Clinical Evaluation of the Underlying Mechanisms of Targeted Therapy Related Toxicities

Single center, non-randomized, interventional pilot study with feasibility analysis after enrollment of 20 patients. Adult patients with advanced solid tumors, for whom standard palliative treatment with targeted agents as monotherapy is indicated, including antiangiogenic tyrosine kinase inhibitors, EGFR inhibitors, mTOR inhibitors, BRAF inhibitors and ipilimumab.After feasibility analysis in the first twenty patients, twenty more patients will be included in each of the five drug cohorts. Biopsies will be performed to determine possible immunohistochemical and histopathological changes in normal tissue, possible immunomodulatory changes as expressed by Tcell phenotyping and cytokine profiling and to compare tissue (phospho) proteomic and kinase activity profiles before and during therapy and also at the development of toxicity.The main objective of this pilot study is to determine the biological impact of treatment with targeted agents at the systemic and local tissue level in relation to toxicity.

Sex

All

Minimum age

18 Years

Inclusion Criteria:

1. Patients that will start palliative treatment with TKIs, mTOR inhibitors, ipilimumab, vemurafenib or EGFR inhibitors and therefore fulfill according to their attending physician all the usual criteria for receiving standard targeted therapy as monotherapy.
2. PT-INR/PTT \< 1.5 x ULN.
3. Platelet count \>/= 100 x 109/l

Exclusion Criteria:

1. Concomitant use of anticoagulants
2. Previous colonic surgery in the last 3 months
3. History of inflammatory bowel disease, or other active gastrointestinal infection