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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
EMD Serono
ClinicalTrials.gov Identifier:
NCT01360840
First received: April 15, 2011
Last updated: May 13, 2014
Last verified: May 2014
  Purpose

The primary objective of the trial is to evaluate the clinical anti-tumor activity of EMD 525797 administered as 1-hour intravenous infusion every 3 weeks in terms of progression free survival (PFS) time in subjects with asymptomatic or mildly symptomatic metastatic castrate-resistant prostate cancer (mCRPC).


Condition Intervention Phase
Prostate Cancer Metastatic
Drug: EMD 525797
Other: Placebo
Phase 2

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
Official Title: A Randomized, Double-blind, Placebo-controlled, Multicenter Phase II Trial Investigating Two Doses of EMD 525797 in Subjects With Asymptomatic or Mildly Symptomatic Metastatic Castrate-resistant Prostate Cancer (mCRPC)

Resource links provided by NLM:


Further study details as provided by EMD Serono:

Primary Outcome Measures:
  • Clinical anti-tumor activity assessed as progression free survival (PFS) [ Time Frame: up to 3 months after last subject randomized ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: anticipated average time frame of 2 years ] [ Designated as safety issue: No ]
  • Time to progression [ Time Frame: anticipated average time frame of 2 years ] [ Designated as safety issue: Yes ]
  • PSA response [ Time Frame: anticipated average time frame of 2 years ] [ Designated as safety issue: No ]
  • Population pharmacokinetics data will be used to study of the sources of variability in drug concentrations among individuals which may have an impact on efficacy or safety of EMD 525797 such as CL (L/h) and Vd (L) [ Time Frame: anticipated average time frame of 2 years ] [ Designated as safety issue: Yes ]
  • Number of treatment emergent adverse events [ Time Frame: anticipated average time frame of 2 years ] [ Designated as safety issue: Yes ]
  • To explore the relationship between number and/or changes of numbers of biomarker and the clinical outcome [ Time Frame: anticipated average time frame of 2 years ] [ Designated as safety issue: No ]

Enrollment: 180
Study Start Date: April 2011
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: EMD 525797
All eligible subjects will receive EMD 525797 and will be given intravenous (1500 mg/1h infusion) every 3 weeks until disease progression.
Experimental: Arm 2 Drug: EMD 525797
All eligible subjects will receive EMD 525797 and will be given intravenous (750 mg/1h infusion) every 3 weeks until disease progression.
Placebo Comparator: Arm 3 Other: Placebo
The trial will be controlled using placebo (a 0.9% sodium chloride solution) plus Standard of care. If subjects experience radiographic progressive disease (PD) without symptoms (asymptomatic) or with mild symptoms (mildly symptomatic) neither requiring opioid therapy nor chemotherapy, they will be allowed to receive open-label treatment with EMD 525797, 1500 mg after radiographic confirmation by bone scintigraphy 6 weeks later. Until this confirmation, treatment will be continued as scheduled.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed adenocarcinoma of the prostate (Gleason score)
  • Bisphosphonate treatment
  • Stable, ongoing adequate testosterone suppression proven by hypogonadal levels of testosterone (less than or equal to 50 nanogram per deciliter) for subjects without surgical castration (luteinizing hormone-releasing hormone antagonists and agonists)
  • Additional inclusion criteria also apply

Exclusion Criteria:

  • Prior chemotherapy, biologic therapy (targeted therapy), or any experimental therapy for mCRPC
  • Chronic and ongoing treatment with opioids
  • Acute pathologic fracture, spinal cord compression, or hypercalcemia at Screening
  • Visceral metastasis, brain metastasis
  • Radiotherapy to bone lesions and/or orthopedic surgery for pathologic fractures. Any kinds of major elective surgery within 30 days prior to trial treatment
  • Additional exclusion criteria also apply
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01360840

  Show 71 Study Locations
Sponsors and Collaborators
EMD Serono
Investigators
Study Director: Medical Responsible EMD Serono Inc., an affiliate of Merck KGaA, Darmstadt, Germany
  More Information

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
Last Updated: May 13, 2014
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

Keywords provided by EMD Serono:
Asymptomatic
mildly symptomatic
metastatic castrate-resistant prostate cancer
mCRPC

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on September 30, 2014