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Clinical Trials/NL-OMON37356
NL-OMON37356
Completed
Not Applicable

Therapeutic Drug Monitoring to Individualize the Dosing of pazopanib: a Randomized Pharmacokinetic Feasibility Study - TIP-study

eids Universitair Medisch Centrum0 sites13 target enrollmentTBD

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
advanced tumors for which no treatment options are available
Sponsor
eids Universitair Medisch Centrum
Enrollment
13
Status
Completed
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

Investigators

Eligibility Criteria

Inclusion Criteria

  • \- Age \* 18 years
  • \- Eastern Cooperative Oncology Group (ECOG) performance status of 0\-2
  • \- No radio\-, chemo\- or tumorspecific targeted therapy within the last 4 weeks prior to study entry
  • \- Adequate organ system function
  • \- Patients or partners of patients with childbearing potential should practice adequate contraception (double barrier protection).
  • \- Patient who are lactating should discontinue nursing prior to the first dose and should refrain from nursing throughout the treatment period and for 14 days following the last dose of study drug.

Exclusion Criteria

  • \- Current treatment in another therapeutic clinical trial
  • \- History or clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis, except for individuals who have previously\-treated CNS metastases, are asymptomatic, and have had no requirement for steroids or anti\-seizure medication for 6 months prior to first dose of study drug.
  • \- Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding
  • \- Clinically significant gastrointestinal abnormalities that may affect absorption of investigational product
  • \- Presence of uncontrolled infection.
  • \- Corrected QT interval (QTc) \> 480 msecs using Bazett\*s formula (QTc \= QT/\*RR)
  • \- History of any one or more of the following cardiovascular conditions within the past 6 months:
  • \* Cardiac angioplasty or stenting
  • \* Myocardial infarction
  • \* Unstable angina

Outcomes

Primary Outcomes

Not specified

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