TRICC-C (AIO-KRK-0111): BIBF 1120 Versus Placebo in Patients Receiving Oxaliplatin Plus Fluorouracil and Leucovorin (mFOLFOX6) for Advanced, Chemorefractory Metastatic Colorectal Cancer (mCRC)

Phase 2 Completed 54 enrolled Martin-Luther-University Halle-Wittenberg GALMED GmbH · collab

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study: To explore the comparative effectiveness of BIBF 1120 in terms of : * Progression-free survival (PFS), objective response, overall survival * Evaluate and compare safety

Timeline

Start: 2011-06
Primary completion: 2016-06
Completion: 2016-12

Publications

Ettrich TJ, Perkhofer L, Decker T, Hofheinz RD, Heinemann V, Hoffmann T, Hebart HF, Herrmann T, Hannig CV, Buchner-Steudel P, Guthle M, Hermann PC, Berger AW, Seufferlein T. Nintedanib plus mFOLFOX6 as second-line treatment of metastatic, chemorefractory colorectal cancer: The randomised, placebo-controlled, phase II TRICC-C study (AIO-KRK-0111). Int J Cancer. 2021 Mar 15;148(6):1428-1437. doi: 10.1002/ijc.33296. Epub 2020 Oct 4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Nintedanib	Small molecule	200 mg	Oral
Background	Leucovorin	Small molecule	—	—
Background	Oxaliplatin	Small molecule	—	—
Background	fluorouracil	Small molecule	—	—

TRICC-C (AIO-KRK-0111): BIBF 1120 Versus Placebo in Patients Receiving Oxaliplatin Plus Fluorouracil and Leucovorin (mFOLFOX6) for Advanced, Chemorefractory Metastatic Colorectal Cancer (mCRC)

Summary

Timeline

Publications

Drugs

Indications