Trial · NCT06167317
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 | The Number of Participants with Dose Limiting Toxicities (DLTs) During Dose Escalation | First dose up to 30 days post last dose (Up to approximately 109 weeks). | DLTs are defined as any of the following treatment-emergent adverse events (AEs) regardless of attribution (graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0), unless clearly related to an underlying disease or extraneous causes, with onset within the DLT-evaluation period for the corresponding dose. |
| Primary | The Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) | First dose up to 30 days post last dose (Up to approximately 109 weeks). | |
| Primary | The Incidence of Laboratory Abnormalities | First dose up to 30 days post last dose (Up to approximately 109 weeks). | |
| Secondary | Pharmacokinetic (PK) Parameter: Area Under the Concentration (AUC)0-24 of GS-0201 | Predose and postdose up to end of treatment (up to 105 weeks) | AUC0-24 is defined as the concentration of drug over time between time 0 and time 24 hours. |
| Secondary | PK Parameter: Cmax of GS-0201 | Predose and postdose up to end of treatment (up to 105 weeks) | Cmax is defined as the maximum observed drug concentration. |
| Secondary | PK Parameter: Tmax of GS-0201 | Predose and postdose up to end of treatment (up to 105 weeks) | Tmax is defined as the time to maximum observed concentration. |
| Secondary | PK Parameter: AUC0-168 of SG (Parts C and D only) | Predose and postdose up to end of treatment (up to 105 weeks) | AUC0-168 is defined as the concentration of drug over time between time 0 and time 168 hours. |
| Secondary | PK Parameter: Cmax of SG (Parts C and D only) | Predose and postdose up to end of treatment (up to 105 weeks) | Cmax is defined as the maximum observed drug concentration. |
| Secondary | PK Parameter: Tmax of SG (Parts C and D only) | Predose and postdose up to end of treatment (up to 105 weeks) | Tmax is defined as the time to maximum observed concentration. |
| Secondary | GS-0201 Plasma Concentrations | Predose and postdose up to end of treatment (up to 105 weeks) | |
| Secondary | Sacituzumab Govitecan (SG) Serum Concentrations (Parts C and D only) | Predose and postdose up to end of treatment (up to 105 weeks) |
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/NCT06167317/registered