Trial · NCT07259317
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent of Patients who Experience Dose Limiting Toxicity (DLT) (Part 1) | Up to 28 days after the first dose of study treatment | The percentage of patients with a DLT is used to estimate maximum tolerated dose (MTD), the most intense dose/schedule among those evaluated at which \<33% of patients experience DLT. |
| Primary | Number of Patients with 1 or More Adverse Events (AEs) Leading to Study Drug Discontinuations or Dose Modifications (Part 1) | Time of first dose up to 30 days after last dose | |
| Primary | Progression-Free Survival (PFS) (Part 2) | From date of enrollment until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 12 months | To evaluate PFS as the time from enrollment until first documented progressive disease (PD) by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 as determined by the Investigator, or death due to any cause, whichever comes first. |
| Secondary | Maximum Plasma Concentration (Cmax) of Relacorilant (Part 1 and Part 2) | Pre- and postdose on Cycle 1 Day 15 (each cycle is 28 days) | |
| Secondary | Area Under the Plasma Concentration-time Curve (AUC) of Relacorilant (Part 1 and Part 2) | Pre- and postdose on Cycle 1 Day 15 (each cycle is 28 days) | |
| Secondary | Cmax of Nab-paclitaxel (Part 1 and Part 2) | At serial timepoints postdose on Cycle 1 Day 15 (each cycle is 28 days) | |
| Secondary | AUC of Nab-paclitaxel (Part 1 and Part 2) | At serial timepoints postdose on Cycle 1 Day 15 (each cycle is 28 days) | |
| Secondary | Overall Survival (OS) (Part 2) | From date of enrollment until the date of death from any cause, whichever comes first, assessed up to 19 months | |
| Secondary | Best Overall Response (BOR) (Part 2) | From date of enrollment until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 12 months | |
| Secondary | Objective Response Rate (ORR) (Part 2) | From date of enrollment until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 12 months | To evaluate the proportion of patients with measurable disease at Baseline who attain complete response (CR) or partial response (PR) by RECIST version 1.1. |
| Secondary | Duration of Response (DoR) (Part 2) | From date of first objective response until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 12 months | To evaluate DOR as the time from the first CR or PR to first documented PD or death, whichever comes first. |
| Secondary | Clinical Benefit Rate (CBR) (Part 2) | Week 24 | To evaluate clinical benefit rate as the proportion of patients who attain CR, PR, or stable disease (SD) at Week 24 as per RECIST version 1.1. |
| Secondary | Cancer Antigen 19-9 (CA19-9) Kinetics (Part 2) | Baseline to Weeks 4, 8, and 16 | To evaluate change in CA19-9 from baseline in patients who had an elevated baseline CA19-9 and change in CA19-9 at Weeks 4, 8, and 16 from baseline in all patients. |
| Secondary | Number of Patients with 1 or More Adverse Events (Part 2) | Time of first dose up to 30 days after last dose | |
| Secondary | Number of Patients with Treatment-related Adverse Events (Part 2) | Time of first dose up to 30 days after last dose | |
| Secondary | Number of Patients with Adverse Events by Severity (Part 2) | Time of first dose up to 30 days after last dose | |
| Secondary | Number of Patients With 1 or More Adverse Events Leading to Study Drug Discontinuation (Part 2) | Time of first dose up to 30 days after last dose |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
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/NCT07259317/registered