hours after start of infusion; Cycles 3 and 4 (Weeks 7 and 10), Day 1: pre-dose; Cycle 7 (Week 19), Day 1: pre-dose and EOI ]

15.  Secondary:   Pharmacokinetic Parameter: Volume of Distribution of EMD 525797 After the First Dose (V) and in Steady State After the Fifth Dose (Vss) of Intravenous Infusion   [ Time Frame: Cycle 1 (Week 1) and cycle 5 (Week 13): Day 1: pre-dose, End of Infusion (EOI), 4, 8, 24, 48, 96, 168, 336, and 504 hours after start of infusion; Cycles 3 and 4 (Weeks 7 and 10), Day 1: pre-dose; Cycle 7 (Week 19), Day 1: pre-dose and EOI ]

16.  Other Pre-specified:   To Explore the Relationship Between Number and/or Changes of Numbers of Biomarker and the Clinical Outcome   [ Time Frame: From the date of randomization up to data cut-off date (30 April 2013), assessed up to 2 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Merck KGaA Communication Center
Organization: Merck Serono, a division of Merck KGaA
phone: +49-6151-72-5200
e-mail: service@merckgroup.com


No publications provided


Responsible Party: EMD Serono
ClinicalTrials.gov Identifier: NCT01360840     History of Changes
Other Study ID Numbers: EMR 62242-006
Study First Received: April 15, 2011
Results First Received: July 24, 2015
Last Updated: November 9, 2015
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
Belgium: All Ethics Committees involved (1 per site)
Germany: Ethics Commission
Germany: Paul-Ehrlich-Institut
Poland: Lead Ethics Committee
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products - this organization act as reviewer in the name of Ministry of Health.
France: Institutional Ethical Committee
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France : Commission Nationale d'Informatique et des Libertés (CNIL) = French Data Protection Authority if applicable
France : Comité de Protection des Personnes (CPP) = Consultative Ethical Committee
France : Commission Nationale de l'Ordre des Médecins (CNOM) = French Board of Pysicians.
France : Hospital Internal Review Board if applicable
Russia: Ministry of Health and Social Development of Russian Federation
Russia: Ethics Council of The Ministry of Health and Social Development of Russian Federation
Russia: Scientific Center on Expertise of Medical Application Products of The Ministry of Health and Social Development of Russian Federation
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Netherlands: Medical Ethics Review Committee (METC)
Netherlands: Local Ethics Committee (1 per site)
Canada: Ethics Committees
Canada: Health Canada
United States: Food and Drug Administration
United States: Institutional Review Board
Spain: Ministry of Health
Spain: Ministry of Health and Consumption
Slovakia: State Institute for Drug Control
Australia: Department of Health and Ageing Therapeutic Goods Administration
Australia: Human Research Ethics Committee
Australia: National Health and Medical Research Council
South Africa: Department of Health
South Africa: Human Research Ethics Committee
South Africa: Medicines Control Council
South Africa: National Health Research Ethics Council