Trial · NCT01661283
SARC016: Study of Everolimus With Bevacizumab to Treat Refractory Malignant Peripheral Nerve Sheath Tumors
NCT01661283, Phase 2, Completed, Sarcoma Alliance for Research through Collaboration; results first posted 2019-03-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. SARC016: Study of Everolimus With Bevacizumab to Treat Refractory Malignant Peripheral Nerve Sheath Tumors. Trials, record NCT01661283. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01661283
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- SARC016: Study of Everolimus With Bevacizumab to Treat Refractory Malignant Peripheral Nerve Sheath Tumors
- NCT number
- NCT01661283
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 25 participants, actual
- Lead sponsor
- Sarcoma Alliance for Research through Collaboration
- Conditions
- Malignant Peripheral Nerve Sheath Tumors, MPNST, Sarcoma
- Interventions
- everolimus, bevacizumab
- First posted
- 2012-08-09
- Last updated
- 2019-03-06
- Results first posted
- 2019-03-06
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Clinical Benefit Rate (Complete Response, Partial Response, and Stable Disease at ≥ 4 Months Using World Health Organization (WHO) Criteria) of Everolimus in Combination With Bevacizumab | Assessed at Baseline and prior to Cycle 3, 5, 7, 9, etc., for up to 2 years. 1 cycle =28 days | Evaluate if the combination of the mTOR inhibitor everolimus combined with the angiogenesis inhibitor bevacizumab would result in a modest clinical benefit rate, which included confirmed partial and complete responses and disease stability for four or more treatment cycles based on WHO Response Criteria. Per WHO for target lesions: Complete Response (CR): Disappearance of all known disease, determined by two consecutive observations not less than 4 weeks apart. Partial Response (PR): A \> 50% decrease in the total tumor load of the lesions that have been measured to determine the effect of therapy not less than four weeks apart. The observations must be consecutive. Stable Disease (SD): A 50% decrease in total tumor area cannot be established nor has a 25% increase in the size of one or more measurable lesions been demonstrated. |
| Secondary | Spectrum of Germline NF1 Mutations in Individuals With NF1 Associated MPNSTs | greater than or equal to 4 months | To evaluate the spectrum of germline NF1 mutations in individuals with NF1 associated MPNSTs |
| Secondary | Number of Participants With Response Stratified by Individuals With Sporadic or NF1 Associated MPNST | Assessed at Baseline and prior to Cycle 3, 5, 7, 9, etc., for up to 2 years. 1 cycle =28 days | To explore differences in the response rate to everolimus in combination with bevacizumab in individuals with sporadic and NF1 associated MPNST. Responses include confirmed partial and complete responses and disease stability for four or more treatment cycles based on WHO Response Criteria. Per WHO for target lesions: Complete Response (CR): Disappearance of all known disease, determined by two consecutive observations not less than 4 weeks apart. Partial Response (PR): A \> 50% decrease in the total tumor load of the lesions that have been measured to determine the effect of therapy not less than four weeks apart. The observations must be consecutive. Stable Disease (SD): A 50% decrease in total tumor area cannot be established nor has a 25% increase in the size of one or more measurable lesions been demonstrated. |
| Secondary | Relationship Between Response to Everolimus in Combination With Bevacizumab and the Presence of NF1 Mutations or NF1 Inactivation in MPNST Tumor Samples | greater than or equal to 4 months | To explore the relationship between response to everolimus in combination with bevacizumab and the presence of NF1 mutations or NF1 inactivation in MPNST tumor samples |
| Secondary | Vascular Endothelial Growth Factor (VEGF) and Vascular Endothelial Growth Factor Receptor 2 (VEGFR2) Levels at Baseline and Pre-Cycles 3 and 5 | Baseline, Pre-Cycle 3, Pre-Cycle 5 | To assess changes in Vascular Endothelial Growth Factor (VEGF) and Vascular Endothelial Growth Factor Receptor 2 (VEGFR2) Levels in peripheral blood specimens during treatment. |
| Secondary | Utility of 3-D MRI Analysis in Comparison to 1-D and 2-D Measurements to More Sensitively Monitor Response to Everolimus in Combination With Bevacizumab | greater than or equal to 4 months | To evaluate the utility of 3-D MRI analysis in comparison to 1-D and 2-D measurements to more sensitively monitor response to everolimus in combination with bevacizumab |
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 | Clinical Benefit Rate (Complete Response, Partial Response, and Stable Disease at ≥ 4 Months Using World Health Organization (WHO) Criteria) of Everolimus in Combination With Bevacizumab | Assessed at Baseline and prior to Cycle 3, 5, 7, 9, etc., for up to 2 years. 1 cycle =28 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Spectrum of Germline NF1 Mutations in Individuals With NF1 Associated MPNSTs | greater than or equal to 4 months | NF1 germline mutations were not analyzed. | ||
| SECONDARY | Number of Participants With Response Stratified by Individuals With Sporadic or NF1 Associated MPNST | Assessed at Baseline and prior to Cycle 3, 5, 7, 9, etc., for up to 2 years. 1 cycle =28 days | The rows are broken up by patients with NF1 associated MPNST (n=17) and sporadic MPNST (n=8) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Relationship Between Response to Everolimus in Combination With Bevacizumab and the Presence of NF1 Mutations or NF1 Inactivation in MPNST Tumor Samples | greater than or equal to 4 months | Tumor samples were not analyzed for NF1 mutations. | ||
| SECONDARY | Vascular Endothelial Growth Factor (VEGF) and Vascular Endothelial Growth Factor Receptor 2 (VEGFR2) Levels at Baseline and Pre-Cycles 3 and 5 | Baseline, Pre-Cycle 3, Pre-Cycle 5 | Paired samples for analysis were collected for 14 patients at baseline and time of first restaging and 8 patients at time of second restaging. | pg/mL | MEDIAN |
| SECONDARY | Utility of 3-D MRI Analysis in Comparison to 1-D and 2-D Measurements to More Sensitively Monitor Response to Everolimus in Combination With Bevacizumab | greater than or equal to 4 months | Imaging studies of sufficient quality to analyze tumors were not collected. Therefore, unable to analyze volumes and compare 3-D to 1-D and 2-D measurements. |
Source ClinicalTrials.gov
Results by group9
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Clinical Benefit Rate (Complete Response, Partial Response, and Stable Disease at ≥ 4 Months Using World Health Organization (WHO) Criteria) of Everolimus in Combination With Bevacizumab | Treatment | 3 | Participants | ||
| Number of Participants With Response Stratified by Individuals With Sporadic or NF1 Associated MPNST | Treatment | NF1 associated MPNST | 2 | Participants | |
| Number of Participants With Response Stratified by Individuals With Sporadic or NF1 Associated MPNST | Treatment | Sporadic MPNST | 1 | Participants | |
| Vascular Endothelial Growth Factor (VEGF) and Vascular Endothelial Growth Factor Receptor 2 (VEGFR2) Levels at Baseline and Pre-Cycles 3 and 5 | Treatment | VEGF- Baseline | 103.58 | Full Range 31.20 to 593.61 | pg/mL |
| Vascular Endothelial Growth Factor (VEGF) and Vascular Endothelial Growth Factor Receptor 2 (VEGFR2) Levels at Baseline and Pre-Cycles 3 and 5 | Treatment | VEGF- Pre Cycle 3 | 184.24 | Full Range 55.82 to 334.49 | pg/mL |
| Vascular Endothelial Growth Factor (VEGF) and Vascular Endothelial Growth Factor Receptor 2 (VEGFR2) Levels at Baseline and Pre-Cycles 3 and 5 | Treatment | VEGF- Pre Cycle 5 | 192.49 | Full Range 138.51 to 262.94 | pg/mL |
| Vascular Endothelial Growth Factor (VEGF) and Vascular Endothelial Growth Factor Receptor 2 (VEGFR2) Levels at Baseline and Pre-Cycles 3 and 5 | Treatment | VEGFR2- Baseline | 1363.76 | Full Range 1043.25 to 2109.18 | pg/mL |
| Vascular Endothelial Growth Factor (VEGF) and Vascular Endothelial Growth Factor Receptor 2 (VEGFR2) Levels at Baseline and Pre-Cycles 3 and 5 | Treatment | VEGFR2 Pre Cycle 3 | 911.89 | Full Range 658.63 to 1815.49 | pg/mL |
| Vascular Endothelial Growth Factor (VEGF) and Vascular Endothelial Growth Factor Receptor 2 (VEGFR2) Levels at Baseline and Pre-Cycles 3 and 5 | Treatment | VEGFR2 Pre Cycle 5 | 863.85 | Full Range 500.85 to 1678.16 | pg/mL |
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 | 25 | |
| Overall Study | COMPLETED | Treatment | 25 | |
| Overall Study | NOT COMPLETED | Treatment | 0 |
Source ClinicalTrials.gov
Adverse events56
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 | 3 | 25 | 5 |
| other | Platelet count decreased | Blood and lymphatic system disorders | Treatment | 4 | 25 | 6 |
| other | White blood cell decreased | Blood and lymphatic system disorders | Treatment | 3 | 25 | 3 |
| other | Constipation | Gastrointestinal disorders | Treatment | 5 | 25 | 5 |
| other | Diarrhea | Gastrointestinal disorders | Treatment | 3 | 25 | 4 |
| other | Dyspepsia | Gastrointestinal disorders | Treatment | 2 | 25 | 2 |
| other | Mucositis oral | Gastrointestinal disorders | Treatment | 12 | 25 | 20 |
| other | Oral pain | Gastrointestinal disorders | Treatment | 2 | 25 | 4 |
| other | Nausea | Gastrointestinal disorders | Treatment | 7 | 25 | 8 |
| other | Vomiting | Gastrointestinal disorders | Treatment | 5 | 25 | 6 |
1 to 10 of 56Source ClinicalTrials.gov
See all 56 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment | 3 | 25 |
| Total, other adverse events | Treatment | 23 | 25 |
| Total, serious adverse events | Treatment | 11 | 25 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT01661283
GET https://conductscience.org/api/trials/v1/NCT01661283/events?page=2