metastatic colorectal cancer with a proven RAS mutation after failure of standard systemic treatment regimens including at least 5- FU/capecitabine-oxaliplatin and irinotecan based standard treatment (unless contra-indications for either oxaliplatin or irinotecan)
Conditions
Brief summary
For the phase I dose-escalation trial, the primary endpoint is the incidence of DLTs leading to a RP2D. The RP2D of the triplet will be the MTD which is defined as the dose level that can be given to 6 subjects such that not more than 1 subject experiences a DLT, For the phase II trial the primary endpoint is objective response rate according to RECIST 1.1
Detailed description
the pharmacokinetic profile of the triple combination, safety and tolerability (frequencies of AEs, dose reductions) and additional anti-tumor efficacy parameters including clinical benefit rate and progression-free survival
Interventions
DRUGVinorelbine Accord 10 mg/ml concentraat voor oplossing voor infusie
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| For the phase I dose-escalation trial, the primary endpoint is the incidence of DLTs leading to a RP2D. The RP2D of the triplet will be the MTD which is defined as the dose level that can be given to 6 subjects such that not more than 1 subject experiences a DLT, For the phase II trial the primary endpoint is objective response rate according to RECIST 1.1 | — |
Secondary
| Measure | Time frame |
|---|---|
| the pharmacokinetic profile of the triple combination, safety and tolerability (frequencies of AEs, dose reductions) and additional anti-tumor efficacy parameters including clinical benefit rate and progression-free survival | — |
Countries
Netherlands
Outcome results
None listed