Trial · NCT00617890
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| 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 |
| Secondary | Duration of Response (Groups 2 and 3 Only) | From time of documented response until disease progression or data analysis cut off (Up to 3.4 years) | This is a measure of the amount of time in which the tumor responded to therapy. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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
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GET https://conductscience.org/api/trials/v1/NCT00617890/registered