drugset / Trial / NCT04329949
Study of Relacorilant in Combination With Nab-Paclitaxel in Patients With Metastatic Pancreatic Ductal Adenocarcinoma
NaSingle-groupOpen-labelTreatment
Summary
This is a Phase 3, open-label study to evaluate the objective response rate (ORR), in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC) treated with relacorilant in combination with nab-paclitaxel, according to blinded independent central review.
Timeline
- Start
- 2020-06-30
- Primary completion
- 2021-08-23
- Completion
- 2022-03-25
Outcome
Outcome not reported
Stopped: “The independent data monitoring committee found no safety issues, however the observed response rate did not meet the predefined threshold for continuing the study. The study was terminated by the Sponsor.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Relacorilant | Small molecule | 25 mg | Oral |
| Subject | Relacorilant | Small molecule | 100 mg | Oral |
| Background | Nab-paclitaxel | Small molecule | — | Intravenous |