drugset / Trial / NCT03688230
Study of Abituzumab in Combination With Cetuximab and FOLFIRI in Patients With Metastatic Colorectal Cancer.
Phase 2
Withdrawn
SFJ Pharmaceuticals X, LTD.
AIO-Studien-gGmbH · collabAcademic and Community Cancer Research United · collabMerck KGaA, Darmstadt, Germany · collabSFJ Pharmaceuticals, Inc. · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this study is to evaluate the safety and efficacy of the experimental drug abituzumab (EMD525797) in combination with cetuximab and FOLFIRI in RAS wild-type, left-sided, metastatic colorectal cancer patients with high ανβ6 integrin expression.
Timeline
- Start
- 2019-04
- Primary completion
- 2020-12
- Completion
- 2021-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Abituzumab | Monoclonal antibody | 1000 mg | Intravenous |
| Background | Cetuximab | Monoclonal antibody | 250 mg/m2 | — |
| Background | Cetuximab | Monoclonal antibody | 500 mg/m2 | — |
| Background | Irinotecan | Small molecule | 180 mg/m2 | Intravenous |
| Background | Leucovorin | Small molecule | 400 mg/m2 | Intravenous |
| Background | fluorouracil | Small molecule | 400 mg/m2 | Intravenous |
| Background | fluorouracil | Small molecule | 2400 mg/m2 | Intravenous |