drugset / Trial / NCT02975141
Afatinib and Gemcitabine/Nab-paclitaxel in Metastatic Pancreatic Cancer
Phase 1
Unknown
12 enrolled
PD Dr. med. Volker Heinemann
Technical University of Munich · collabUniversity of Cologne · collab
Non-randomizedParallel-groupOpen-labelOther
Summary
This study sets out to determine the maximum tolerated dose (MTD) of afatinib in combination with gemcitabine/nab-paclitaxel in patients with metastatic pancreatic ductal adenocarcinoma. The identified MTD will serve as recommended phase II dose (RP2D).
Timeline
- Start
- 2016-09
- Primary completion
- 2018-12
- Completion
- 2019-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Afatinib | Small molecule | 30 mg | Oral |
| Subject | Afatinib | Small molecule | 40 mg | Oral |
| Subject | Gemcitabine | Small molecule | 600 mg/m2 | — |
| Subject | Gemcitabine | Small molecule | 800 mg/m2 | — |
| Subject | Gemcitabine | Small molecule | 1000 mg/m2 | — |
| Subject | Paclitaxel | Small molecule | 75 mg/m2 | — |
| Subject | Paclitaxel | Small molecule | 100 mg/m2 | — |
| Subject | Paclitaxel | Small molecule | 125 mg/m2 | — |