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Brief Title: Galunisertib and Capecitabine in Advanced Resistant TGF-beta Activated Colorectal Cancer
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
Study ID: NCT03470350
Brief Summary: 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Antoni van Leeuwenhoek (NKI-AVL), Amsterdam, Noord-Holland, Netherlands
Name: J Tabernero, Prof
Affiliation: VHIO
Role: PRINCIPAL_INVESTIGATOR
Name: R Salazar, MD, PhD
Affiliation: ICO
Role: PRINCIPAL_INVESTIGATOR
Name: R Bernards, Prof
Affiliation: Agendia
Role: PRINCIPAL_INVESTIGATOR
Name: S Siena, Prof
Affiliation: ONCG
Role: PRINCIPAL_INVESTIGATOR
Name: A Cervantes, Prof
Affiliation: INCLIVA
Role: PRINCIPAL_INVESTIGATOR
Name: F Ciardiello, Prof
Affiliation: Unina2
Role: PRINCIPAL_INVESTIGATOR
Name: A Bardelli, Prof
Affiliation: UNITO
Role: PRINCIPAL_INVESTIGATOR
Name: S Tejpar, Prof
Affiliation: UZ Leuven
Role: PRINCIPAL_INVESTIGATOR