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Pharmacodynamic Study Using FLT-PET/CT in Patients With Prostate and Other Solid Malignancies Treated With an Interrupted High-dose Axitinib Schedule

Phase 1
18 Years
Open (Enrolling)
Solid Malignancies, Metastatic Castrate-resistant Prostate Cancer

Thank you

Trial Information

Pharmacodynamic Study Using FLT-PET/CT in Patients With Prostate and Other Solid Malignancies Treated With an Interrupted High-dose Axitinib Schedule

Inclusion Criteria:

- Patients must have histologically or cytologically confirmed solid malignancy
(excluding lymphoma) that is metastatic or unresectable and for which no standard
therapy exists.

- Patients must have measurable disease

- Must be >/= 18 years of age

- All patients need to be willing to undergo planned pharmacodynamic assessments,
including serial PET imaging, plasma markers, and pharmacokinetic sampling.

Exclusion Criteria:

- Patients who have had chemotherapy, radiotherapy, experimental therapy or major
surgery within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering
the study or those who have not recovered (to grade -Patients may not be receiving
any other investigational agents.

- Patients with prior anti-VEGF directed therapy may be allowed only if approved by the
PI and greater than 8 weeks since last exposure

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to axitinib

- Patients with poorly controlled hypertension

- Patients who require use of therapeutic doses of coumarin-derivative anticoagulants

- Patients with any condition that impairs their ability to swallow and retain axitinib
tablets are excluded.

- Patients with any of the following conditions are excluded: Serious or nonhealing
wound, ulcer, or bone fracture; History of abdominal fistula, gastrointestinal
perforation, or intra-abdominal abscess within 28 days of treatment; Any history of
cerebrovascular accident (CVA) or transient ischemic attack within 12 months prior to
study entry; History of myocardial infarction, cardiac arrhythmia, stable/unstable
angina, symptomatic congestive heart failure, or coronary/peripheral artery bypass
graft or stenting within 12 months prior to study entry; History of pulmonary
embolism within the past 12 months; Class III or IV heart failure as defined by the
NYHA functional classification system.

- Patients without appropriate lesion on CT scan for FLT-PET/CT imaging

- CYP3A4 inducers/inhibitors medications will be reviewed by the Principal

- Steroid use is not recommended during axitinib treatment

- Patients with a pre-existing thyroid abnormality who are unable to maintain thyroid
function in the normal range with medication are ineligible.

- Patients with known brain metastases should be excluded

- HIV-positive patients on combination antiretroviral therapy are ineligible

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Pharmacodynamic change on FLT-PET/CT

Outcome Time Frame:

baseline, cycle 1 weeks 2 and 3, pre-cycle 3, cycle 3 weeks 2 and 3

Safety Issue:


Principal Investigator

Glenn Liu, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Wisconsin, Madison


United States: Food and Drug Administration

Study ID:




Start Date:

March 2012

Completion Date:

March 2014

Related Keywords:

  • Solid Malignancies
  • Metastatic Castrate-resistant Prostate Cancer
  • Neoplasms
  • Prostatic Neoplasms



University of Wisconsin Carbone Cancer CenterMadison, Wisconsin  53792-5669