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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01360840




Registration number
NCT01360840
Ethics application status
Date submitted
15/04/2011
Date registered
26/05/2011
Date last updated
14/12/2015

Titles & IDs
Public title
EMD 525797 in Subjects With Asymptomatic or Mildly Symptomatic Metastatic Castrate-resistant Prostate Cancer
Scientific 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)
Secondary ID [1] 0 0
EMR 62242-006
Universal Trial Number (UTN)
Trial acronym
PERSEUS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer Metastatic 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - EMD 525797
Treatment: Drugs - EMD 525797
Other interventions - Placebo
Other interventions - Standard of Care (SoC)

Placebo Comparator: Placebo + Standard of care (SoC) -

Experimental: EMD 525797 750 mg + SoC -

Experimental: EMD 525797 1500 mg + SoC -


Treatment: Drugs: EMD 525797
Subjects will be administered with EMD 525797 at a dose of 1500 milligram (mg) (diluted with 0.9 percent [%] sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons.

Treatment: Drugs: EMD 525797
Subjects will be administered with EMD 525797 at a dose of 750 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons.

Other interventions: Placebo
Subjects will be administered with placebo (as 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons.

Other interventions: Standard of Care (SoC)
All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists).
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression Free Survival (PFS) Time
Timepoint [1] 0 0
Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years
Secondary outcome [1] 0 0
Overall Survival
Timepoint [1] 0 0
Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years
Secondary outcome [2] 0 0
Time to Tumor Progression
Timepoint [2] 0 0
Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years
Secondary outcome [3] 0 0
Number of Subjects With Presence of Tumor Response and Disease Control (DC) in Soft Tissue Lesions
Timepoint [3] 0 0
Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years
Secondary outcome [4] 0 0
Number of Subjects With New Bone Lesions Compared to Baseline
Timepoint [4] 0 0
Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years
Secondary outcome [5] 0 0
Number of Subjects With Presence of DC in Bone Lesions
Timepoint [5] 0 0
At Weeks 13, 19 and 25
Secondary outcome [6] 0 0
Bone and Soft Tissue Lesions Composite Tumor Response
Timepoint [6] 0 0
Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years
Secondary outcome [7] 0 0
Number of Subjects With Presence of Skeletal Related Events
Timepoint [7] 0 0
Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years
Secondary outcome [8] 0 0
Number of Subjects With Presence of Prostate Specific Antigen (PSA) Response
Timepoint [8] 0 0
Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years
Secondary outcome [9] 0 0
Minimum Percentage Change From Baseline in PSA Serum Concentration
Timepoint [9] 0 0
Baseline, up to data cut-off date (30 April 2013), assessed up to 2 years
Secondary outcome [10] 0 0
Minimum Percentage Change From Baseline in the Number of Circulating Tumor Cells (CTCs)
Timepoint [10] 0 0
Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years
Secondary outcome [11] 0 0
Overall Minimum Percentage Change From Previous Time Point in Circulating Tumor Cells (CTC)
Timepoint [11] 0 0
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
Secondary outcome [12] 0 0
Number of Subjects With Any Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Death, and TEAEs Leading to Discontinuation
Timepoint [12] 0 0
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
Secondary outcome [13] 0 0
Pharmacokinetic Parameter: Clearance of Intravenously Administered EMD 525797 After First Dose (CL) and Clearance in Steady State of EMD52597 After Fifth Dose (CLss)
Timepoint [13] 0 0
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
Secondary outcome [14] 0 0
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
Timepoint [14] 0 0
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

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2014
Sample size
Target
Accrual to date
Final
180
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Bendigo
Recruitment hospital [2] 0 0
Research Site - Coffs Harbour
Recruitment hospital [3] 0 0
Research Site - Darlinghurst
Recruitment hospital [4] 0 0
Research Site - Frankston
Recruitment hospital [5] 0 0
Research Site - Gosford
Recruitment hospital [6] 0 0
Research Site - Kurralta Park
Recruitment hospital [7] 0 0
Research Site - Northmead
Recruitment hospital [8] 0 0
Research Site - Port Macquarie
Recruitment hospital [9] 0 0
Research Site - Randwick
Recruitment hospital [10] 0 0
Research Site - Turnhout
Recruitment postcode(s) [1] 0 0
- Bendigo
Recruitment postcode(s) [2] 0 0
- Coffs Harbour
Recruitment postcode(s) [3] 0 0
- Darlinghurst
Recruitment postcode(s) [4] 0 0
- Frankston
Recruitment postcode(s) [5] 0 0
- Gosford
Recruitment postcode(s) [6] 0 0
- Kurralta Park
Recruitment postcode(s) [7] 0 0
- Northmead
Recruitment postcode(s) [8] 0 0
- Port Macquarie
Recruitment postcode(s) [9] 0 0
- Randwick
Recruitment postcode(s) [10] 0 0
- Turnhout
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Illinois
Country [3] 0 0
United States of America
State/province [3] 0 0
Louisiana
Country [4] 0 0
United States of America
State/province [4] 0 0
Michigan
Country [5] 0 0
United States of America
State/province [5] 0 0
New Jersey
Country [6] 0 0
United States of America
State/province [6] 0 0
Ohio
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
Country [8] 0 0
United States of America
State/province [8] 0 0
Virginia
Country [9] 0 0
United States of America
State/province [9] 0 0
Washington
Country [10] 0 0
Belgium
State/province [10] 0 0
Antwerp
Country [11] 0 0
Canada
State/province [11] 0 0
Ontario
Country [12] 0 0
Canada
State/province [12] 0 0
Abbotsford
Country [13] 0 0
Canada
State/province [13] 0 0
Province of British Columbia
Country [14] 0 0
Canada
State/province [14] 0 0
Toronto
Country [15] 0 0
Canada
State/province [15] 0 0
Victoria
Country [16] 0 0
Canada
State/province [16] 0 0
Windsor
Country [17] 0 0
France
State/province [17] 0 0
Angers
Country [18] 0 0
France
State/province [18] 0 0
Bourgogne
Country [19] 0 0
France
State/province [19] 0 0
Caen Cedex 05
Country [20] 0 0
France
State/province [20] 0 0
Colmar
Country [21] 0 0
France
State/province [21] 0 0
Paris
Country [22] 0 0
France
State/province [22] 0 0
Reims
Country [23] 0 0
France
State/province [23] 0 0
Villejuif
Country [24] 0 0
Germany
State/province [24] 0 0
Aachen
Country [25] 0 0
Germany
State/province [25] 0 0
Berlin
Country [26] 0 0
Germany
State/province [26] 0 0
Darmstadt
Country [27] 0 0
Germany
State/province [27] 0 0
Dresden
Country [28] 0 0
Germany
State/province [28] 0 0
Esslingen
Country [29] 0 0
Germany
State/province [29] 0 0
Freiburg
Country [30] 0 0
Germany
State/province [30] 0 0
Hannover
Country [31] 0 0
Germany
State/province [31] 0 0
Nürtingen
Country [32] 0 0
Germany
State/province [32] 0 0
Reutlingen
Country [33] 0 0
Germany
State/province [33] 0 0
Tübingen
Country [34] 0 0
Netherlands
State/province [34] 0 0
Blaricum
Country [35] 0 0
Netherlands
State/province [35] 0 0
Groningen
Country [36] 0 0
Netherlands
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Haarlem
Country [37] 0 0
Poland
State/province [37] 0 0
Gdansk
Country [38] 0 0
Poland
State/province [38] 0 0
Lublin
Country [39] 0 0
Poland
State/province [39] 0 0
Lódz
Country [40] 0 0
Russian Federation
State/province [40] 0 0
Barnaul
Country [41] 0 0
Russian Federation
State/province [41] 0 0
Ekaterinburg
Country [42] 0 0
Russian Federation
State/province [42] 0 0
Ivanovo
Country [43] 0 0
Russian Federation
State/province [43] 0 0
Izhevsk
Country [44] 0 0
Russian Federation
State/province [44] 0 0
Kazan
Country [45] 0 0
Russian Federation
State/province [45] 0 0
Krasnoyarsk
Country [46] 0 0
Russian Federation
State/province [46] 0 0
Omsk
Country [47] 0 0
Russian Federation
State/province [47] 0 0
Petersburg
Country [48] 0 0
Russian Federation
State/province [48] 0 0
Stavropol
Country [49] 0 0
Slovakia
State/province [49] 0 0
Presov
Country [50] 0 0
South Africa
State/province [50] 0 0
Gauteng
Country [51] 0 0
South Africa
State/province [51] 0 0
Kwa-Zulu Natal
Country [52] 0 0
South Africa
State/province [52] 0 0
Pretoria Gauteng
Country [53] 0 0
South Africa
State/province [53] 0 0
Western Cape
Country [54] 0 0
Spain
State/province [54] 0 0
Barcelone
Country [55] 0 0
Spain
State/province [55] 0 0
Madrid
Country [56] 0 0
Spain
State/province [56] 0 0
Pamplona
Country [57] 0 0
Spain
State/province [57] 0 0
Sabadell, Barcelone

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
EMD Serono
Address
Country

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/ct2/show/NCT01360840
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Responsible
Address 0 0
EMD Serono Inc., an affiliate of Merck KGaA, Darmstadt, Germany
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01360840