colorectal cancer
Conditions
Brief summary
The primary aim of phase I of the current study is to determine safety and the RP2D of galunisertib plus capecitabine in patients with chemotherapy resistant CRC with PM. The primary aim of phase 2 is to determine the anti-tumor activity, as measured by ORR of galunisertib in combination with capecitabine in patients with chemotherapy resistant CRC with PM.
Detailed description
- To characterize the safety and tolerability of galunisertib in combination with chemotherapy regimens, as assessed by the incidence and severity of adverse events - To asses anti-tumor activity of galunisertib in combination with chemotherapy, as measured by DOR, TTR, PFS and OS (phase II only) - To determine the pharmacokinetic profile of galunisertib in combination with chemotherapy, as measured by plasma concentrations
Interventions
DRUGCapecitabine medac 150 mg film-coated tablets
DRUGLY2157299 80-150
DRUGCapecitabine medac 500 mg film-coated tablets
Sponsors
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary aim of phase I of the current study is to determine safety and the RP2D of galunisertib plus capecitabine in patients with chemotherapy resistant CRC with PM. The primary aim of phase 2 is to determine the anti-tumor activity, as measured by ORR of galunisertib in combination with capecitabine in patients with chemotherapy resistant CRC with PM. | — |
Secondary
| Measure | Time frame |
|---|---|
| - To characterize the safety and tolerability of galunisertib in combination with chemotherapy regimens, as assessed by the incidence and severity of adverse events - To asses anti-tumor activity of galunisertib in combination with chemotherapy, as measured by DOR, TTR, PFS and OS (phase II only) - To determine the pharmacokinetic profile of galunisertib in combination with chemotherapy, as measured by plasma concentrations | — |
Countries
Netherlands
Outcome results
None listed