Trial · NCT07570979
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 | Incidence and severity of dose-limiting toxicities (DLTs) | 28 days | A DLT is defined as an adverse event or abnormal laboratory value of Common Terminology Criteria for Adverse Events (CTCAE) grade ≥ 3 that occurs within the first 28 days and not clearly and incontrovertibly assessed as due to disease progression, intercurrent illness, concomitant medication, or extraneous causes with the exceptions defined in the study protocol. Other clinically significant toxicities may be considered to be DLTs, even if not CTCAE grade 3 or higher. |
| Primary | Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to approximately 24 months | Incidence and severity of AEs and SAEs, including changes in laboratory values, vital signs and electrocardiograms (ECGs) qualifying and reported as AEs. |
| Primary | Frequency of dose interruptions and reductions | Up to approximately 24 months | Number of participants with dose interruptions and/or reductions to assess the tolerability. |
| Primary | Dose intensity | Up to approximately 24 months | Dose intensity defined as the ratio of actual cumulative dose received and actual duration of exposure. |
| Secondary | Overall Response Rate (ORR) | Up to approximately 24 months | ORR is defined as proportion of patients achieving a confirmed complete response (CR) or partial response (PR) per Prostate Cancer Working Group 3 (PCWG3)-modified Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) as assessed by the investigator. |
| Secondary | Disease Control Rate (DCR) | Up to approximately 24 months | DCR is defined as proportion of patients achieving a CR, PR or stable disease (SD) per PCWG3-modified RECIST v1.1 as assessed by the investigator. |
| Secondary | Radiological Progression Free Survival (rPFS) | Up to approximately 24 months | rPFS is defined as the time from the date of start of treatment to the date of the first documented radiological progression according to PCWG3-modified RECIST v1.1 or death due to any cause. |
| Secondary | Prostate-Specific Antigen 50% response rate (PSA50 rate) | Up to approximately 24 months | PSA50 rate is defined as the proportion of patients who achieve a ≥50% decrease in prostate-specific antigen (PSA) from baseline at any timepoint, confirmed by a second PSA measurement ≥3 weeks later without any PSA progression in between. |
| Secondary | Area under the plasma concentration-time curve (AUC) of INR731 | From pre-dose up to 24 hours after dosing on Cycle 1 Day 1 and Day 15. One cycle = 28 days. | Pharmacokinetic (PK) parameters based on plasma concentrations of INR731. |
| Secondary | Maximum plasma concentration (Cmax) of INR731 | From pre-dose up to 24 hours after dosing on Cycle 1 Day 1 and Day 15. One cycle = 28 days. | PK parameters based on plasma concentrations of INR731. |
| Secondary | Time to reach maximum plasma concentration (Tmax) of INR731 | From pre-dose up to 24 hours after dosing on Cycle 1 Day 1 and Day 15. One cycle = 28 days. | PK parameters based on plasma concentrations of INR731. |
| Secondary | Trough concentration (Ctrough) of INR731 | From pre-dose up to 24 hours after dosing on Cycle 1 Day 1 and Day 15. One cycle = 28 days. | PK parameters based on plasma concentrations of INR731. |
| Secondary | Plasma concentrations of study drugs | From pre-dose up to 24 hours after dosing on Cycle 1 Day 1 and Day 15. One cycle = 28 days. | Concentration versus time profiles of study drugs. |
| Secondary | Progression Free Survival (PFS) | Up to approximately 24 months | PFS is defined as time from date of start of treatment to the first documented progression (radiological, clinical, or PSA progression) or death from any cause, whichever occurs first. |
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/NCT07570979/registered