Overview

This trial is active, not recruiting.

Condition prostate cancer metastatic
Treatments emd 525797, placebo
Phase phase 2
Sponsor EMD Serono
Start date April 2011
End date September 2014
Trial size 180 participants
Trial identifier NCT01360840, EMR 62242-006

Summary

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
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)
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)
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.

Primary Outcomes

Measure
Clinical anti-tumor activity assessed as progression free survival (PFS)
time frame: up to 3 months after last subject randomized

Secondary Outcomes

Measure
Overall survival
time frame: anticipated average time frame of 2 years
Time to progression
time frame: anticipated average time frame of 2 years
PSA response
time frame: anticipated average time frame of 2 years
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
Number of treatment emergent adverse events
time frame: anticipated average time frame of 2 years
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

Eligibility Criteria

Male participants at least 18 years old.

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

Additional Information

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)
Trial information was received from ClinicalTrials.gov and was last updated in May 2014.
Information provided to ClinicalTrials.gov by EMD Serono.