Trial · NCT03660930
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| 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. |
| Secondary | Objective Response Rate (CR + PR) | Up to 2 years | Will be based on RECIST v1.1. Will be evaluated by CT imaging. |
| Secondary | Disease Control Rate (Complete Response [CR] + Partial Response [PR] + Stable Disease [SD]) | at 24 weeks | Will be based on RECIST v1.1evaluated by computed tomography (CT) imaging. Per RECIST V1.1, Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>= 30% decrease in the sum of diameters of target lesions; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD). |
| Secondary | Duration of Response | Up to 2 years | Will be evaluated by CT imaging. |
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.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT03660930/registered