Trial · NCT01360840
EMD 525797 in Subjects With Asymptomatic or Mildly Symptomatic Metastatic Castrate-resistant Prostate Cancer
NCT01360840, Phase 2, Completed, EMD Serono; results first posted 2015-12-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. EMD 525797 in Subjects With Asymptomatic or Mildly Symptomatic Metastatic Castrate-resistant Prostate Cancer. Trials, record NCT01360840. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01360840
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- EMD 525797 in Subjects With Asymptomatic or Mildly Symptomatic Metastatic Castrate-resistant Prostate Cancer
- NCT number
- NCT01360840
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 180 participants, actual
- Lead sponsor
- EMD Serono
- Conditions
- Prostate Cancer Metastatic
- Interventions
- EMD 525797, EMD 525797, Placebo, Standard of Care (SoC)
- First posted
- 2011-05-26
- Last updated
- 2015-12-14
- Results first posted
- 2015-12-14
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival (PFS) Time | 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 | Overall Survival | 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. |
| Secondary | Time to Tumor Progression | 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. |
| Secondary | Number of Subjects With Presence of Tumor Response and Disease Control (DC) in Soft Tissue Lesions | 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. |
| Secondary | Number of Subjects With New Bone Lesions Compared to Baseline | 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. |
| Secondary | Number of Subjects With Presence of DC in Bone Lesions | 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. |
| Secondary | Bone and Soft Tissue Lesions Composite Tumor Response | 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. |
| Secondary | Number of Subjects With Presence of Skeletal Related Events | 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. |
| Secondary | Number of Subjects With Presence of Prostate Specific Antigen (PSA) Response | 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. |
| Secondary | Minimum Percentage Change From Baseline in PSA Serum Concentration | Baseline, up to data cut-off date (30 April 2013), assessed up to 2 years |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression Free Survival (PFS) Time | Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years | Intention-to-treat (ITT) analysis set included all the subjects who were randomized in the study. | months | MEDIAN |
| SECONDARY | Overall Survival | Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years | ITT analysis set included all the subjects who were randomized in the study. | months | MEDIAN |
| SECONDARY | Time to Tumor Progression | Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years | ITT analysis set included all the subjects who were randomized in the study. | months | MEDIAN |
| SECONDARY | Number of Subjects With Presence of Tumor Response and Disease Control (DC) in Soft Tissue Lesions | Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years | ITT analysis set included all the subjects who were randomized in the study. N signifies the total number of subjects evaluable for this outcome measure. | Subjects | NUMBER |
| SECONDARY | Number of Subjects With New Bone Lesions Compared to Baseline | Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years | ITT analysis set included all the subjects randomized in the study. N signifies the total number of subjects evaluable for this outcome measure. | Subjects | NUMBER |
| SECONDARY | Number of Subjects With Presence of DC in Bone Lesions | At Weeks 13, 19 and 25 | ITT analysis set included all the subjects randomized in the study. | Subjects | NUMBER |
| SECONDARY | Bone and Soft Tissue Lesions Composite Tumor Response | Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years | ITT analysis set included all the subjects who were randomized in the study. | Subjects | NUMBER |
| SECONDARY | Number of Subjects With Presence of Skeletal Related Events | Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years | ITT analysis set included all the subjects who were randomized in the study. | Subjects | NUMBER |
| SECONDARY | Number of Subjects With Presence of Prostate Specific Antigen (PSA) Response | Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years | ITT analysis set included all the subjects who were randomized in the study. N signifies the total number of subjects evaluable for this outcome measure. | Subjects | NUMBER |
| SECONDARY | Minimum Percentage Change From Baseline in PSA Serum Concentration | Baseline, up to data cut-off date (30 April 2013), assessed up to 2 years | ITT analysis set included all the subjects who were randomized in the study. N signifies the total number of subjects evaluable for this outcome measure. | Percent change | MEAN |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group65
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression Free Survival (PFS) Time | Placebo + SoC | 3.3 | 95% Confidence Interval 2.8 to 4.8 | months | |
| Progression Free Survival (PFS) Time | EMD 525797 750 mg + SoC | 3.4 | 95% Confidence Interval 2.8 to 5.6 | months | |
| Progression Free Survival (PFS) Time | EMD 525797 1500 mg + SoC | 4.3 | 95% Confidence Interval 2.8 to 6.6 | months | |
| Overall Survival | Placebo + SoC | NA | 95% Confidence Interval 14.8 to NA | months | |
| Overall Survival | EMD 525797 750 mg + SoC | NA | 95% Confidence Interval 12.9 to NA | months | |
| Overall Survival | EMD 525797 1500 mg + SoC | NA | 95% Confidence Interval 14.4 to NA | months | |
| Time to Tumor Progression | Placebo + SoC | 3.3 | 95% Confidence Interval 2.8 to 5.4 | months | |
| Time to Tumor Progression | EMD 525797 750 mg + SoC | 3.4 | 95% Confidence Interval 2.8 to 5.6 | months | |
| Time to Tumor Progression | EMD 525797 1500 mg + SoC | 4.6 | 95% Confidence Interval 2.8 to 6.9 | months | |
| Number of Subjects With Presence of Tumor Response and Disease Control (DC) in Soft Tissue Lesions | Placebo + SoC | Tumor response | 1 | Subjects |
1 to 10 of 65Source ClinicalTrials.gov
See all 65 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo + SoC | 60 | |
| Overall Study | STARTED | EMD 525797 750 mg + SoC | 60 | |
| Overall Study | STARTED | EMD 525797 1500 mg + SoC | 60 | |
| Overall Study | COMPLETED | Placebo + SoC | 50 | |
| Overall Study | COMPLETED | EMD 525797 750 mg + SoC | 50 | |
| Overall Study | COMPLETED | EMD 525797 1500 mg + SoC | 51 | |
| Overall Study | NOT COMPLETED | Placebo + SoC | 10 | |
| Overall Study | NOT COMPLETED | EMD 525797 750 mg + SoC | 10 | |
| Overall Study | NOT COMPLETED | EMD 525797 1500 mg + SoC | 9 |
Source ClinicalTrials.gov
Adverse events1,005
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Placebo + SoC | 10 | 60 | |
| other | Anaemia | Blood and lymphatic system disorders | EMD 525797 750 mg + SoC | 6 | 58 | |
| other | Anaemia | Blood and lymphatic system disorders | EMD 525797 1500 mg + SoC | 13 | 60 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Placebo + SoC | 0 | 60 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | EMD 525797 750 mg + SoC | 3 | 58 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | EMD 525797 1500 mg + SoC | 0 | 60 | |
| other | Anaemia macrocytic | Blood and lymphatic system disorders | Placebo + SoC | 0 | 60 | |
| other | Anaemia macrocytic | Blood and lymphatic system disorders | EMD 525797 750 mg + SoC | 0 | 58 | |
| other | Anaemia macrocytic | Blood and lymphatic system disorders | EMD 525797 1500 mg + SoC | 1 | 60 | |
| other | Anaemia of chronic disease | Blood and lymphatic system disorders | Placebo + SoC | 0 | 60 |
1 to 10 of 1,005Source ClinicalTrials.gov
See all 1,005 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo + SoC | ||
| Total, all-cause mortality | EMD 525797 750 mg + SoC | ||
| Total, all-cause mortality | EMD 525797 1500 mg + SoC | ||
| Total, other adverse events | Placebo + SoC | 53 | 60 |
| Total, other adverse events | EMD 525797 750 mg + SoC | 47 | 58 |
| Total, other adverse events | EMD 525797 1500 mg + SoC | 53 | 60 |
| Total, serious adverse events | Placebo + SoC | 16 | 60 |
| Total, serious adverse events | EMD 525797 750 mg + SoC | 13 | 58 |
| Total, serious adverse events | EMD 525797 1500 mg + SoC | 14 | 60 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01360840
GET https://conductscience.org/api/trials/v1/NCT01360840/results?page=2