Clinical evaluation of the underlying mechanisms of targeted therapy related toxicities

Completed

Conditions: Skin and mucosal toxicities of targeted therapies
10027476

Registration Number: NL-OMON37674

Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 120

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 < 1.5 x ULN.
3. Platelet count > 100 x 109/l

Exclusion Criteria

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

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main objective is to explore the biological impact of treatment with<br /><br>targeted agents at the systemic and local tissue level in relation to toxicity.<br /><br><br /><br>This objective will be assessed by studying in normal tissue whether treatment<br /><br>with targeted agents induces significant changes in normal tissue of<br /><br>(1) histopathology, such as differences in the presence of infiltrating immune<br /><br>cells,<br /><br>(2) (phospho)proteomic profiles and<br /><br>(3) kinase activity profiles. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary objectives are<br /><br><br /><br>(1) to perform pharmacokinetics and to study whether serum peptide profiles and<br /><br>systemic circulating immune cells and cytokine profiles in patients during<br /><br>treatment with targeted agents are related to toxicity and<br /><br><br /><br>(2) to identify novel biomarkers predictive of treatment induced toxicity based<br /><br>on pretreatment systemic or local tissue phenotypes. </p><br>