Trial · NCT05770882
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Adverse event (AE) | From the first day of treatment until progressive disease or death, assessed up to 12 months | To analyze the frequency, percentage of patients with study medications of adverse events |
| Primary | Maximum tolerated dose(MTD) / maximum feasible dose (MFD) | From start of treatment Cycle1 Day1 until completion of one cycle of treatment (maximum 28 days) | To assess tolerability/feasible of study medications dose |
| Primary | Pharmacokinetics profiles - (AUC0-t) | Blood samples collected on Days 1-4 and 18-21 of Cycle 1, pre-dose and up to 72 hours post-dose (28 days/cycle) | Area under the plasma concentration-time curve from time zero to time t(AUC0-t) |
| Primary | Pharmacokinetics profiles - (AUC0-∞) | Blood samples collected on Days 1-4 and 18-21 of Cycle 1, pre-dose and up to 72 hours post-dose (28 days/cycle) | Area under the plasma concentration-time curve from time zero to infinity(AUC0-∞) |
| Primary | Pharmacokinetics profiles - (Cmax) | Blood samples collected on Days 1-4 and 18-21 of Cycle 1, pre-dose and up to 72 hours post-dose (28 days/cycle) | Maximum plasma concentration(Cmax) |
| Primary | Pharmacokinetics profiles - (Tmax) | Blood samples collected on Days 1-4 and 18-21 of Cycle 1, pre-dose and up to 72 hours post-dose (28 days/cycle) | Time to maximum plasma concentration(Tmax) |
| Primary | Pharmacokinetics profiles - (T1/2) | Blood samples collected on Days 1-4 and 18-21 of Cycle 1, pre-dose and up to 72 hours post-dose (28 days/cycle) | Half-life(T1/2) |
| Primary | Objective response rate (ORR) | Objective Response Rate is assessed every 8 weeks from start of treatment until progressive disease is documented (approximately 6 months) | The percentage of patients with CR and PR of total number of analysis set |
| Primary | Progression-free survival (PFS) | From the first day of treatment until disease progression or death from any cause, assessed up to 12 months | The time from first day of dosing until the date of first objective disease progression or death |
| Secondary | Overall survival (OS) | 1 year | The time from the first day of dosing until the date of death |
| Secondary | Time to progression (TTP) | 1 year | The time from the first day of dosing until the date of progression |
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/NCT05770882/registered