Skin and mucosal toxicities of targeted therapies
Conditions
Interventions
None listed
Sponsors
Vrije Universiteit Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Patients that will start palliative treatment with TKIs, mTOR inhibitors, ipilimumab, vemurafenib or anti-EGFR antibodies and therefore fulfill according to their attending physician all the usual criteria for receiving standard targeted therapy as monotherapy. 2. PT-INR/PTT 100 x 109/l
Exclusion criteria
Exclusion criteria: * Concomitant use of anticoagulants * Previous colonic surgery in the last 3 months * History of inflammatory bowel disease, or other active gastrointestinal infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main objective is to explore the biological impact of treatment with targeted agents at the systemic and local tissue level in relation to toxicity. This objective will be assessed by studying in normal tissue whether treatment with targeted agents induces significant changes in normal tissue of (1) histopathology, such as differences in the presence of infiltrating immune cells, (2) (phospho)proteomic profiles and (3) kinase activity profiles. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objectives are (1) to perform pharmacokinetics and to study whether serum peptide profiles and systemic circulating immune cells and cytokine profiles in patients during treatment with targeted agents are related to toxicity and (2) to identify novel biomarkers predictive of treatment induced toxicity based on pretreatment systemic or local tissue phenotypes. | — |
Countries
Netherlands
Outcome results
None listed