Pilot Study Investigating the Metabolic Activity and Transcriptional Profiling in Vivo in Tumor Biopsies in Melanoma Patients During Treatment With Pazopanib Alone and in Combination With Paclitaxel
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Lead
University of Zurich
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Age ≥ 18 years
Diagnosis of histologically or cytologically confirmed melanoma stage III or IV.
Fresh tumor tissue must be provided for all subjects for biomarker analysis before (within 14 days prior to treatment start) and during (on day 10 of the pazopanib monotherapy and the last day of the treatment with pazopanib, day 70) treatment with investigational product (asservation in RNAlater, for kryo asservation, and for cell cultures)
Assessable metastases (skin or superficial lymph nodes with a minimal diameter 1 cm)
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Adequate organ system function
You may not be if
Prior malignancy.
Central nervous system (CNS) metastases
Corrected QT interval (QTc) \> 480 msecs using Bazett's formula.
History of any one or more of the following cardiovascular conditions within the past 6 months:
* Cardiac angioplasty or stenting;
* Myocardial infarction;
* Unstable angina;
* Coronary artery bypass graft surgery;
* Symptomatic peripheral vascular disease;
* Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA).
Poorly controlled hypertension
History of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months.
Presence of uncontrolled infection
Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding
Evidence of active bleeding or bleeding diathesis
Any ongoing toxicity from prior anti-cancer therapy that is \>Grade 1 and/or that is progressing in severity, except alopecia.
Prior exposure to the study drug pazopanib
Clareo Health | Pilot Study Investigating the Metabolic Activity and Transcriptional Profiling in Vivo in Tumor Biopsies in Melanoma Patients During Treatment With Pazopanib Alone and in Combination With Paclitaxel
