Trial · NCT04511039
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of Adverse Events | after each cycle of treatment ( 1 cycle = 14 days) | All adverse events will be evaluated using Common Terminology Criteria for All Adverse Events (CTCAE) version (v.) 5. |
| Primary | Maximum tolerated dose/ recommended phase II dose | Up to 14 days | Will utilize the keyboard design - a novel model- assisted dose-finding method to find the maximum tolerated dose |
| Secondary | Plasma Concentration (Cmax) | Day -13 post dose | The pharmacokinetic parameters between Trifluridine/Tipiracil and Talazoparib will be evaluated on Day -14: pre-dose, 0.5, 1, 2, 4, 6, 8 hours (hr) post-dose; day-13: 24 hr post-initial dose and day -13 pre-dose |
| Secondary | Plasma Concentration (Cmax) | day -14 pre dose | The pharmacokinetic parameters between Trifluridine/Tipiracil and Talazoparib will be evaluated on Day -14: pre-dose, 0.5, 1, 2, 4, 6, 8 hours (hr) post-dose; day-13: 24 hr post-initial dose and day -13 pre-dose |
| Secondary | Plasma Concentration (Cmax) | day -14 post dose | The pharmacokinetic parameters between Trifluridine/Tipiracil and Talazoparib will be evaluated on Day -14: pre-dose, 0.5, 1, 2, 4, 6, 8 hours (hr) post-dose; day-13: 24 hr post-initial dose and day -13 pre-dose |
| Secondary | Plasma Concentration (Cmax) | day -13 pre dose | The pharmacokinetic parameters between Trifluridine/Tipiracil and Talazoparib will be evaluated on Day -14: pre-dose, 0.5, 1, 2, 4, 6, 8 hours (hr) post-dose; day-13: 24 hr post-initial dose and day -13 pre-dose |
| Secondary | Overall Response Rate (ORR) | Up to 3 years | Will be summarized using frequencies and relative frequencies. |
| Secondary | CEA response rate (colorectal cancer patients) | Up to 3 years | ill be summarized using frequencies and relative frequencies. . |
| Secondary | Progression Free Survival (PFS) | From treatment until disease progression UP to 3 years | Will be summarized using standard Kaplan-Meier methods |
| Secondary | Overall Survival (OS) | From treatment until death or up to 3 years | Will be summarized using standard Kaplan-Meier methods |
| Secondary | Progressive Disease Assessment (PD) | Up to 3 years | |
| Secondary | Number of subjects with DNA damage response | Up to 28 days prior to first drug dose, on treatment and between cylce 1-day 8 and cycle 1 day 12 | Tumor biopsies will be summarized by dose level and time-point using means and standard deviations. |
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/NCT04511039/registered