Trial · NCT03660930
Outcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| 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 |
| SECONDARY | Objective Response Rate (CR + PR) | Up to 2 years | 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 | Disease Control Rate (Complete Response [CR] + Partial Response [PR] + Stable Disease [SD]) | at 24 weeks | 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 | Duration of Response | Up to 2 years | 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 |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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