EMD 525797 in Subjects With Asymptomatic or Mildly Symptomatic Metastatic Castrate-resistant Prostate Cancer (PERSEUS)
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| ClinicalTrials.gov Identifier: NCT01360840 |
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Recruitment Status :
Completed
First Posted : May 26, 2011
Results First Posted : December 14, 2015
Last Update Posted : December 14, 2015
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Sponsor:
EMD Serono
Information provided by (Responsible Party):
EMD Serono
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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).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Prostate Cancer Metastatic | Drug: EMD 525797 Other: Placebo Other: Standard of Care (SoC) | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 180 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| 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 Start Date : | April 2011 |
| Actual Primary Completion Date : | April 2013 |
| Actual Study Completion Date : | July 2014 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Prostate cancer
MedlinePlus related topics:
Prostate Cancer
| Arm | Intervention/treatment |
|---|---|
| Placebo Comparator: Placebo + Standard of care (SoC) |
Other: 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: Standard of Care (SoC) All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). |
| Experimental: EMD 525797 750 mg + SoC |
Drug: 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: Standard of Care (SoC) All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). |
| Experimental: EMD 525797 1500 mg + SoC |
Drug: 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. Other: Standard of Care (SoC) All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). |
Primary Outcome Measures :
- 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.
Secondary Outcome Measures :
- Overall Survival [ Time Frame: Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years ]Overall Survival was defined as the time from the date of randomization to the date of death from any cause.
- Time to Tumor Progression [ Time Frame: Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years ]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.
- 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 ]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.
- 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 ]New bone lesions were evaluated by bone scintigraphy for subjects with bone lesions at baseline.
- Number of Subjects With Presence of DC in Bone Lesions [ Time Frame: At Weeks 13, 19 and 25 ]Presence of DC in bone lesions was defined as the appearance of less than 2 new bone lesions, documented by bone scintigraphy.
- 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 ]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.
- 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 ]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.
- 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 ]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.
- 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 ]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.
- 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 ]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).
- 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 ]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).
Other Outcome Measures:
- To Explore the Relationship Between Number and/or Changes of Numbers of Biomarker and the Clinical Outcome [ Time Frame: From the date of randomization up to data cut-off date (30 April 2013), assessed up to 2 years ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01360840
Locations
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Sponsors and Collaborators
EMD Serono
Investigators
| Study Director: | Medical Responsible | EMD Serono Inc., an affiliate of Merck KGaA, Darmstadt, Germany |
| Responsible Party: | EMD Serono |
| ClinicalTrials.gov Identifier: | NCT01360840 |
| Other Study ID Numbers: |
EMR 62242-006 |
| First Posted: | May 26, 2011 Key Record Dates |
| Results First Posted: | December 14, 2015 |
| Last Update Posted: | December 14, 2015 |
| Last Verified: | November 2015 |
Keywords provided by EMD Serono:
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Asymptomatic mildly symptomatic metastatic castrate-resistant prostate cancer mCRPC |
Additional relevant MeSH terms:
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Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms |
Genital Diseases, Male Genital Diseases Urogenital Diseases Prostatic Diseases Male Urogenital Diseases |