Trial · NCT03660930
Nab-Sirolimus and Pazopanib Hydrochloride in Treating Patients With Advanced Nonadipocytic Soft Tissue Sarcomas
NCT03660930, Phase 1, Phase 2, Terminated, University of Washington; results first posted 2024-03-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Nab-Sirolimus and Pazopanib Hydrochloride in Treating Patients With Advanced Nonadipocytic Soft Tissue Sarcomas. Trials, record NCT03660930. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03660930
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Nab-Sirolimus and Pazopanib Hydrochloride in Treating Patients With Advanced Nonadipocytic Soft Tissue Sarcomas
- NCT number
- NCT03660930
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 19 participants, actual
- Lead sponsor
- University of Washington
- Conditions
- Advanced Soft Tissue Sarcoma, Locally Advanced Soft Tissue Sarcoma, Metastatic Soft Tissue Sarcoma
- Interventions
- Sirolimus Albumin-bound Nanoparticles, Pazopanib hydrochloride
- First posted
- 2018-09-07
- Last updated
- 2025-04-30
- Results first posted
- 2024-03-13
- Limitations and caveats
- While the study was originally designed as a phase I/II study, only the phase I component of the study was completed..
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Maximum-tolerated Dose (MTD) of Nab-rapamycin in Combination With Pazopanib (Phase I) - Nab-Rapamycin Dose | First 2 cycles (3-week cycles, 21 days each) | Will be estimated using dose-limiting toxicities (DLTs). Will use a Simon's minimax design. |
| Primary | The Maximum-tolerated Dose (MTD) of Nab-rapamycin in Combination With Pazopanib (Phase I) - Pazopanib Dose | First 2 cycles (3-week cycles, 21 days each) | Will be estimated using dose-limiting toxicities (DLTs). Will use a Simon's minimax design. |
| Primary | Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) | First 2 cycles (3-week cycles, 21 days each) | A DLT is defined as any Grade 3 or greater adverse event (AE), at least possibly related to either or both nab-sirolimus and pazopanib. Only toxicities with a clearly identified and documented alternative explanation may be deemed non-DLT. Dose-limiting toxicities include any death not clearly due to underlying disease or extraneous causes, or persistent intolerable nonhematologic AE of any grade that requires dose reduction or permanent discontinuation of the study drug, in the opinion of the investigator. |
| Primary | Dose Limiting Toxicities | First 2 cycles (3 week cycles, 21 days each) | A Dose-limiting toxicity is defined as any Grade 3 or greater adverse event (AE), at least possibly related to either or both nab-Sirolimus or pazopanib. Only toxicities with clearly identified and documented alternative explanation may be deemed non-DLT. Dose-limiting toxicities include any death not clearly due to underlying disease or extraneous causes, or persistent intolerable nonhematologic Ae of any grade that requires dose reduction or permanent discontinuation of the study drug, in the opinion of the investigator. |
| Primary | Progression-free Survival (PFS) Rate | At 3 months | Will be assessed using Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 where progression is defined as a 20% increase in the sum of the longest diameter of target lesions where the sum must also demonstrate an absolute increase of at least 5 mm, or the appearance of new lesions. Will be assessed via descriptive statistics. |
| Secondary | Incidence of Adverse Events Profile | Up to 30 days after last dose (an average of 41 weeks) | Treatment-related adverse events (AEs) experienced by participants evaluated by Common Terminology Criteria for Adverse Events (CTCAE) 5.0 and determined to be possibly related, probably related, or definitely related to either nab-sirolimus therapy, pazopanib therapy, or both. |
| Secondary | Median PFS | At 6 months | Will be assessed using RECIST v1.1. Will be assessed via descriptive statistics. |
| Secondary | Progression-Free Survival Rate | At 6 months | Will be assessed using Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1. Will be assessed via descriptive statistics. |
| Secondary | Median Overall Survival (OS) | At 12 months | Will be summarized using descriptive statistics. |
| Secondary | Overall Survival | 12 months | Will be assessed using descriptive statistics. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Maximum-tolerated Dose (MTD) of Nab-rapamycin in Combination With Pazopanib (Phase I) - Nab-Rapamycin Dose | First 2 cycles (3-week cycles, 21 days each) | MTD was determined to be ABI-009 on DAY 1 of a 21 day cycle ONLY in combination with daily oral pazopanib. | mg/m^2 | NUMBER |
| PRIMARY | The Maximum-tolerated Dose (MTD) of Nab-rapamycin in Combination With Pazopanib (Phase I) - Pazopanib Dose | First 2 cycles (3-week cycles, 21 days each) | MTD was determined to be ABI-009 on DAY 1 of a 21 day cycle ONLY in combination with daily oral pazopanib. | mg | NUMBER |
| PRIMARY | Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) | First 2 cycles (3-week cycles, 21 days each) | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Dose Limiting Toxicities | First 2 cycles (3 week cycles, 21 days each) | participants | NUMBER | |
| PRIMARY | Progression-free Survival (PFS) Rate | At 3 months | Three Phase I patients were treated at the recommended Phase II dose of 30 mg/m\^2 nab-sirolimus intravenously on Day 1 of a 21-day cycle, with 400 mg of oral daily pazopanib. These three patients were not enrolled in Phase II. | proportion of participants | NUMBER |
| SECONDARY | Incidence of Adverse Events Profile | Up to 30 days after last dose (an average of 41 weeks) | adverse events experienced | NUMBER | |
| SECONDARY | Median PFS | At 6 months | Three Phase I patients were treated at the recommended Phase II dose of 30 mg/m\^2 nab-sirolimus intravenously on Day 1 of a 21-day cycle with 400 mg of oral daily pazopanib. These three patients were not enrolled in Phase II. | months | MEDIAN |
| SECONDARY | Progression-Free Survival Rate | At 6 months | Three Phase I patients were treated at the recommended Phase II dose of 30 mg/m\^2 nab-sirolimus intravenously on Day 1 of a 21-day cycle with 400 mg of oral daily pazopanib. These three patients were not enrolled in Phase II. | proportion of participants | NUMBER |
| SECONDARY | Median Overall Survival (OS) | At 12 months | Three Phase I patients were treated at the recommended Phase II dose of 30 mg/m\^2 nab-sirolimus intravenously on Day 1 of a 21-day cycle with 400 mg of oral daily pazopanib. These three patients were not enrolled in Phase II. | months | MEDIAN |
| SECONDARY | Overall Survival | 12 months | Three Phase I patients were treated at the recommended Phase II dose of 30 mg/m\^2 nab-sirolimus intravenously on Day 1 of a 21-day cycle with 400 mg of oral daily pazopanib. These three patients were not enrolled in Phase II. | proportion of participants | NUMBER |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group122
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Maximum-tolerated Dose (MTD) of Nab-rapamycin in Combination With Pazopanib (Phase I) - Nab-Rapamycin Dose | All Participants | 30 | mg/m^2 | ||
| The Maximum-tolerated Dose (MTD) of Nab-rapamycin in Combination With Pazopanib (Phase I) - Pazopanib Dose | All Participants | 400 | mg | ||
| Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) | Cohort 1, Dose Level 0 | 2 | Participants | ||
| Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) | Cohort 4, Dose Level -1 | 2 | Participants | ||
| Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) | Cohort 5, Dose Level -2 | 2 | Participants | ||
| Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) | Cohort 6, Dose Level 0B | 2 | Participants | ||
| Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) | Cohort 9, Dose Level -1B | 2 | Participants | ||
| Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) | Cohort 10, Dose Level -2B | 2 | Participants | ||
| Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) | Cohort 11, Dose Level 0C | 0 | Participants | ||
| Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) | Cohort 12, Dose Level 1C | 2 | Participants |
1 to 10 of 122Source ClinicalTrials.gov
See all 122 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1, Dose Level 0 | 2 | |
| Overall Study | STARTED | Cohort 4, Dose Level -1 | 2 | |
| Overall Study | STARTED | Cohort 5, Dose Level -2 | 2 | |
| Overall Study | STARTED | Cohort 6, Dose Level 0B | 2 | |
| Overall Study | STARTED | Cohort 9, Dose Level -1B | 2 | |
| Overall Study | STARTED | Cohort 10, Dose Level -2B | 3 | |
| Overall Study | STARTED | Cohort 11, Dose Level 0C | 3 | |
| Overall Study | STARTED | Cohort 12, Dose Level 1C | 3 | |
| Overall Study | COMPLETED | Cohort 1, Dose Level 0 | 2 | |
| Overall Study | COMPLETED | Cohort 4, Dose Level -1 | 2 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events1,056
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 | Platelet Count Decreased | Investigations | Cohort 1, Dose Level 0 | 2 | 2 | 16 |
| other | Platelet Count Decreased | Investigations | Cohort 4, Dose Level -1 | 1 | 2 | 3 |
| other | Platelet Count Decreased | Investigations | Cohort 5, Dose Level -2 | 2 | 2 | 2 |
| other | Platelet Count Decreased | Investigations | Cohort 6, Dose Level 0B | 2 | 2 | 10 |
| other | Platelet Count Decreased | Investigations | Cohort 9, Dose Level -1B | 2 | 2 | 4 |
| other | Platelet Count Decreased | Investigations | Cohort 10, Dose Level -2B | 3 | 3 | 18 |
| other | Platelet Count Decreased | Investigations | Cohort 11, Dose Level 0C | 0 | 3 | 0 |
| other | Platelet Count Decreased | Investigations | Cohort 12, Dose Level 1C | 2 | 3 | 11 |
| other | Neutrophil Count Decreased | Investigations | Cohort 1, Dose Level 0 | 1 | 2 | 7 |
| other | Neutrophil Count Decreased | Investigations | Cohort 4, Dose Level -1 | 1 | 2 | 2 |
1 to 10 of 1,056Source ClinicalTrials.gov
See all 1,056 adverse eventsAdverse event totals24
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1, Dose Level 0 | 0 | 2 |
| Total, all-cause mortality | Cohort 4, Dose Level -1 | 0 | 2 |
| Total, all-cause mortality | Cohort 5, Dose Level -2 | 0 | 2 |
| Total, all-cause mortality | Cohort 6, Dose Level 0B | 0 | 2 |
| Total, all-cause mortality | Cohort 9, Dose Level -1B | 0 | 2 |
| Total, all-cause mortality | Cohort 10, Dose Level -2B | 1 | 3 |
| Total, all-cause mortality | Cohort 11, Dose Level 0C | 0 | 3 |
| Total, all-cause mortality | Cohort 12, Dose Level 1C | 0 | 3 |
| Total, other adverse events | Cohort 1, Dose Level 0 | 2 | 2 |
| Total, other adverse events | Cohort 4, Dose Level -1 | 2 | 2 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse event totalsPapers0
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 |
|---|---|---|---|---|---|
| P30CA015704 | Cancer Center Support Grant | LYNCH, THOMAS JAMES | FRED HUTCHINSON CANCER CENTER | 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/NCT03660930
GET https://conductscience.org/api/trials/v1/NCT03660930/results?page=2