Colorectal Cancer Metastatic Clinical Trial
Official title:
MoTriColor: Phase I/II Study With LY3200882 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 LY3200882/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
LY3200882 plus capecitabine combination in patients with chemo-resistant CRC. The combination
of LY3200882 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 LY3200882
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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