Trial · NCT01016015
Temsirolimus and Cixutumumab in Treating Patients With Locally Advanced, Metastatic, or Recurrent Soft Tissue Sarcoma or Bone Sarcoma
NCT01016015, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2015-07-30
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Temsirolimus and Cixutumumab in Treating Patients With Locally Advanced, Metastatic, or Recurrent Soft Tissue Sarcoma or Bone Sarcoma. Trials, record NCT01016015. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01016015
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Temsirolimus and Cixutumumab in Treating Patients With Locally Advanced, Metastatic, or Recurrent Soft Tissue Sarcoma or Bone Sarcoma
- NCT number
- NCT01016015
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 178 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Metastatic Osteosarcoma, Recurrent Adult Soft Tissue Sarcoma, Recurrent Osteosarcoma, Stage III Adult Soft Tissue Sarcoma, Stage IV Adult Soft Tissue Sarcoma
- Interventions
- Cixutumumab, Laboratory Biomarker Analysis, Temsirolimus
- First posted
- 2009-11-18
- Last updated
- 2015-07-30
- Results first posted
- 2015-07-30
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival Rate, Defined as CR + PR + SD, as Assessed by RECIST Criteria | From study entry until recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurement recorded on study), death or date of last contact, assessed at 12 weeks | From study entry until recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurement recorded on study), death or date of last contact, assessed at 12 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 | Progression-free Survival Rate, Defined as CR + PR + SD, as Assessed by RECIST Criteria | From study entry until recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurement recorded on study), death or date of last contact, assessed at 12 weeks | participants | NUMBER |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-free Survival Rate, Defined as CR + PR + SD, as Assessed by RECIST Criteria | Cixutumumab and Temsirolimus | Partial Response | 4 | participants | |
| Progression-free Survival Rate, Defined as CR + PR + SD, as Assessed by RECIST Criteria | Cixutumumab and Temsirolimus | Progression of Disease | 57 | participants | |
| Progression-free Survival Rate, Defined as CR + PR + SD, as Assessed by RECIST Criteria | Cixutumumab and Temsirolimus | Stable Disease | 98 | 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 | Cixutumumab and Temsirolimus | 178 | |
| Overall Study | COMPLETED | Cixutumumab and Temsirolimus | 159 | |
| Overall Study | NOT COMPLETED | Cixutumumab and Temsirolimus | 19 |
Source ClinicalTrials.gov
Adverse events95
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 | Activated partial thromboplastin time prolonged | Investigations | Cixutumumab and Temsirolimus | 14 | 175 | 25 |
| other | Alanine aminotransferase | Investigations | Cixutumumab and Temsirolimus | 32 | 175 | 60 |
| other | Alkaline phosphatase increased | Investigations | Cixutumumab and Temsirolimus | 32 | 175 | 175 |
| other | Aspartate aminotransferase increased | Investigations | Cixutumumab and Temsirolimus | 31 | 175 | 132 |
| other | Blood Bilirubin increased | Investigations | Cixutumumab and Temsirolimus | 12 | 175 | 29 |
| other | Cholesterol, High | Investigations | Cixutumumab and Temsirolimus | 41 | 175 | 139 |
| other | Creatinine increased | Investigations | Cixutumumab and Temsirolimus | 19 | 175 | 192 |
| other | Hyperglycemia | Metabolism and nutrition disorders | Cixutumumab and Temsirolimus | 61 | 175 | 915 |
| other | Hyperkalemia | Metabolism and nutrition disorders | Cixutumumab and Temsirolimus | 8 | 175 | 21 |
| other | Hypertriglyceridemia | Metabolism and nutrition disorders | Cixutumumab and Temsirolimus | 40 | 175 | 159 |
1 to 10 of 95Source ClinicalTrials.gov
See all 95 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cixutumumab and Temsirolimus | ||
| Total, other adverse events | Cixutumumab and Temsirolimus | 62 | 175 |
| Total, serious adverse events | Cixutumumab and Temsirolimus | 83 | 175 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23477833 | DERIVED |
Source PubMed
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 |
|---|---|---|---|---|---|
| P30CA008748 | Cancer Center Support Grant | Rudin, Charles M. | SLOAN-KETTERING INST CAN RESEARCH | NATIONAL CANCER INSTITUTE | 1985 to 2026 |
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/NCT01016015
GET https://conductscience.org/api/trials/v1/NCT01016015/events?page=2