Trial · NCT04742959
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment | Up to 30 days from study discontinuation | As assessed per NCI Common Toxicity Criteria for Adverse Events, version 5.0 |
| Primary | Dose limiting toxicity (DLT) | Up to 28 days from the first dose | Dose escalation cohorts are monitored and assessed using the NCI Common Toxicity Criteria for Adverse Events, version 5.0. |
| Secondary | Objective Response Rate (ORR) | Through study completion, an average of 9 months. | The proportion of subjects who achieved a complete response (CR) or a partial response (PR) based on RECIST version 1.1. |
| Secondary | Disease Control Rate (DCR) | Through study completion, an average of 9 months. | Defined as CR + PR + stable disease (SD) based on RECIST version 1.1. |
| Secondary | Duration of Objective Response (DOR) | Through study completion, an average of 9 months. | Duration of response for CR or PR based on RECIST version 1.1. |
| Secondary | Progression Free Survival (PFS) | From first study drug administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months | |
| Secondary | Overall Survival (OS) | From first study drug administration until the date of death from any cause, assessed up to 24 months | |
| Secondary | Area under the curve (AUC0-∞) | From Cycle 1 Day 1 to Cycle 2 Day 1 (each cycle is 28 days) | Blood samples will be collected at designated time points for pharmacokinetic analysis of TT-00420 and/or nab-paclitaxel. |
| Secondary | Area under the curve (AUC0-t) | From Cycle 1 Day 1 to Cycle 2 Day 1 (each cycle is 28 days) | Blood samples will be collected at designated time points for pharmacokinetic analysis of TT-00420 and/or nab-paclitaxel. |
| Secondary | Maximum observed concentration (Cmax) | From Cycle 1 Day 1 to Cycle 2 Day 1 (each cycle is 28 days) | Blood samples will be collected at designated time points for pharmacokinetic analysis of TT-00420 and/or nab-paclitaxel. |
| Secondary | Half-life (T1/2) | From Cycle 1 Day 1 to Cycle 2 Day 1 (each cycle is 28 days) | |
| Secondary | Time to Maximum Concentration (Tmax) | From Cycle 1 Day 1 to Cycle 2 Day 1 (each cycle is 28 days) | |
| Secondary | Volume of Distribution (Vd) | From Cycle 1 Day 1 to Cycle 2 Day 1 (each cycle is 28 days) | |
| Other | Genetic Alteration Status | Through study completion, an average of 9 months | Evaluation of biomarkers, including but not limited to, fibroblast growth factor receptor (FGFR) mutation status |
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/NCT04742959/registered