Trial · NCT01621568
Sunitinib for Advanced Thymus Cancer Following Earlier Treatment
NCT01621568, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2022-06-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Sunitinib for Advanced Thymus Cancer Following Earlier Treatment. Trials, record NCT01621568. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01621568
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Sunitinib for Advanced Thymus Cancer Following Earlier Treatment
- NCT number
- NCT01621568
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 56 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Thymoma, Thymus Neoplasms
- Interventions
- Sunitinib, Sunitinib
- First posted
- 2012-06-18
- Last updated
- 2024-09-24
- Results first posted
- 2022-06-07
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With an Objective Response (Partial Response (PR) + Complete Response (CR) for Sunitinib in Participants With Relapsed or Refractory Thymoma or Thymic Carcinoma | A median duration of 6 months | Objective response rate (CR + PR) will be measured according to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria for sunitinib monotherapy in participants with advanced thymic malignancies. Complete response is disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. |
| Secondary | Progression-free Survival for Sunitinib in Participants With Relapsed or Refractory Thymoma or Thymic Carcinoma | An average of 10 months | Progression free survival is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. Progression was measured by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and is defined as at least a 20% increase in the sum of the diameters of target lesion, taking as reference the smallest sum on study; and the appearance of one or more new lesions. |
| Secondary | Number of Participants Alive at 1 Year After Treatment With Sunitinib | 12 months after initiation of treatment | Number of participants alive at 1 year after treatment with sunitinib. |
| Secondary | Number of Grades ≥3 Adverse Events Related to Sunitinib | Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group. | Adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). Grade 3 is severe. Grade 4 is life-threatening. Grade 5 is death related to adverse event. |
| Other | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). | Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group. | Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. |
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 | Percentage of Participants With an Objective Response (Partial Response (PR) + Complete Response (CR) for Sunitinib in Participants With Relapsed or Refractory Thymoma or Thymic Carcinoma | A median duration of 6 months | 2/41 participants were not evaluable in group 1 thymoma and thymic carcinoma. 1/16 participants in group 2 thymic carcinoma were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for this outcome measure. | percentage of participants | NUMBER |
| SECONDARY | Progression-free Survival for Sunitinib in Participants With Relapsed or Refractory Thymoma or Thymic Carcinoma | An average of 10 months | 2/41 participants were not evaluable in group 1 thymoma and thymic carcinoma. 1/16 participants in group 2 thymic carcinoma were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for this outcome measure. | Months | MEDIAN |
| SECONDARY | Number of Participants Alive at 1 Year After Treatment With Sunitinib | 12 months after initiation of treatment | 2/41 participants were not evaluable in group 1 thymoma and thymic carcinoma. 1/16 participants in group 2 thymic carcinoma were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Grades ≥3 Adverse Events Related to Sunitinib | Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group. | For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups. | Adverse events | NUMBER |
| OTHER_PRE_SPECIFIED | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). | Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group. | 1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group20
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 an Objective Response (Partial Response (PR) + Complete Response (CR) for Sunitinib in Participants With Relapsed or Refractory Thymoma or Thymic Carcinoma | Group 1 (Thymoma Carcinoma) 50 mg/Day | Complete Response | 0 | 95% Confidence Interval 0 to 0 | percentage of participants |
| Percentage of Participants With an Objective Response (Partial Response (PR) + Complete Response (CR) for Sunitinib in Participants With Relapsed or Refractory Thymoma or Thymic Carcinoma | Group 1 (Thymic Carcinoma) 50 mg/Day | Complete Response | 0 | 95% Confidence Interval 0 to 0 | percentage of participants |
| Percentage of Participants With an Objective Response (Partial Response (PR) + Complete Response (CR) for Sunitinib in Participants With Relapsed or Refractory Thymoma or Thymic Carcinoma | Group 2 (Thymic Carcinoma Only) 50 mg/Day | Complete Response | 0 | 95% Confidence Interval 0 to 0 | percentage of participants |
| Percentage of Participants With an Objective Response (Partial Response (PR) + Complete Response (CR) for Sunitinib in Participants With Relapsed or Refractory Thymoma or Thymic Carcinoma | Group 1 (Thymoma Carcinoma) 50 mg/Day | Partial Response | 6 | 95% Confidence Interval 0.2 to 30.2 | percentage of participants |
| Percentage of Participants With an Objective Response (Partial Response (PR) + Complete Response (CR) for Sunitinib in Participants With Relapsed or Refractory Thymoma or Thymic Carcinoma | Group 1 (Thymic Carcinoma) 50 mg/Day | Partial Response | 26 | 95% Confidence Interval 10.2 to 48.4 | percentage of participants |
| Percentage of Participants With an Objective Response (Partial Response (PR) + Complete Response (CR) for Sunitinib in Participants With Relapsed or Refractory Thymoma or Thymic Carcinoma | Group 2 (Thymic Carcinoma Only) 50 mg/Day | Partial Response | 8 | 95% Confidence Interval 0.2 to 36.0 | percentage of participants |
| Progression-free Survival for Sunitinib in Participants With Relapsed or Refractory Thymoma or Thymic Carcinoma | Group 1 (Thymoma Carcinoma) 50 mg/Day | 8.5 | 95% Confidence Interval 2.8 to 11.3 | Months | |
| Progression-free Survival for Sunitinib in Participants With Relapsed or Refractory Thymoma or Thymic Carcinoma | Group 1 (Thymic Carcinoma) 50 mg/Day | 7.2 | 95% Confidence Interval 3.4 to 15.2 | Months | |
| Progression-free Survival for Sunitinib in Participants With Relapsed or Refractory Thymoma or Thymic Carcinoma | Group 2 (Thymic Carcinoma Only) 50 mg/Day | 5.0 | 95% Confidence Interval 2.7 to 5.5 | Months | |
| Number of Participants Alive at 1 Year After Treatment With Sunitinib | Group 1 (Thymoma Carcinoma) 50 mg/Day | 14 | Participants |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Week 1-4 | STARTED | Treatment: Weeks 1-4, Group 1; Weeks 1-2, Group 2 | 41 | |
| Treatment Week 1-4 | STARTED | No Treatment: Weeks 5-6, Group 1; Week 3, Group 2 | 15 | |
| Treatment Week 1-4 | COMPLETED | Treatment: Weeks 1-4, Group 1; Weeks 1-2, Group 2 | 41 | |
| Treatment Week 1-4 | COMPLETED | No Treatment: Weeks 5-6, Group 1; Week 3, Group 2 | 15 | |
| Treatment Week 1-4 | NOT COMPLETED | Treatment: Weeks 1-4, Group 1; Weeks 1-2, Group 2 | 0 | |
| Treatment Week 1-4 | NOT COMPLETED | No Treatment: Weeks 5-6, Group 1; Week 3, Group 2 | 0 | |
| Week 5-6 No Treatment | STARTED | Treatment: Weeks 1-4, Group 1; Weeks 1-2, Group 2 | 41 | |
| Week 5-6 No Treatment | STARTED | No Treatment: Weeks 5-6, Group 1; Week 3, Group 2 | 15 | |
| Week 5-6 No Treatment | COMPLETED | Treatment: Weeks 1-4, Group 1; Weeks 1-2, Group 2 | 39 | |
| Week 5-6 No Treatment | COMPLETED | No Treatment: Weeks 5-6, Group 1; Week 3, Group 2 | 15 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events524
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 pain | Gastrointestinal disorders | Treatment: Weeks 1-4, Group 1; Weeks 1-2, Group 2 | 8 | 41 | 9 |
| other | Abdominal pain | Gastrointestinal disorders | No Treatment: Weeks 5-6, Group 1; Week 3, Group 2 | 2 | 15 | 5 |
| other | Activated partial thromboplastin time prolonged | Investigations | Treatment: Weeks 1-4, Group 1; Weeks 1-2, Group 2 | 2 | 41 | 2 |
| other | Activated partial thromboplastin time prolonged | Investigations | No Treatment: Weeks 5-6, Group 1; Week 3, Group 2 | 1 | 15 | 1 |
| other | Agitation | Psychiatric disorders | Treatment: Weeks 1-4, Group 1; Weeks 1-2, Group 2 | 1 | 41 | 1 |
| other | Agitation | Psychiatric disorders | No Treatment: Weeks 5-6, Group 1; Week 3, Group 2 | 0 | 15 | 0 |
| other | Alanine aminotransferase increased | Investigations | Treatment: Weeks 1-4, Group 1; Weeks 1-2, Group 2 | 20 | 41 | 35 |
| other | Alanine aminotransferase increased | Investigations | No Treatment: Weeks 5-6, Group 1; Week 3, Group 2 | 2 | 15 | 4 |
| other | Alkaline phosphatase increased | Investigations | Treatment: Weeks 1-4, Group 1; Weeks 1-2, Group 2 | 13 | 41 | 17 |
| other | Alkaline phosphatase increased | Investigations | No Treatment: Weeks 5-6, Group 1; Week 3, Group 2 | 2 | 15 | 3 |
1 to 10 of 524Source ClinicalTrials.gov
See all 524 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment: Weeks 1-4, Group 1; Weeks 1-2, Group 2 | 38 | 41 |
| Total, all-cause mortality | No Treatment: Weeks 5-6, Group 1; Week 3, Group 2 | 15 | 15 |
| Total, other adverse events | Treatment: Weeks 1-4, Group 1; Weeks 1-2, Group 2 | 40 | 41 |
| Total, other adverse events | No Treatment: Weeks 5-6, Group 1; Week 3, Group 2 | 15 | 15 |
| Total, serious adverse events | Treatment: Weeks 1-4, Group 1; Weeks 1-2, Group 2 | 38 | 41 |
| Total, serious adverse events | No Treatment: Weeks 5-6, Group 1; Week 3, Group 2 | 15 | 15 |
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
Treatment: Weeks 1-4, Group 1; Weeks 1-2, Group 2 vs No Treatment: Weeks 5-6, Group 1; Week 3, Group 2: Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). | Trial comparisons |
| Treatment: Weeks 1-4, Group 1; Weeks 1-2, Group 2 vs No Treatment: Weeks 5-6, Group 1; Week 3, Group 2: deaths from any cause | Trial comparisons |
| Treatment: Weeks 1-4, Group 1; Weeks 1-2, Group 2 vs No Treatment: Weeks 5-6, Group 1; Week 3, Group 2: 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/NCT01621568
GET https://conductscience.org/api/trials/v1/NCT01621568/events?page=2