Trial · NCT00965250
Multicenter Phase II Study of IMC-A12 in Patients With Thymoma and Thymic Carcinoma Who Have Been Previously Treated With Chemotherapy
NCT00965250, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2012-11-14
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Multicenter Phase II Study of IMC-A12 in Patients With Thymoma and Thymic Carcinoma Who Have Been Previously Treated With Chemotherapy. Trials, record NCT00965250. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00965250
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Multicenter Phase II Study of IMC-A12 in Patients With Thymoma and Thymic Carcinoma Who Have Been Previously Treated With Chemotherapy
- NCT number
- NCT00965250
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 49 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Thymoma, Thymic Carcinoma, Thymic Carcinoid, Thymic Neuroendocrine Tumors
- Interventions
- IMC-12
- First posted
- 2009-08-25
- Last updated
- 2016-12-23
- Results first posted
- 2012-11-14
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (Partial Response (PR)+Complete Response (CR)) to IMC-A12 Monotherapy in Patients With Advanced or Recurrent Thymoma or Thymic Carcinoma. | Patients were assessed for response every 2 cycles (every 6 weeks) while receiving the study drug. | Objective response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Complete response (CR) is the disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive disease (PD) is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started. |
| Secondary | Number of Participants With Adverse Events | 81 months and 17 days | Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module. |
| Secondary | Percentage of Participants Who Respond to Treatment | 39 months | Percentage of participants who respond to treatment was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). |
| Secondary | Disease Control Rate (DCR) | 39 months | Disease control rate is defined as objective response plus stable disease. |
| Secondary | Time to Progression | 39 months | Time between the first day of treatment to the day of disease progression. |
| Secondary | Overall Survival | 39 months | Time from treatment start date until date of death or date last known alive. |
| Secondary | Median Number of Cycles of Therapy | 6 weeks | A cycle is defined as 21 days or 6 weeks of therapy. |
| Secondary | Correlate Response to Therapy With Changes in FDG-PET Imaging | 6 weeks after initiation of treatment | Participants with scans that showed neither sufficient shrinkage to qualify as an objective response nor sufficient increase to qualify as disease progression, taking as reference the smallest cumulative longest dimension since start of treatment, to have stable disease. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Response Rate (Partial Response (PR)+Complete Response (CR)) to IMC-A12 Monotherapy in Patients With Advanced or Recurrent Thymoma or Thymic Carcinoma. | Patients were assessed for response every 2 cycles (every 6 weeks) while receiving the study drug. | Participants | NUMBER | |
| SECONDARY | Number of Participants With Adverse Events | 81 months and 17 days | Adverse events are not separated by group because the adverse events are related to the drug which was the same in both groups. | Participants | NUMBER |
| SECONDARY | Percentage of Participants Who Respond to Treatment | 39 months | percentage of participants | NUMBER | |
| SECONDARY | Disease Control Rate (DCR) | 39 months | percentage of participants | NUMBER | |
| SECONDARY | Time to Progression | 39 months | Months | MEDIAN | |
| SECONDARY | Overall Survival | 39 months | Months | MEDIAN | |
| SECONDARY | Median Number of Cycles of Therapy | 6 weeks | Cycles | MEDIAN | |
| SECONDARY | Correlate Response to Therapy With Changes in FDG-PET Imaging | 6 weeks after initiation of treatment | We did radiological assessment ourselves, and an independent radiological assessment was not undertaken for assessment of response or progression. |
Source ClinicalTrials.gov
Results by group19
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response Rate (Partial Response (PR)+Complete Response (CR)) to IMC-A12 Monotherapy in Patients With Advanced or Recurrent Thymoma or Thymic Carcinoma. | Thymoma | Complete Response | 0 | Participants | |
| Objective Response Rate (Partial Response (PR)+Complete Response (CR)) to IMC-A12 Monotherapy in Patients With Advanced or Recurrent Thymoma or Thymic Carcinoma. | Thymic Carcinoma | Complete Response | 0 | Participants | |
| Objective Response Rate (Partial Response (PR)+Complete Response (CR)) to IMC-A12 Monotherapy in Patients With Advanced or Recurrent Thymoma or Thymic Carcinoma. | Thymoma | Partial Response | 5 | Participants | |
| Objective Response Rate (Partial Response (PR)+Complete Response (CR)) to IMC-A12 Monotherapy in Patients With Advanced or Recurrent Thymoma or Thymic Carcinoma. | Thymic Carcinoma | Partial Response | 0 | Participants | |
| Objective Response Rate (Partial Response (PR)+Complete Response (CR)) to IMC-A12 Monotherapy in Patients With Advanced or Recurrent Thymoma or Thymic Carcinoma. | Thymoma | Stable Disease | 28 | Participants | |
| Objective Response Rate (Partial Response (PR)+Complete Response (CR)) to IMC-A12 Monotherapy in Patients With Advanced or Recurrent Thymoma or Thymic Carcinoma. | Thymic Carcinoma | Stable Disease | 5 | Participants | |
| Objective Response Rate (Partial Response (PR)+Complete Response (CR)) to IMC-A12 Monotherapy in Patients With Advanced or Recurrent Thymoma or Thymic Carcinoma. | Thymoma | Progressive Disease | 4 | Participants | |
| Objective Response Rate (Partial Response (PR)+Complete Response (CR)) to IMC-A12 Monotherapy in Patients With Advanced or Recurrent Thymoma or Thymic Carcinoma. | Thymic Carcinoma | Progressive Disease | 7 | Participants | |
| Number of Participants With Adverse Events | IMC-A12 Monotherapy in Patients | 49 | Participants | ||
| Percentage of Participants Who Respond to Treatment | Thymoma | 14 | 95% Confidence Interval 5 to 29 | percentage of participants |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Thymoma | 37 | |
| Overall Study | STARTED | Thymic Carcinoma | 12 | |
| Overall Study | COMPLETED | Thymoma | 37 | |
| Overall Study | COMPLETED | Thymic Carcinoma | 12 | |
| Overall Study | NOT COMPLETED | Thymoma | 0 | |
| Overall Study | NOT COMPLETED | Thymic Carcinoma | 0 |
Source ClinicalTrials.gov
Adverse events155
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 | Abdominal distention | Gastrointestinal disorders | IMC-A12 Monotherapy in Patients | 1 | 49 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | IMC-A12 Monotherapy in Patients | 3 | 49 | 3 |
| other | Activated partial thromboplastin time prolonged | Blood and lymphatic system disorders | IMC-A12 Monotherapy in Patients | 7 | 49 | 12 |
| other | Acute coronary syndrome | Cardiac disorders | IMC-A12 Monotherapy in Patients | 2 | 49 | 2 |
| other | Alanine aminotransferase increased | Metabolism and nutrition disorders | IMC-A12 Monotherapy in Patients | 23 | 49 | 60 |
| other | Alkaline phosphatase increased | Metabolism and nutrition disorders | IMC-A12 Monotherapy in Patients | 17 | 49 | 31 |
| other | Allergic reaction | Immune system disorders | IMC-A12 Monotherapy in Patients | 2 | 49 | 2 |
| other | Allergic rhinitis | Immune system disorders | IMC-A12 Monotherapy in Patients | 7 | 49 | 7 |
| other | Alopecia | Skin and subcutaneous tissue disorders | IMC-A12 Monotherapy in Patients | 7 | 49 | 7 |
| other | Anemia | Blood and lymphatic system disorders | IMC-A12 Monotherapy in Patients | 35 | 49 | 105 |
1 to 10 of 155Source ClinicalTrials.gov
See all 155 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | IMC-A12 Monotherapy in Patients | ||
| Total, other adverse events | IMC-A12 Monotherapy in Patients | 49 | 49 |
| Total, serious adverse events | IMC-A12 Monotherapy in Patients | 29 | 49 |
Source ClinicalTrials.gov
Papers4
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/NCT00965250
GET https://conductscience.org/api/trials/v1/NCT00965250/events?page=2