Trial · NCT01061606
Temsirolimus in Treating Patients With Recurrent or Persistent Cancer of the Uterus
NCT01061606, Phase 2, Terminated, National Cancer Institute (NCI); results first posted 2016-11-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Temsirolimus in Treating Patients With Recurrent or Persistent Cancer of the Uterus. Trials, record NCT01061606. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01061606
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Temsirolimus in Treating Patients With Recurrent or Persistent Cancer of the Uterus
- NCT number
- NCT01061606
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 8 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Recurrent Uterine Sarcoma, Uterine Carcinosarcoma
- Interventions
- temsirolimus
- First posted
- 2010-02-03
- Last updated
- 2016-11-09
- Results first posted
- 2016-11-09
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Tumor Response Rate, in Terms of the Proportion of Confirmed Tumor Responses (CR or PR) Assessed Using RECIST | Up to 3 years | |
| Primary | Progression Free Survival | 6 months from registration | The 6-month progression-free rate is defined as the total number of efficacy-evaluable patients on study without documentation of disease progression 6 months from registration divided by the total number of efficacy-evaluable patients enrolled on study. |
| Secondary | Overall Survival | From registration to death, assessed up to 3 years | Time to event distributions will be estimated using the Kaplan-Meier method. |
| Secondary | Duration of Response, Defined for All Evaluable Patients Who Have Achieved an Objective Response as the Date at Which the Patient's Objective Status is First Noted to be Either a CR or PR to the Date Progression is Documented | Up to 3 years | Median duration of response and the confidence interval for the median duration will be computed. |
| Secondary | Time to Treatment Failure | From study registration to the date patients end treatment, assessed up to 3 years | Time to treatment failure will be evaluated using the method of Kaplan-Meier. |
| Secondary | Time to Progression | Time to progression is defined as the time from registration to disease progression. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Tumor Response Rate, in Terms of the Proportion of Confirmed Tumor Responses (CR or PR) Assessed Using RECIST | Up to 3 years | participants | NUMBER | |
| PRIMARY | Progression Free Survival | 6 months from registration | The study concluded terminated early and patients were not followed. | ||
| SECONDARY | Overall Survival | From registration to death, assessed up to 3 years | The study concluded terminated early and patients were not followed. | ||
| SECONDARY | Duration of Response, Defined for All Evaluable Patients Who Have Achieved an Objective Response as the Date at Which the Patient's Objective Status is First Noted to be Either a CR or PR to the Date Progression is Documented | Up to 3 years | The study concluded terminated early and patients were not followed. | ||
| SECONDARY | Time to Treatment Failure | From study registration to the date patients end treatment, assessed up to 3 years | The study concluded terminated early and patients were not followed. | ||
| SECONDARY | Time to Progression | Time to progression is defined as the time from registration to disease progression. | The study concluded terminated early and patients were not followed. |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Tumor Response Rate, in Terms of the Proportion of Confirmed Tumor Responses (CR or PR) Assessed Using RECIST | Treatment (Temsirolimus) | Disease progression | 4 | participants | |
| Tumor Response Rate, in Terms of the Proportion of Confirmed Tumor Responses (CR or PR) Assessed Using RECIST | Treatment (Temsirolimus) | Stable disease | 2 | participants |
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 (Temsirolimus) | 8 | |
| Overall Study | COMPLETED | Treatment (Temsirolimus) | 0 | |
| Overall Study | NOT COMPLETED | Treatment (Temsirolimus) | 8 |
Source ClinicalTrials.gov
Adverse events50
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 | Anemia | Blood and lymphatic system disorders | Treatment (Temsirolimus) | 3 | 8 | 3 |
| other | Myalgia | Musculoskeletal and connective tissue disorders | Treatment (Temsirolimus) | 2 | 8 | 2 |
| other | Dysgeusia | Nervous system disorders | Treatment (Temsirolimus) | 2 | 8 | 2 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Treatment (Temsirolimus) | 1 | 8 | 1 |
| other | Allergic Rhinitis | Respiratory, thoracic and mediastinal disorders | Treatment (Temsirolimus) | 1 | 8 | 1 |
| other | Left eye twitching | Eye disorders | Treatment (Temsirolimus) | 1 | 8 | 1 |
| other | Tinnitus | Ear and labyrinth disorders | Treatment (Temsirolimus) | 1 | 8 | 1 |
| other | Rasch: acneiform | Skin and subcutaneous tissue disorders | Treatment (Temsirolimus) | 1 | 8 | 1 |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Treatment (Temsirolimus) | 1 | 8 | 1 |
| other | Dry skin | Skin and subcutaneous tissue disorders | Treatment (Temsirolimus) | 1 | 8 | 1 |
1 to 10 of 50Source ClinicalTrials.gov
See all 50 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (Temsirolimus) | ||
| Total, other adverse events | Treatment (Temsirolimus) | 8 | 8 |
| Total, serious adverse events | Treatment (Temsirolimus) | 5 | 8 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA013330 | Cancer Center Support Grant | STEIDL, ULRICH | ALBERT EINSTEIN COLLEGE OF MEDICINE | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
Source NIH RePORTER
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/NCT01061606
GET https://conductscience.org/api/trials/v1/NCT01061606/events?page=2