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

April 15, 2011
May 13, 2014
April 2011
September 2014   (final data collection date for primary outcome measure)
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 ]
Progression Free Survival [ Time Frame: anticipated average time frame of 2 years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01360840 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 EMD525797 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 circulating tumor cells (CTCs) and the clinical outcome [ Time Frame: anticipated average time frame of 2 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
EMD 525797 in Subjects With Asymptomatic or Mildly Symptomatic Metastatic Castrate-resistant Prostate Cancer
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)

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).

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Prostate Cancer Metastatic
  • 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.
  • 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.
  • 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.
  • Experimental: Arm 1
    Intervention: Drug: EMD 525797
  • Experimental: Arm 2
    Intervention: Drug: EMD 525797
  • Placebo Comparator: Arm 3
    Intervention: Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
180
September 2014
September 2014   (final data collection date for primary outcome measure)

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
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Belgium,   Canada,   France,   Germany,   Netherlands,   Poland,   Russian Federation,   Slovakia,   South Africa,   Spain
 
NCT01360840
EMR 62242-006
Yes
EMD Serono
EMD Serono
Not Provided
Study Director: Medical Responsible EMD Serono Inc., an affiliate of Merck KGaA, Darmstadt, Germany
EMD Serono
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP