drugset / Trial / NCT02109445
Study Of PF-03084014 In Combination With Gemcitabine And Nab-Paclitaxel In Patients With Metastatic Pancreatic Adenocarcinoma Not Previously Treated With Anticancer Therapies
RandomizedOpen-labelTreatment
Summary
This study consists of a Phase 1b portion aimed to determine the maximum tolerated dose and the safety profile of PF-03084014 in combination with gemcitabine and nab-paclitaxel followed by a Phase 2 portion to evaluate the efficacy of the triple combination in terms of overall survival in patients with metastatic pancreatic ductal adenocarcinoma not previously treated with anticancer therapies.
Timeline
- Start
- 2014-09-03
- Primary completion
- 2014-11-06
- Completion
- 2014-11-06
Outcome
Outcome not reported
Stopped (Business): “The study was terminated on 24JUN15 due to change in strategy of PF-03084014 development.No safety/efficacy concerns were behind the reason of trial termination”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nirogacestat | Small molecule | 100 mg | Oral |
| Subject | Nirogacestat | Small molecule | 150 mg | Oral |
| Comparator | Gemcitabine | Small molecule | 1000 mg/m2 | Intravenous |
| Comparator | Nab-paclitaxel | Small molecule | 125 mg/m2 | Intravenous |