Colorectal Cancer Metastatic Clinical Trial
Official title:
MoTriColor: Phase I/II Study With Galunisertib (LY2157299) Combined With Capecitabine in Patients With Advanced Chemotherapy Resistant Colorectal Cancer and an Activated TGF-beta Signature
Part I of this study is designed to identify the recommended phase 2 dose (RP2D) of the
combination regimen of galunisertib/capecitabine as second line treatment in patients with
5-FU or capecitabine resistant CRC. Part II is designed to obtain proof of principle of the
galunisertib plus capecitabine combination in patients with chemo-resistant CRC. The
combination of galunisertib plus capecitabine will be given as second line therapy in the
phase II part of this study.
Patients with chemotherapy resistant activated TGF-β signature-like tumors will have received
a fluoropyrimidine (5FU or capecitabine) in the first line of chemotherapy, usually combined
with oxaliplatin and, depending upon local hospital preferences or national guidelines, also
bevacizumab, or cetuximab/panitumumab if the tumor is KRAS wild type. Addition of
galunisertib to capecitabine should thus result in reversal of unresponsiveness, which is the
first step in exploring this concept in the clinic. Capecitabine can be used as single agent
in advanced CRC and is thus attractive for this study concept. If proof of principle is
achieved also other tumor types can be explored with this genetic makeup, such as non-small
cell lung cancer (NSCLC) in second line of treatment after platinum doublet therapy in first
line, usually cisplatin/carboplatin-pemetrexed in non-squamous and
cisplatin/carboplatin-gemcitabine or cisplatin/carboplatin-paclitaxel in squamous type NSCLC.
n/a
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