Trial · NCT07481383
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 | Safety, Tolerability, and Maximum Tolerated Delivered Dose as Assessed by Adverse Event Reporting | Screening through Week 20 | Incidence of adverse events (AEs), serious adverse events (SAEs), drug- or device-related AEs, and dose-limiting toxicities (DLTs) |
| Primary | Safety, Tolerability, and Maximum Tolerated Delivered Dose as Assessed by Adverse Event Reporting | Screening through Week 20 | Incidence of clinically significant abnormalities in physical examinations |
| Primary | Safety, Tolerability, and Maximum Tolerated Delivered Dose as Assessed by Adverse Event Reporting | Screening through Week 20 | Incidence of clinically significant abnormalities in vital signs |
| Primary | Safety, Tolerability, and Maximum Tolerated Delivered Dose as Assessed by Adverse Event Reporting | Screening through Week 20 | Incidence of clinically significant abnormalities in clinical laboratory tests (clinical chemistry, hematology, urinalysis) |
| Primary | Safety, Tolerability, and Maximum Tolerated Delivered Dose as Assessed by Adverse Event Reporting | Screening through Week 20 | Incidence of clinically significant abnormalities in 12-lead electrocardiograms (ECGs) |
| Secondary | Plasma Pharmacokinetic (PK) Concentrations Assessed by Plasma PK of Gemcitabine Pre- and Post-dose | Screening through Week 8 | Plasma PK of gemcitabine pre- and post-dose as measured by Cmax |
| Secondary | Plasma Pharmacokinetic (PK) Concentrations Assessed by Plasma PK of Gemcitabine Pre- and Post-dose | Screening through Week 8 | Plasma PK of gemcitabine pre- and post-dose as measured by tmax |
| Secondary | Plasma Pharmacokinetic (PK) Concentrations Assessed by Plasma PK of Gemcitabine Pre- and Post-dose | Screening through Week 8 | Plasma PK of gemcitabine pre- and post-dose as measured by t1/2 |
| Secondary | Plasma Pharmacokinetic (PK) Concentrations Assessed by Plasma PK of Gemcitabine Pre- and Post-dose | Screening through Week 8 | Plasma PK of gemcitabine pre- and post-dose as measured by Vd |
| Secondary | Plasma Pharmacokinetic (PK) Concentrations Assessed by Plasma PK of Gemcitabine Pre- and Post-dose | Screening through Week 8 | Plasma PK of gemcitabine pre- and post-dose as measured by AUC0-∞ |
| Secondary | Plasma Pharmacokinetic (PK) Concentrations Assessed by Plasma PK of Gemcitabine Pre- and Post-dose | Screening through Week 8 | Plasma PK of gemcitabine pre- and post-dose as measured by AUCτ |
| Secondary | Plasma Pharmacokinetic (PK) Concentrations Assessed by Plasma PK of Gemcitabine Pre- and Post-dose | Screening through Week 8 | Plasma PK of gemcitabine pre- and post-dose as measured by clearance (CL) |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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/NCT07481383/registered