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

Merck KGaA (EMD Serono)

Status and phase: Completed; Phase 2

Conditions: Prostate Cancer Metastatic

Treatments: Other: Standard of Care (SoC); Drug: EMD 525797; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01360840

EMR 62242-006

Details and patient eligibility

About

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).

Enrollment: 180 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 [ng/dL]) for subjects without surgical castration (luteinizing hormone-releasing hormone antagonists and agonists)
• Other protocol defined inclusion criteria could 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
• Other protocol defined exclusion criteria could apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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180 participants in 3 patient groups, including a placebo group

Placebo + Standard of care (SoC)

Placebo Comparator group

Treatment:

Other: Placebo

Other: Standard of Care (SoC)

EMD 525797 750 mg + SoC

Experimental group

Treatment:

Drug: EMD 525797

Other: Standard of Care (SoC)

Drug: EMD 525797

EMD 525797 1500 mg + SoC

Experimental group

Treatment:

Drug: EMD 525797

Other: Standard of Care (SoC)

Drug: EMD 525797