Trial · NCT00718809
Saracatinib in Treating Patients With Relapsed or Refractory Thymoma or Thymic Cancer
NCT00718809, Phase 2, Terminated, National Cancer Institute (NCI); results first posted 2015-06-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Saracatinib in Treating Patients With Relapsed or Refractory Thymoma or Thymic Cancer. Trials, record NCT00718809. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00718809
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Saracatinib in Treating Patients With Relapsed or Refractory Thymoma or Thymic Cancer
- NCT number
- NCT00718809
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 21 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Invasive Thymoma and Thymic Carcinoma, Recurrent Thymoma and Thymic Carcinoma, Stage III Thymoma, Stage IVA Thymoma, Stage IVB Thymoma
- Interventions
- saracatinib
- First posted
- 2008-07-21
- Last updated
- 2015-06-10
- Results first posted
- 2015-06-10
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (Complete and Partial Response) | Up to 5 years | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. The objective response rate will be reported by each disease classification. The percent of patients having an objective response (complete or partial response) will be estimated with a 95% exact binomial confidence interval for the percent of patients receiving drug. Note: there were no objective responses in this trial. |
| Secondary | Progression-free Survival | Time from the date of registration to the first reported outcome event, assessed up to 5 years | Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. This will be examined in an exploratory fashion using Kaplan-Meier estimates. Time until progression, death or last evaluation will be calculated. If a patient did not progress or die, they will be censored at their last evaluation in the analysis. |
| Secondary | Overall Survival | Time from the date of registration to last reported date of survival, assessed up to 5 years | Will be examined in an exploratory fashion using Kaplan-Meier estimates. Time until death or last evaluation will be calculated. If a patient did not die, they will be censored in the analysis. |
| Secondary | Disease Control Rate | Up to 5 years | Will be examined in an exploratory fashion using Kaplan-Meier estimates. Disease control rate defined as complete response (CR) + partial response (PR) + stable disease (SD). The length of time until progression or until last evaluation will be calculated. For patients who did not progress, they will be censored in the analysis. |
| Secondary | Expected Toxicities Including Skin Rashes and Diarrhea | Up to 5 years | Number of patients who had toxicities classified as skin rashes and diarrhea within the adverse events. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Response Rate (Complete and Partial Response) | Up to 5 years | All patients with at least one post baseline measurement. | percentage of participants | NUMBER |
| SECONDARY | Progression-free Survival | Time from the date of registration to the first reported outcome event, assessed up to 5 years | All patients who enrolled and received treatment. | months | MEDIAN |
| SECONDARY | Overall Survival | Time from the date of registration to last reported date of survival, assessed up to 5 years | All patients who enrolled and received treatment | months | MEDIAN |
| SECONDARY | Disease Control Rate | Up to 5 years | All patients who enrolled and received treatment | months | MEDIAN |
| SECONDARY | Expected Toxicities Including Skin Rashes and Diarrhea | Up to 5 years | All patients | participants | NUMBER |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response Rate (Complete and Partial Response) | Thymoma | 0 | 95% Confidence Interval 0 to 0 | percentage of participants | |
| Objective Response Rate (Complete and Partial Response) | Thymic Carcinoma | 0 | 95% Confidence Interval 0 to 0 | percentage of participants | |
| Progression-free Survival | Thymoma | 5.30 | 95% Confidence Interval 1.74 to 7.80 | months | |
| Progression-free Survival | Thymic Carcinoma | 0.89 | 95% Confidence Interval 0.86 to 3.95 | months | |
| Overall Survival | Thymoma | 37.47 | 95% Confidence Interval 12.27 to NA | months | |
| Overall Survival | Thymic Carcinoma | 6.68 | 95% Confidence Interval 2.47 to 14.97 | months | |
| Disease Control Rate | Thymoma | 5.72 | 95% Confidence Interval 1.84 to 7.80 | months | |
| Disease Control Rate | Thymic Carcinoma | 3.55 | 95% Confidence Interval NA to NA | months | |
| Expected Toxicities Including Skin Rashes and Diarrhea | Thymoma | 10 | participants | ||
| Expected Toxicities Including Skin Rashes and Diarrhea | Thymic Carcinoma | 3 | participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Thymoma | 12 | |
| Overall Study | STARTED | Thymic Carcinoma | 9 | |
| Overall Study | COMPLETED | Thymoma | 0 | |
| Overall Study | COMPLETED | Thymic Carcinoma | 0 | |
| Overall Study | NOT COMPLETED | Thymoma | 12 | |
| Overall Study | NOT COMPLETED | Thymic Carcinoma | 9 |
Source ClinicalTrials.gov
Adverse events222
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 | BLOOD/BONE MARROW | Blood and lymphatic system disorders | Thymoma | 1 | 12 | 1 |
| other | BLOOD/BONE MARROW | Blood and lymphatic system disorders | Thymic Carcinoma | 0 | 9 | 0 |
| other | HEMOLYSIS (E.G., IMMUNE HEMOLYTIC ANEMIA, DRUG-RELATED HEMOLYSIS) | Blood and lymphatic system disorders | Thymoma | 1 | 12 | 1 |
| other | HEMOLYSIS (E.G., IMMUNE HEMOLYTIC ANEMIA, DRUG-RELATED HEMOLYSIS) | Blood and lymphatic system disorders | Thymic Carcinoma | 1 | 9 | 1 |
| other | LEUKOCYTES (TOTAL WBC) | Blood and lymphatic system disorders | Thymoma | 1 | 12 | 1 |
| other | LEUKOCYTES (TOTAL WBC) | Blood and lymphatic system disorders | Thymic Carcinoma | 1 | 9 | 1 |
| other | LYMPHOPENIA | Blood and lymphatic system disorders | Thymoma | 3 | 12 | 3 |
| other | LYMPHOPENIA | Blood and lymphatic system disorders | Thymic Carcinoma | 1 | 9 | 1 |
| other | MYOCARDITIS | Cardiac disorders | Thymoma | 1 | 12 | 1 |
| other | MYOCARDITIS | Cardiac disorders | Thymic Carcinoma | 0 | 9 | 0 |
1 to 10 of 222Source ClinicalTrials.gov
See all 222 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Thymoma | ||
| Total, all-cause mortality | Thymic Carcinoma | ||
| Total, other adverse events | Thymoma | 12 | 12 |
| Total, other adverse events | Thymic Carcinoma | 9 | 9 |
| Total, serious adverse events | Thymoma | 2 | 12 |
| Total, serious adverse events | Thymic Carcinoma | 1 | 9 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 26009269 | 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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Thymoma vs Thymic Carcinoma: Expected Toxicities Including Skin Rashes and Diarrhea | Trial comparisons |
| Thymoma vs Thymic Carcinoma: serious adverse events | Trial comparisons |
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/NCT00718809
GET https://conductscience.org/api/trials/v1/NCT00718809/events?page=2