Clinical trial NCT01360840: EMD 525797 in Subjects With Asymptomatic or Mildly Symptomatic Metastatic Castrate-resistant Prostate Cancer
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer Metastatic
Keywords: Asymptomatic
mildly symptomatic
metastatic castrate-resistant prostate cancer
mCRPC
Lead sponsor: EMD Serono
Sponsor class: INDUSTRY
First posted: 2011-05-26
Enrollment: 180
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).


Eligibility 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 \[ng/dL\]) 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

Primary outcomes:
measure: Progression Free Survival (PFS) Time
timeFrame: Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years
Secondary outcomes:
measure: Overall Survival
timeFrame: Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years
measure: Time to Tumor Progression
timeFrame: Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years
measure: Number of Subjects With Presence of Tumor Response and Disease Control (DC) in Soft Tissue Lesions
timeFrame: Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years
measure: Number of Subjects With New Bone Lesions Compared to Baseline
timeFrame: Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years
measure: Number of Subjects With Presence of DC in Bone Lesions
timeFrame: At Weeks 13, 19 and 25
measure: Bone and Soft Tissue Lesions Composite Tumor Response
timeFrame: Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years
measure: Number of Subjects With Presence of Skeletal Related Events
timeFrame: Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years
measure: Number of Subjects With Presence of Prostate Specific Antigen (PSA) Response
timeFrame: Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years
measure: Minimum Percentage Change From Baseline in PSA Serum Concentration
timeFrame: Baseline, up to data cut-off date (30 April 2013), assessed up to 2 years
measure: Minimum Percentage Change From Baseline in the Number of Circulating Tumor Cells (CTCs)
timeFrame: Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years
measure: Overall Minimum Percentage Change From Previous Time Point in Circulating Tumor Cells (CTC)
timeFrame: 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
measure: Number of Subjects With Any Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Death, and TEAEs Leading to Discontinuation
timeFrame: 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
measure: Pharmacokinetic Parameter: Clearance of Intravenously Administered EMD 525797 After First Dose (CL) and Clearance in Steady State of EMD52597 After Fifth Dose (CLss)
timeFrame: 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
measure: 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
timeFrame: 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
Other outcomes:
measure: To Explore the Relationship Between Number and/or Changes of Numbers of Biomarker and the Clinical Outcome
timeFrame: From the date of randomization up to data cut-off date (30 April 2013), assessed up to 2 years
Locations:
city: Pleasant Hill
country: United States
facility: Research Site
state: California
city: Chicago
country: United States
facility: Research Site
state: Illinois
city: New Orleans
country: United States
facility: Research Site
state: Louisiana
city: Ann Arbor
country: United States
facility: Research Site
state: Michigan
city: Detroit
country: United States
facility: Research Site
state: Michigan
city: New Brunswick
country: United States
facility: Research Site
state: New Jersey
city: Cleveland
country: United States
facility: Research Site
state: Ohio
city: Dallas
country: United States
facility: Research Site
state: Texas
city: Houston
country: United States
facility: Research Site
state: Texas
city: Tyler
country: United States
facility: Research Site
state: Texas
city: Roanoke
country: United States
facility: Research Site
state: Virginia
city: Spokane
country: United States
facility: Research Site
state: Washington
city: Bendigo
country: Australia
facility: Research Site
city: Coffs Harbour
country: Australia
facility: Research Site
city: Darlinghurst
country: Australia
facility: Research Site
city: Frankston
country: Australia
facility: Research Site
city: Gosford
country: Australia
facility: Research Site
city: Kurralta Park
country: Australia
facility: Research Site
city: Northmead
country: Australia
facility: Research Site
city: Port Macquarie
country: Australia
facility: Research Site
city: Randwick
country: Australia
facility: Research Site
city: Turnhout
country: Australia
facility: Research Site
city: Antwerp
country: Belgium
facility: ZNA Middelheim Oncologie
city: Brantford
country: Canada
facility: Brandord Urology Research
state: Ontario
city: Abbotsford
country: Canada
facility: Exdeo Clinical Research Inc.
city: Province of British Columbia
country: Canada
facility: Can-Med Clinical Research Inc.
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
city: Victoria
country: Canada
facility: Research Site
city: Windsor
country: Canada
facility: Research Site
city: Angers
country: France
facility: Research Site
city: Bourgogne
country: France
facility: Center Alexis Vaurrin
city: Caen Cedex 05
country: France
facility: Research Site
city: Colmar
country: France
facility: Hôpitaux Civils de Colmar-CH Louis Pasteur
city: Paris
country: France
facility: Research Site
city: Reims
country: France
facility: Research Site
city: Villejuif
country: France
facility: Institute Gustave Roussy
city: Aachen
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Universitätsmedizin Charité, Campus Benjamin Franklin, Urologische Klinik and Poliklinik
city: Darmstadt
country: Germany
facility: Research Site
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus an der Techischen Universität Dresden, Klinik und Poliklinik für Urologie
city: Esslingen
country: Germany
facility: Research Site
city: Freiburg
country: Germany
facility: Research Site
city: Hannover
country: Germany
facility: Research Site
city: Nürtingen
country: Germany
facility: Research Site
city: Reutlingen
country: Germany
facility: Studienpraxis Urologie
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübinger, Klinik und Poliklinik für Urologie
city: Blaricum
country: Netherlands
facility: Research Site
city: Groningen
country: Netherlands
facility: Research Site
city: Haarlem
country: Netherlands
facility: Research Site
city: Gdańsk
country: Poland
facility: Research Site
city: Lublin
country: Poland
facility: Research Site
city: Łódź
country: Poland
facility: Research Site
city: Barnaul
country: Russian Federation
facility: Altay Regional Oncology Dispensary
city: Barnaul
country: Russian Federation
facility: Research Site
city: Ekaterinburg
country: Russian Federation
facility: Research Site
city: Ivanovo
country: Russian Federation
facility: State Institution of Healthcare Ivanovo Regional Oncology Dispensary
city: Izhevsk
country: Russian Federation
facility: Budzhet Clinical Oncology Center
city: Kazan
country: Russian Federation
facility: Research Site
city: Krasnoyarsk
country: Russian Federation
facility: Krasnoyarsk State Medical University Oncology and Radiotherapy Territorial Dispensary
city: Omsk
country: Russian Federation
facility: Research Site
city: Petersburg
country: Russian Federation
facility: City Hospital # 2
city: Stavropol
country: Russian Federation
facility: Research Site
city: Presov
country: Slovakia
facility: Research Site
city: Gauteng
country: South Africa
facility: Research Site
city: Kwa-Zulu Natal
country: South Africa
facility: Research Site
city: Pretoria Gauteng
country: South Africa
facility: Research Site
city: Western Cape
country: South Africa
facility: Research Site
city: Barcelone
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Pamplona
country: Spain
facility: Research Site
city: Sabadell, Barcelone
country: Spain
facility: Research Site
Study officials:
affiliation: EMD Serono Inc., an affiliate of Merck KGaA, Darmstadt, Germany
name: Medical Responsible
role: STUDY_DIRECTOR
References: