Trial · NCT00617890
A Study to Determine the Activity of Robatumumab (SCH 717454) in Participants With Relapsed Osteosarcoma or Ewing's Sarcoma (MK-7454-002/P04720)
NCT00617890, Phase 2, Terminated, Merck Sharp & Dohme LLC; results first posted 2015-12-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Determine the Activity of Robatumumab (SCH 717454) in Participants With Relapsed Osteosarcoma or Ewing's Sarcoma (MK-7454-002/P04720). Trials, record NCT00617890. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00617890
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Determine the Activity of Robatumumab (SCH 717454) in Participants With Relapsed Osteosarcoma or Ewing's Sarcoma (MK-7454-002/P04720)
- NCT number
- NCT00617890
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 219 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Osteosarcoma, Sarcoma, Ewing's, Peripheral Neuroectodermal Tumor
- Interventions
- robatumumab
- First posted
- 2008-02-18
- Last updated
- 2018-08-23
- Results first posted
- 2015-12-11
- Limitations and caveats
- The study was stopped prematurely for administrative reasons; not all planned endpoints were analyzed.
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Achieving a Complete Response or Partial Response (Group 3 Only) | Up to 1 year following the start of study therapy | This is a measure of the number of participants with a complete response (CR) or partial response (PR) to therapy, confirmed by central review. Response was based on Response Evaluation Criteria in Solid Tumors (RECIST) and World Health Organization (WHO) criteria. |
| Primary | Number of Participants With >= 25% Change in Tumor Proliferation After Exposure to Robatumumab (Group 1 Only) | Approximately 14 days | Tumor proliferation was measured using Ki-67 levels. Ki-67 is nuclear protein associated with cellular proliferation. |
| Primary | Number of Participants Achieving a Complete Response, a Partial Response, or Stable Disease (Group 2 Only) | Up to 1 year following the start of study therapy | Responses to treatment (complete response, partial response, or stable disease) confirmed by central review for Participants in Group 2. Response was based on Response Evaluation Criteria in Solid Tumors (RECIST) and World Health Organization (WHO) criteria. |
| Secondary | Overall Survival | From start of treatment until death or data analysis cut off (Up to 3.4 years) | This is a measure of the number of participants known to be alive at the time of data analysis for this study. |
| Secondary | Time Until Tumor Relapse (Group 1 Only) | From start of treatment until relapse or data analysis cut off (Up to 3.4 years) | This is a measure of the time from the start of the study to documented relapse of disease. |
| Secondary | Area Under the Concentration-time Curve (AUC) of Serum Levels of Robatumumab (Group 1 Only) | End of infusion on Day 1, and then prior to surgery, before and after the 2nd, 3rd, and 8th doses (up to 20 weeks) | |
| Secondary | Incidence of Anti-robatumumab Antibodies | Up to 2 years | For biological agents, it is possible for the host (participant) to develop antibodies to the agent. This outcome measure was planned to find out the number of participants who developed the antibodies after treatment with robatumumab. |
| Secondary | Number of Participants Experiencing Treatment-Emergent Adverse Events | Up to 2 years | An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment. Treatment-emergent adverse events are those that occur after participants have received study treatment, or existing adverse events that occurred during screening that increase in severity after study treatment. Adverse events in the Group 1: 0.3 mg/kg arm that occurred after switching to the 10 mg/kg dose are displayed under the originally assigned treatment. |
| Secondary | Time to Disease Progression (Groups 2 and 3 Only) | From the start of treatment until disease progression or data analysis cut off (Up to 3.4 years) | This is a measure of the time from the start of the study to the time of documented disease progression. |
| Secondary | Overall Survival (Groups 2 and 3 Only) | From start of treatment until death or data analysis cut off (Up to 3.4 years) | This is a measure of the time of survival from first dose to documentation of death |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Achieving a Complete Response or Partial Response (Group 3 Only) | Up to 1 year following the start of study therapy | Participants in Group 3 with evaluable data. | Participants | NUMBER |
| PRIMARY | Number of Participants With >= 25% Change in Tumor Proliferation After Exposure to Robatumumab (Group 1 Only) | Approximately 14 days | Group 1 Participants; this outcome was not evaluated due to early termination of the study. | ||
| PRIMARY | Number of Participants Achieving a Complete Response, a Partial Response, or Stable Disease (Group 2 Only) | Up to 1 year following the start of study therapy | Group 2 participants with evaluable data. | Participants | NUMBER |
| SECONDARY | Overall Survival | From start of treatment until death or data analysis cut off (Up to 3.4 years) | All study participants | Participants | NUMBER |
| SECONDARY | Time Until Tumor Relapse (Group 1 Only) | From start of treatment until relapse or data analysis cut off (Up to 3.4 years) | Group 1 participants; this outcome was not evaluated due to early termination of the study. | ||
| SECONDARY | Area Under the Concentration-time Curve (AUC) of Serum Levels of Robatumumab (Group 1 Only) | End of infusion on Day 1, and then prior to surgery, before and after the 2nd, 3rd, and 8th doses (up to 20 weeks) | Group 1, both dose levels: this outcome was not evaluated due to early termination of the study. | ||
| SECONDARY | Incidence of Anti-robatumumab Antibodies | Up to 2 years | This outcome was not evaluated due to early termination of the study. | ||
| SECONDARY | Number of Participants Experiencing Treatment-Emergent Adverse Events | Up to 2 years | All participants receiving study drug. | Participants | NUMBER |
| SECONDARY | Time to Disease Progression (Groups 2 and 3 Only) | From the start of treatment until disease progression or data analysis cut off (Up to 3.4 years) | All participants in Groups 2 and 3; this outcome was not evaluated due to early termination of the study | ||
| SECONDARY | Overall Survival (Groups 2 and 3 Only) | From start of treatment until death or data analysis cut off (Up to 3.4 years) | Group 2 and 3 Participants | Months | MEDIAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Achieving a Complete Response or Partial Response (Group 3 Only) | Group 3: 10 mg/kg | 6 | Participants | ||
| Number of Participants Achieving a Complete Response, a Partial Response, or Stable Disease (Group 2 Only) | Group 2: 10 mg/kg | 6 | Participants | ||
| Overall Survival | Group 1: 0.3 mg/kg | 17 | Participants | ||
| Overall Survival | Group 1: 10 mg/kg | 16 | Participants | ||
| Overall Survival | Group 2: 10 mg/kg | 7 | Participants | ||
| Overall Survival | Group 3: 10 mg/kg | 28 | Participants | ||
| Number of Participants Experiencing Treatment-Emergent Adverse Events | Group 1: 0.3 mg/kg | 31 | Participants | ||
| Number of Participants Experiencing Treatment-Emergent Adverse Events | Group 1: 10 mg/kg | 30 | Participants | ||
| Number of Participants Experiencing Treatment-Emergent Adverse Events | Group 2: 10 mg/kg | 31 | Participants | ||
| Number of Participants Experiencing Treatment-Emergent Adverse Events | Group 3: 10 mg/kg | 112 | Participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Group 1: 0.3 mg/kg | 35 | |
| Overall Study | STARTED | Group 1: 10 mg/kg | 33 | |
| Overall Study | STARTED | Group 2: 10 mg/kg | 35 | |
| Overall Study | STARTED | Group 3: 10 mg/kg | 116 | |
| Overall Study | Received Treatment | Group 1: 0.3 mg/kg | 34 | |
| Overall Study | Received Treatment | Group 1: 10 mg/kg | 33 | |
| Overall Study | Received Treatment | Group 2: 10 mg/kg | 34 | |
| Overall Study | Received Treatment | Group 3: 10 mg/kg | 115 | |
| Overall Study | COMPLETED | Group 1: 0.3 mg/kg | 4 | |
| Overall Study | COMPLETED | Group 1: 10 mg/kg | 5 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events796
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 | Group 1: 0.3mg/kg | 6 | 34 | 8 |
| other | ANAEMIA | Blood and lymphatic system disorders | Group 1: 10mg/kg | 2 | 33 | 3 |
| other | ANAEMIA | Blood and lymphatic system disorders | Group 2: 10mg/kg | 3 | 34 | 4 |
| other | ANAEMIA | Blood and lymphatic system disorders | Group 3: 10mg/kg | 22 | 115 | 44 |
| other | LEUKOPENIA | Blood and lymphatic system disorders | Group 1: 0.3mg/kg | 1 | 34 | 1 |
| other | LEUKOPENIA | Blood and lymphatic system disorders | Group 1: 10mg/kg | 2 | 33 | 2 |
| other | LEUKOPENIA | Blood and lymphatic system disorders | Group 2: 10mg/kg | 0 | 34 | 0 |
| other | LEUKOPENIA | Blood and lymphatic system disorders | Group 3: 10mg/kg | 3 | 115 | 4 |
| other | NEUTROPENIA | Blood and lymphatic system disorders | Group 1: 0.3mg/kg | 0 | 34 | 0 |
| other | NEUTROPENIA | Blood and lymphatic system disorders | Group 1: 10mg/kg | 1 | 33 | 1 |
1 to 10 of 796Source ClinicalTrials.gov
See all 796 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group 1: 0.3mg/kg | ||
| Total, all-cause mortality | Group 1: 10mg/kg | ||
| Total, all-cause mortality | Group 2: 10mg/kg | ||
| Total, all-cause mortality | Group 3: 10mg/kg | ||
| Total, other adverse events | Group 1: 0.3mg/kg | 28 | 34 |
| Total, other adverse events | Group 1: 10mg/kg | 30 | 33 |
| Total, other adverse events | Group 2: 10mg/kg | 29 | 34 |
| Total, other adverse events | Group 3: 10mg/kg | 104 | 115 |
| Total, serious adverse events | Group 1: 0.3mg/kg | 17 | 34 |
| Total, serious adverse events | Group 1: 10mg/kg | 8 | 33 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
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/NCT00617890
GET https://conductscience.org/api/trials/v1/NCT00617890/events?page=2