Trial · NCT00478426
Sunitinib Malate in Treating Patients With Recurrent or Metastatic Endometrial Cancer
NCT00478426, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2020-02-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Sunitinib Malate in Treating Patients With Recurrent or Metastatic Endometrial Cancer. Trials, record NCT00478426. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00478426
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Sunitinib Malate in Treating Patients With Recurrent or Metastatic Endometrial Cancer
- NCT number
- NCT00478426
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 34 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
Endometrial Adenocarcinoma, Endometrial Endometrioid Adenocarcinoma, Endometrial Serous Adenocarcinoma, Recurrent Uterine Corpus Carcinoma, Stage IVA Uterine Corpus Cancer AJCC v7, Stage IVB Uterine Corpus Cancer AJCC v7, Uterine Carcinosarcoma, Uterine Corpus Carcinosarcoma
- Interventions
- Sunitinib Malate
- First posted
- 2007-05-24
- Last updated
- 2020-02-17
- Results first posted
- 2020-02-17
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 | Up to 7 years | Objective response rate, defined as the rate of complete or partial response as defined by the Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI and/or CT: Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progression of Disease (PD); PD, 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; Complete Response (CR), disappearance of all target lesions. |
| Secondary | Number of Participants With Prolonged Stable Disease | Up to 7 years | Described as the best response of stable disease that is maintained for atleast 6 months |
| Secondary | Overall Survival | Up to 7 years | Estimated using the Kaplan-Meier method. |
| Secondary | Number of Participants With Adverse Effects Assessed by CTCAE Version 3.0 | Up to 7 years | Number of participants that experience at east 1 adverse event while on trial, according to the CTCAE. |
| Secondary | Time to Progression | Up to 7 years | The length of time from the date of diagnosis or the start of treatment for a disease until the disease starts to get worse or spread to other parts of the body. Assessed by Kaplan and Meier method |
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 | Up to 7 years | Of the 33 participants, only 28 were considered evaluable for response. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Prolonged Stable Disease | Up to 7 years | Of the 33 participants, 28 were considered evaluable for response. 5 of these patients were not fully evaluable for the study as they were removed before first radiological assessment but are nonetheless included in denominator for response assessment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Survival | Up to 7 years | Of the 33 participants, 28 were considered evaluable for response. 5 of these patients were not fully evaluable for the study as they were removed before first radiological assessment but are nonetheless included in denominator for response assessment. | months | MEDIAN |
| SECONDARY | Number of Participants With Adverse Effects Assessed by CTCAE Version 3.0 | Up to 7 years | Of the 33 participants, 28 were considered evaluable for response. 5 of these patients were not fully evaluable for the study as they were removed before first radiological assessment but are nonetheless included in denominator for response assessment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Progression | Up to 7 years | months | MEDIAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response Rate | Treatment (Sunitinib Malate) | Partial Response | 6 | Participants | |
| Objective Response Rate | Treatment (Sunitinib Malate) | Stable Disease | 6 | Participants | |
| Objective Response Rate | Treatment (Sunitinib Malate) | Progressive Disease | 16 | Participants | |
| Objective Response Rate | Treatment (Sunitinib Malate) | non-evaluable patient | 5 | Participants | |
| Number of Participants With Prolonged Stable Disease | Treatment (Sunitinib Malate) | 0 | Participants | ||
| Overall Survival | Treatment (Sunitinib Malate) | 19.4 | 95% Confidence Interval 6.2 to 60 | months | |
| Number of Participants With Adverse Effects Assessed by CTCAE Version 3.0 | Treatment (Sunitinib Malate) | 30 | Participants | ||
| Time to Progression | Treatment (Sunitinib Malate) | 3 | 95% Confidence Interval 2.5 to 5.3 | months |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment (Sunitinib Malate) | 34 | |
| Overall Study | COMPLETED | Treatment (Sunitinib Malate) | 33 | |
| Overall Study | NOT COMPLETED | Treatment (Sunitinib Malate) | 1 |
Source ClinicalTrials.gov
Adverse events9
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 | Diarrhea | Gastrointestinal disorders | Treatment (Sunitinib Malate) | 25 | 33 | 25 |
| other | Dyspepsia | Gastrointestinal disorders | Treatment (Sunitinib Malate) | 17 | 33 | 17 |
| other | Oral Mucositis | General disorders | Treatment (Sunitinib Malate) | 17 | 33 | 17 |
| other | Nausea | Gastrointestinal disorders | Treatment (Sunitinib Malate) | 19 | 33 | 19 |
| serious | Neutropenia | Blood and lymphatic system disorders | Treatment (Sunitinib Malate) | 8 | 33 | 8 |
| serious | Anemia | Blood and lymphatic system disorders | Treatment (Sunitinib Malate) | 3 | 33 | 3 |
| serious | Thrombocytopenia | Blood and lymphatic system disorders | Treatment (Sunitinib Malate) | 3 | 33 | 3 |
| serious | Fatigue | General disorders | Treatment (Sunitinib Malate) | 14 | 33 | 14 |
| serious | Hypertension | Cardiac disorders | Treatment (Sunitinib Malate) | 6 | 33 | 6 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (Sunitinib Malate) | 0 | 33 |
| Total, other adverse events | Treatment (Sunitinib Malate) | 30 | 33 |
| Total, serious adverse events | Treatment (Sunitinib Malate) | 30 | 33 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24882554 | RESULT |
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/NCT00478426
GET https://conductscience.org/api/trials/v1/NCT00478426/registered