Trial · NCT00668148
A Five-Tier, Open-Label Study of IMC-A12 in Advanced Sarcoma
NCT00668148, Phase 2, Completed, Eli Lilly and Company; results first posted 2018-07-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Five-Tier, Open-Label Study of IMC-A12 in Advanced Sarcoma. Trials, record NCT00668148. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00668148
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Five-Tier, Open-Label Study of IMC-A12 in Advanced Sarcoma
- NCT number
- NCT00668148
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 113 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Ewing's Sarcoma /Peripheral Neuroectodermal Tumor (PNET), Rhabdomyosarcoma, Leiomyosarcoma, Adipocytic Sarcoma, Synovial Sarcoma
- Interventions
- IMC-A12 (cixutumumab), IMC-A12 (cixutumumab), IMC-A12 (cixutumumab), IMC-A12 (cixutumumab), IMC-A12 (cixutumumab)
- First posted
- 2008-04-29
- Last updated
- 2018-07-17
- Other registries' IDs
- eudract:2007-006719-21
- Results first posted
- 2018-07-17
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Progression-Free Survival (PFS) at 12 Weeks | Baseline to Disease Progression or Death Due to Any Cause Up To 12 Weeks | PFS at 12 weeks was reported by disease condition and defined as the percentage of participants who have neither experienced disease progression nor died at 12 weeks after the date of first dose. Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.0) criteria. Progressive Disease (PD) was defined as having at least a 20% increase in sum of the longest diameter of target lesions or the appearance of new lesions. Percentage of participants is calculated as the total number of participants with PFS at 12 weeks divided by the total number of participants treated then multiplied by 100. |
| Secondary | Progression-Free Survival (PFS) | Baseline to measured PD (up to 105.4 weeks) | PFS was reported by disease condition and defined as the interval from the date of first dose until disease progression or death whichever occurred earlier. Response was defined using RECIST, version 1.0 criteria. PD was defined as having at least a 20% increase in sum of the longest diameter of target lesions or the appearance of new lesions. PFS was censored at the date of the last objective progression-free disease assessment for participants who did not experience disease progression or death. |
| Secondary | Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)] | Baseline to measured PD (up to 105.4 weeks) | ORR was reported by disease condition and defined as the percentage of participants achieving either CR or PR. Response was defined using RECIST, version 1.0 criteria. CR was defined as the disappearance of all target lesions. PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions. Percentage of participants is calculated as a total number of participants with CR or PR divided by the total number of participants treated then multiplied by 100. |
| Secondary | Time to Response | Baseline to first evidence of confirmed CR or PR (up to 105.4 weeks) | |
| Secondary | Duration of Response | Date of first response to the date of progression or death due to any cause (up to 105.4 weeks) | |
| Secondary | Overall Survival (OS) | Baseline to date of death from any cause (up to 112.9 weeks) | OS was reported by disease condition and defined as the duration from the date of enrollment to the date of death from any cause. For participants who were alive, OS was censored at the date of last follow-up visit or at the date of last contact. |
| Secondary | Percentage of Participants With Best Overall Response [Clinical Benefit Rate (CBR)] | Baseline through study completion (up to 105.4 weeks) | CBR was reported by disease condition. Response was defined using RECIST, version 1.0 criteria. CR was defined as the disappearance of all target lesions. PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions. Stable Disease (SD) was defined as small changes that did not meet the above criteria. Percentage of participants with best overall response is calculated as a total number of participants with CR or PR or SD divided by the total number of participants treated then multiplied by 100. |
| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Deaths | Baseline through study completion (up to 112.9 weeks) | TEAEs were defined as serious and other non-serious AEs that occurred or worsened after study treatment (regardless of causality). Data presented are the number of participants who experienced TEAEs, serious TEAEs, and deaths during the study including the 30-day follow-up. A summary of serious and other non-serious AEs regardless of causality is located in the Reported Adverse Event module. |
| Secondary | Serum Anti-IMC-A12 Antibody Assessment (Immunogenicity) | 30-day safety follow-up |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Progression-Free Survival (PFS) at 12 Weeks | Baseline to Disease Progression or Death Due to Any Cause Up To 12 Weeks | Enrolled participants who received any quantity of IMC-A12. | percentage of participants | NUMBER |
| SECONDARY | Progression-Free Survival (PFS) | Baseline to measured PD (up to 105.4 weeks) | Enrolled participants who received any quantity of IMC-A12. Three (3) participants in Ewing's sarcoma/PNET, 1 participant in rhabdomyosarcoma, 4 participants in leiomyosarcoma, 6 participants in adipocytic sarcoma, and 3 participants in synovial sarcoma groups were censored for analysis. | weeks | MEDIAN |
| SECONDARY | Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)] | Baseline to measured PD (up to 105.4 weeks) | Enrolled participants who received any quantity of IMC-A12. | percentage of participants | NUMBER |
| SECONDARY | Time to Response | Baseline to first evidence of confirmed CR or PR (up to 105.4 weeks) | Zero participants analyzed. Time to Response for CR and PR data was not collected for analysis per study report. | ||
| SECONDARY | Duration of Response | Date of first response to the date of progression or death due to any cause (up to 105.4 weeks) | Zero participants analyzed. Duration to Response for CR and PR data was not collected for analysis per study report. | ||
| SECONDARY | Overall Survival (OS) | Baseline to date of death from any cause (up to 112.9 weeks) | Enrolled participants who received any quantity of IMC-A12. Five (5) participants in Ewing's sarcoma/PNET, 4 participants in rhabdomyosarcoma, 12 participants in leiomyosarcoma, 11 participants in adipocytic sarcoma, and 5 participants in synovial sarcoma groups were censored for analysis. | weeks | MEDIAN |
| SECONDARY | Percentage of Participants With Best Overall Response [Clinical Benefit Rate (CBR)] | Baseline through study completion (up to 105.4 weeks) | Enrolled participants who received any quantity of IMC-A12. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Deaths | Baseline through study completion (up to 112.9 weeks) | Enrolled participants who received any quantity of IMC-A12. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Serum Anti-IMC-A12 Antibody Assessment (Immunogenicity) | 30-day safety follow-up | Zero participants analyzed. Analysis was not performed due to lack of available assay. |
Source ClinicalTrials.gov
Results by group35
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Progression-Free Survival (PFS) at 12 Weeks | Ewing's Sarcoma/PNET | 27.3 | 95% Confidence Interval 8.5 to 50.4 | percentage of participants | |
| Percentage of Participants With Progression-Free Survival (PFS) at 12 Weeks | Rhabdomyosarcoma | 12.5 | 95% Confidence Interval 2.1 to 32.8 | percentage of participants | |
| Percentage of Participants With Progression-Free Survival (PFS) at 12 Weeks | Leiomyosarcoma | 25.4 | 95% Confidence Interval 8.4 to 46.8 | percentage of participants | |
| Percentage of Participants With Progression-Free Survival (PFS) at 12 Weeks | Adipocytic Sarcoma | 50.0 | 95% Confidence Interval 32.9 to 64.9 | percentage of participants | |
| Percentage of Participants With Progression-Free Survival (PFS) at 12 Weeks | Synovial Sarcoma | 21.4 | 95% Confidence Interval 5.2 to 44.8 | percentage of participants | |
| Percentage of Participants With Progression-Free Survival (PFS) at 12 Weeks | Total | 31.9 | 95% Confidence Interval 23.0 to 41.1 | percentage of participants | |
| Progression-Free Survival (PFS) | Ewing's Sarcoma/PNET | 6.4 | 95% Confidence Interval 5.1 to 12.1 | weeks | |
| Progression-Free Survival (PFS) | Rhabdomyosarcoma | 6.1 | 95% Confidence Interval 5.1 to 7.3 | weeks | |
| Progression-Free Survival (PFS) | Leiomyosarcoma | 6.0 | 95% Confidence Interval 5.4 to 11.0 | weeks | |
| Progression-Free Survival (PFS) | Adipocytic Sarcoma | 12.1 | 95% Confidence Interval 6.0 to 17.7 | weeks |
1 to 10 of 35Source ClinicalTrials.gov
See all 35 results by groupParticipant flow4
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Entire Study Population | 113 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Entire Study Population | 111 | |
| Overall Study | COMPLETED | Entire Study Population | 103 | |
| Overall Study | NOT COMPLETED | Entire Study Population | 10 |
Source ClinicalTrials.gov
Adverse events86
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 | Entire Study Population | 13 | 111 | 29 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Entire Study Population | 6 | 111 | 10 |
| other | Abdominal pain | Gastrointestinal disorders | Entire Study Population | 10 | 111 | 24 |
| other | Constipation | Gastrointestinal disorders | Entire Study Population | 16 | 111 | 18 |
| other | Diarrhoea | Gastrointestinal disorders | Entire Study Population | 25 | 111 | 42 |
| other | Nausea | Gastrointestinal disorders | Entire Study Population | 28 | 111 | 32 |
| other | Vomiting | Gastrointestinal disorders | Entire Study Population | 15 | 111 | 18 |
| other | Asthenia | General disorders | Entire Study Population | 17 | 111 | 81 |
| other | Chest pain | General disorders | Entire Study Population | 6 | 111 | 6 |
| other | Fatigue | General disorders | Entire Study Population | 26 | 111 | 36 |
1 to 10 of 86Source ClinicalTrials.gov
See all 86 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Entire Study Population | ||
| Total, other adverse events | Entire Study Population | 97 | 111 |
| Total, serious adverse events | Entire Study Population | 56 | 111 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 22682017 | DERIVED |
Source PubMed
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/NCT00668148
GET https://conductscience.org/api/trials/v1/NCT00668148/results?page=2