Prostate Cancer MetastaticPhase 2PERSEUSNCT01360840
EMD 525797 in Subjects With Asymptomatic or Mildly Symptomatic Metastatic Castrate-resistant Prostate Cancer
A Phase 2 study testing EMD 525797 in people with Prostate Cancer Metastatic, run by EMD Serono at 71 sites in 12 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer Metastatic
- What is being tested?
- EMD 525797
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 71 sitesin 12 countries
- Study dates
- Apr 2011to Jul 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
71 sites in 12 countries.
71 sites in 12 countries
United States12 sites
Research Site
Ann Arbor, Michigan
Research Site
Chicago, Illinois
Research Site
Cleveland, Ohio
Research Site
Dallas, Texas
Research Site
Detroit, Michigan
Research Site
Houston, Texas
Research Site
New Brunswick, New Jersey
Research Site
New Orleans, Louisiana
Research Site
Pleasant Hill, California
Research Site
Roanoke, Virginia
Research Site
Spokane, Washington
Research Site
Tyler, Texas
Australia10 sites
Research Site
Bendigo
Research Site
Coffs Harbour
Research Site
Darlinghurst
Research Site
Frankston
Research Site
Gosford
Research Site
Kurralta Park
Research Site
Northmead
Research Site
Port Macquarie
Research Site
Randwick
Research Site
Turnhout
Germany10 sites
Research Site
Aachen
Universitätsmedizin Charité, Campus Benjamin Franklin, Urologische Klinik and Poliklinik
Berlin
Research Site
Darmstadt
Universitätsklinikum Carl Gustav Carus an der Techischen Universität Dresden, Klinik und Poliklinik für Urologie
Dresden
Research Site
Esslingen am Neckar
Research Site
Freiburg im Breisgau
Research Site
Hanover
Research Site
Nürtingen
Studienpraxis Urologie
Reutlingen
Universitätsklinikum Tübinger, Klinik und Poliklinik für Urologie
Tübingen
Russia10 sites
Altay Regional Oncology Dispensary
Barnaul
Research Site
Barnaul
State Institution of Healthcare Ivanovo Regional Oncology Dispensary
Ivanovo
Budzhet Clinical Oncology Center
Izhevsk
Research Site
Kazan'
Krasnoyarsk State Medical University Oncology and Radiotherapy Territorial Dispensary
Krasnoyarsk
Research Site
Omsk
City Hospital # 2
Saint Petersburg
Research Site
Stavropol
Research Site
Yekaterinburg
France7 sites
Research Site
Angers
Center Alexis Vaurrin
Bourgogne
Research Site
Caen
Hôpitaux Civils de Colmar-CH Louis Pasteur
Colmar
Research Site
Paris
Research Site
Reims
Institute Gustave Roussy
Villejuif
Canada6 sites
Exdeo Clinical Research Inc.
Abbotsford British Columbia
Brandord Urology Research
Brantford, Ontario
Can-Med Clinical Research Inc.
Province of British Columbia
Sunnybrook Health Sciences Centre
Toronto
Research Site
Victoria
Research Site
Windsor
South Africa4 sites
Research Site
Gauteng
Research Site
Kwa-Zulu Natal
Research Site
Pretoria Gauteng
Research Site
Western Cape
Spain4 sites
Research Site
Barcelona
Research Site
Madrid
Research Site
Pamplona
Research Site
Sabadell, Barcelone
Netherlands3 sites
Research Site
Blaricum
Research Site
Groningen
Research Site
Haarlem
About this study
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)
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).
- Conditions
- Prostate Cancer Metastatic
- Being tested
- EMD 525797, Placebo, Standard of Care (SoC)
- Keywords
- Asymptomatic, mildly symptomatic, metastatic castrate-resistant prostate cancer, mCRPC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMD 525797Drug
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.
EMD 525797Drug
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.
PlaceboOther
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.
Standard of Care (SoC)Other
All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists).
| Study group | Role | What they receive |
|---|---|---|
| Placebo + Standard of care (SoC) | Placebo comparator | Not described Receives: Other: Placebo; Other: Standard of Care (SoC) |
| EMD 525797 750 mg + SoC | Experimental | Not described Receives: Drug: EMD 525797; Other: Standard of Care (SoC) |
| EMD 525797 1500 mg + SoC | Experimental | Not described Receives: Drug: EMD 525797; Other: Standard of Care (SoC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS) Time
PFS was defined as time from randomization until the first documented sign of objective radiographic disease progression (ORDP) or death from any cause. Death was considered as an event only if it was reported within 12 weeks after last tumor assessment without progression. ORDP was defined as: Bone lesion progression (2 or more new bone lesions compared to baseline) assessed with bone scintigraphy. Assessment was based on Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST v1.0) modified as per Prostate Cancer Working Group 2 (PCWG-2); Soft-tissue lesion progression assessed with CT scans according to RECIST v1.0 modified as per PCWG-2; Presence of skeletal events defined as cord compression/fracture documented via a scheduled or unscheduled radiographic assessment triggered by increased pain or other signs and/or symptoms, based on the investigator's discretion; Non-radiological events, including emergency bone irradiation and surgery, were not investigated.
Measured: Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years
Secondary outcomes (14)
Overall Survival
Overall Survival was defined as the time from the date of randomization to the date of death from any cause.
Measured: Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years
Time to Tumor Progression
Time to tumor progression was defined as the time from the date of randomization to the date of ORDP. ORDP was defined as: Bone lesion progression (2 or more new bone lesions compared to baseline) assessed with bone scintigraphy, which had to be confirmed by bone scintigraphy 6 weeks later if subjects remained asymptomatic or mildly symptomatic. Assessments were to be based on RECIST v1.0 modified according to PCWG-2; Soft-tissue lesion progression assessed with CT scans according to RECIST v1.0 modified as per PCWG-2; Presence of skeletal events defined as cord compression or fracture documented via a scheduled or unscheduled radiographic assessment triggered by increased pain or other signs and/or symptoms, based on the investigator's discretion; Non-radiological events, including emergency bone irradiation and surgery, were not investigated.
Measured: Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years
Number of Subjects With Presence of Tumor Response and Disease Control (DC) in Soft Tissue Lesions
Presence of tumor response in soft tissue lesions was defined as the presence of at least 1 confirmed complete response (CR) or confirmed partial response (PR) in soft tissue lesions, documented by computed tomography (CT) scans. Presence of DC in soft tissue lesions was defined as the presence of at least 1 confirmed CR or confirmed PR or stable disease (SD) lasting at least 12 weeks after randomization. Tumor response assessments were based on RECIST v1.0 modified according to the PCWG-2. The response was evaluated for subjects with measurable disease at baseline. According to RECIST v1.0, CR=disappearance of all target and non-target lesions; PR=at least 30% decrease in the sum of the longest diameter of target lesions and non-complete response/non-progressive disease in non-target lesions.
Measured: Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years
Number of Subjects With New Bone Lesions Compared to Baseline
New bone lesions were evaluated by bone scintigraphy for subjects with bone lesions at baseline.
Measured: Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years
Number of Subjects With Presence of DC in Bone Lesions
Presence of DC in bone lesions was defined as the appearance of less than 2 new bone lesions, documented by bone scintigraphy.
Measured: At Weeks 13, 19 and 25
Bone and Soft Tissue Lesions Composite Tumor Response
Bone and soft tissue lesions composite tumor response was defined as the presence of both a confirmed CR or PR, documented by CT scans, and a DC in bone lesions, documented by bone scintigraphy. CR was defined as disappearance of all target and non-target lesions and PR was defined as at least 30% decrease in the sum of the longest diameter of target lesions and non-complete response/non-progressive disease in non-target lesions. Presence of DC in bone lesions was defined as the appearance of less than 2 new bone lesions.
Measured: Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years
Number of Subjects With Presence of Skeletal Related Events
Presence of skeletal related events was defined as cord compression or fracture documented via a scheduled or unscheduled radiographic assessment triggered by increased pain or other signs and/or symptoms at the investigator discretion. Non-radiological events, including emergency bone irradiation and surgery, were not investigated.
Measured: Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years
Number of Subjects With Presence of Prostate Specific Antigen (PSA) Response
PSA response was defined as a decrease greater than 50 percent (%) in PSA value from baseline for 2 consecutive evaluations greater than or equal to (>=) 3 Weeks apart.
Measured: Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years
Minimum Percentage Change From Baseline in PSA Serum Concentration
Measured: Baseline, up to data cut-off date (30 April 2013), assessed up to 2 years
Minimum Percentage Change From Baseline in the Number of Circulating Tumor Cells (CTCs)
Measured: Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years
Overall Minimum Percentage Change From Previous Time Point in Circulating Tumor Cells (CTC)
Measured: 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
Number of Subjects With Any Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Death, and TEAEs Leading to Discontinuation
An AE was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. A serious adverse event was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs were defined as those AEs that started between first dose of study drug and up to 50 days after last dose.
Measured: 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
Pharmacokinetic Parameter: Clearance of Intravenously Administered EMD 525797 After First Dose (CL) and Clearance in Steady State of EMD52597 After Fifth Dose (CLss)
The apparent total body clearance of drug following intravenous administration (CL); The apparent total body clearance of drug at steady state following intravenous administration (CLss).
Measured: 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
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
The apparent volume of distribution during the terminal phase following intravenous administration (V). The estimate of the apparent volume of distribution at steady state following intravenous administration (Vss).
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2011 (estimated)
- Study startApr 2011
- Primary completionApr 2013
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostate Cancer MetastaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- EMD Serono
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Responsible, Study director, EMD Serono Inc., an affiliate of Merck KGaA, Darmstadt, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01360840
- Sponsor's protocol ID
- EMR 62242-006
- Acronym
- PERSEUS
- Status last verified
- Nov 2015
- First submitted
- 15 Apr 2011
- Last updated
- 14 Dec 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01360840
- Acronym / sponsor ID
- PERSEUS / EMR 62242-006
- Conditions
- Prostate Cancer Metastatic
- Keywords
- Asymptomatic, mildly symptomatic, metastatic castrate-resistant prostate cancer, mCRPC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- EMD SeronoIndustry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 26 May 2011 (estimated)
- Results
- Posted 14 Dec 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo + Standard of care (SoC) | Placebo comparator | Other: Placebo, Other: Standard of Care (SoC) |
| EMD 525797 750 mg + SoC | Experimental | Drug: EMD 525797, Other: Standard of Care (SoC) |
| EMD 525797 1500 mg + SoC | Experimental | Drug: EMD 525797, Other: Standard of Care (SoC) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EMD 525797Subjects 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. | Drug | EMD 525797 1500 mg + SoC |
| EMD 525797Subjects 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. | Drug | EMD 525797 750 mg + SoC |
| PlaceboSubjects 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 | Placebo + Standard of care (SoC) |
| Standard of Care (SoC)All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). | Other | EMD 525797 1500 mg + SoC, EMD 525797 750 mg + SoC, Placebo + Standard of care (SoC) |
Primary outcome
Progression Free Survival (PFS) Time
Time frame: Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years
PFS was defined as time from randomization until the first documented sign of objective radiographic disease progression (ORDP) or death from any cause. Death was considered as an event only if it was reported within 12 weeks after last tumor assessment without progression. ORDP was defined as: Bone lesion progression (2 or more new bone lesions compared to baseline) assessed with bone scintigraphy. Assessment was based on Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST v1.0) modified as per Prostate Cancer Working Group 2 (PCWG-2); Soft-tissue lesion progression assessed with CT scans according to RECIST v1.0 modified as per PCWG-2; Presence of skeletal events defined as cord compression/fracture documented via a scheduled or unscheduled radiographic assessment triggered by increased pain or other signs and/or symptoms, based on the investigator's discretion; Non-radiological events, including emergency bone irradiation and surgery, were not investigated.
14 secondary outcomes
Overall Survival
Time frame: Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years
Time to Tumor Progression
Time frame: Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years
Number of Subjects With Presence of Tumor Response and Disease Control (DC) in Soft Tissue Lesions
Time frame: Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years
Number of Subjects With New Bone Lesions Compared to Baseline
Time frame: Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years
Number of Subjects With Presence of DC in Bone Lesions
Time frame: At Weeks 13, 19 and 25
Bone and Soft Tissue Lesions Composite Tumor Response
Time frame: Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years
Number of Subjects With Presence of Skeletal Related Events
Time frame: Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years
Number of Subjects With Presence of Prostate Specific Antigen (PSA) Response
Time frame: Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years
Minimum Percentage Change From Baseline in PSA Serum Concentration
Time frame: Baseline, up to data cut-off date (30 April 2013), assessed up to 2 years
Minimum Percentage Change From Baseline in the Number of Circulating Tumor Cells (CTCs)
Time frame: Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years
Overall Minimum Percentage Change From Previous Time Point in Circulating Tumor Cells (CTC)
Time frame: 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
Number of Subjects With Any Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Death, and TEAEs Leading to Discontinuation
Time frame: 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
Pharmacokinetic Parameter: Clearance of Intravenously Administered EMD 525797 After First Dose (CL) and Clearance in Steady State of EMD52597 After Fifth Dose (CLss)
Time frame: 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
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
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Responsible study director
EMD Serono Inc., an affiliate of Merck KGaA, Darmstadt, Germany
71 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing EMD 525797 in people with Prostate Cancer Metastatic, run by EMD Serono at 71 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 71 sites in United States, Australia, Germany, Russia, France and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (PFS) Time (time frame: Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2015.