Trial · NCT01281865
Everolimus in Combination With Imatinib Mesylate in Treating Patients With Locally Advanced, Locally Recurrent, or Metastatic Soft Tissue Sarcoma
NCT01281865, Phase 1, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2014-10-08
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Everolimus in Combination With Imatinib Mesylate in Treating Patients With Locally Advanced, Locally Recurrent, or Metastatic Soft Tissue Sarcoma. Trials, record NCT01281865. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01281865
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Everolimus in Combination With Imatinib Mesylate in Treating Patients With Locally Advanced, Locally Recurrent, or Metastatic Soft Tissue Sarcoma
- NCT number
- NCT01281865
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 14 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Adult Synovial Sarcoma, Recurrent Adult Soft Tissue Sarcoma, Stage III Adult Soft Tissue Sarcoma, Stage IV Adult Soft Tissue Sarcoma
- Interventions
- diagnostic laboratory biomarker analysis, everolimus, imatinib mesylate
- First posted
- 2011-01-24
- Last updated
- 2014-10-08
- Results first posted
- 2014-10-08
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Response Rate (CR + PR) Assessed by RECIST 1.1 (Phase II) | At 8 weeks |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Response Rate (CR + PR) Assessed by RECIST 1.1 (Phase II) | At 8 weeks | participants | NUMBER |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Response Rate (CR + PR) Assessed by RECIST 1.1 (Phase II) | Arm 1-Treatment (Everolimus and Imatinib Mesylate) | Progression of Disease | 4 | participants | |
| Response Rate (CR + PR) Assessed by RECIST 1.1 (Phase II) | Arm 2-Treatment (Everolimus and Imatinib Mesylate) | Progression of Disease | 1 | participants | |
| Response Rate (CR + PR) Assessed by RECIST 1.1 (Phase II) | Arm 1-Treatment (Everolimus and Imatinib Mesylate) | Stable Disease | 5 | participants | |
| Response Rate (CR + PR) Assessed by RECIST 1.1 (Phase II) | Arm 2-Treatment (Everolimus and Imatinib Mesylate) | Stable Disease | 0 | 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 | Arm 1-Treatment (Everolimus and Imatinib Mesylate) | 12 | |
| Overall Study | STARTED | Arm 2-Treatment (Everolimus and Imatinib Mesylate) | 2 | |
| Overall Study | COMPLETED | Arm 1-Treatment (Everolimus and Imatinib Mesylate) | 9 | |
| Overall Study | COMPLETED | Arm 2-Treatment (Everolimus and Imatinib Mesylate) | 1 | |
| Overall Study | NOT COMPLETED | Arm 1-Treatment (Everolimus and Imatinib Mesylate) | 3 | |
| Overall Study | NOT COMPLETED | Arm 2-Treatment (Everolimus and Imatinib Mesylate) | 1 |
Source ClinicalTrials.gov
Adverse events84
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 | Alanine aminotransferase increased | Investigations | Arm 1-Treatment (Everolimus and Imatinib Mesylate) | 5 | 12 | 28 |
| other | Alanine aminotransferase increased | Investigations | Arm 2-Treatment (Everolimus and Imatinib Mesylate) | 2 | 2 | 4 |
| other | Alkaline phosphatase increased | Investigations | Arm 1-Treatment (Everolimus and Imatinib Mesylate) | 4 | 12 | 24 |
| other | Alkaline phosphatase increased | Investigations | Arm 2-Treatment (Everolimus and Imatinib Mesylate) | 2 | 2 | 6 |
| other | Anemia | Blood and lymphatic system disorders | Arm 1-Treatment (Everolimus and Imatinib Mesylate) | 9 | 12 | 57 |
| other | Anemia | Blood and lymphatic system disorders | Arm 2-Treatment (Everolimus and Imatinib Mesylate) | 2 | 2 | 6 |
| other | Anorexia | Metabolism and nutrition disorders | Arm 1-Treatment (Everolimus and Imatinib Mesylate) | 1 | 12 | 1 |
| other | Anorexia | Metabolism and nutrition disorders | Arm 2-Treatment (Everolimus and Imatinib Mesylate) | 1 | 2 | 1 |
| other | Aspartate aminotransferase increased | Investigations | Arm 1-Treatment (Everolimus and Imatinib Mesylate) | 7 | 12 | 19 |
| other | Aspartate aminotransferase increased | Investigations | Arm 2-Treatment (Everolimus and Imatinib Mesylate) | 2 | 2 | 6 |
1 to 10 of 84Source ClinicalTrials.gov
See all 84 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm 1-Treatment (Everolimus and Imatinib Mesylate) | ||
| Total, all-cause mortality | Arm 2-Treatment (Everolimus and Imatinib Mesylate) | ||
| Total, other adverse events | Arm 1-Treatment (Everolimus and Imatinib Mesylate) | 10 | 12 |
| Total, other adverse events | Arm 2-Treatment (Everolimus and Imatinib Mesylate) | 2 | 2 |
| Total, serious adverse events | Arm 1-Treatment (Everolimus and Imatinib Mesylate) | 2 | 12 |
| Total, serious adverse events | Arm 2-Treatment (Everolimus and Imatinib Mesylate) | 1 | 2 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants2
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 | Source |
|---|---|---|---|---|---|---|
| P30CA008748 | Cancer Center Support Grant | Rudin, Charles M. | SLOAN-KETTERING INST CAN RESEARCH | NATIONAL CANCER INSTITUTE | 1985 to 2026 | NIH RePORTER |
| U01CA069856 | Early Clinical Trials of New Anti-Cancer Agents with Phase 1 Emphasis | SPRIGGS, DAVID R | SLOAN-KETTERING INST CAN RESEARCH | NATIONAL CANCER INSTITUTE | 1995 to 2013 | NIH RePORTER |
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Arm 1-Treatment (Everolimus and Imatinib Mesylate) vs Arm 2-Treatment (Everolimus and Imatinib Mesylate): serious adverse events |
Source 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/NCT01281865
GET https://conductscience.org/api/trials/v1/NCT01281865/events?page=2