Pharmacodynamic Study With FLT-PET/CT in Patients With Prostate/Other Solid Malignancies Treated With High Dose Axitinib

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01540526
Recruitment Status : Completed
First Posted : February 28, 2012
Last Update Posted : December 15, 2014
Information provided by (Responsible Party):
University of Wisconsin, Madison

February 22, 2012
February 28, 2012
December 15, 2014
March 2012
September 2014   (Final data collection date for primary outcome measure)
Pharmacodynamic change on FLT-PET/CT [ Time Frame: baseline, cycle 1 weeks 2 and 3, pre-cycle 3, cycle 3 weeks 2 and 3 ]
Same as current
Complete list of historical versions of study NCT01540526 on Archive Site
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Pharmacodynamic Study With FLT-PET/CT in Patients With Prostate/Other Solid Malignancies Treated With High Dose Axitinib
Pharmacodynamic Study Using FLT-PET/CT in Patients With Prostate and Other Solid Malignancies Treated With an Interrupted High-dose Axitinib Schedule

The main purpose of this study is to learn more about the safety of an investigational drug, axitinib. An investigational drug is a drug that has not been approved by the Food and Drug Administration (FDA) and is available for research use only. Researchers will also see what changes happen to the tumors while taking the axitinib and after it is stopped (during the scheduled breaks), and what changes in the tumor may be responsible for this growth. This will be done by using a special kind of scan called an 18F-FLT PET/CT. This scan is considered an investigational type of scan and is not used for clinical care. These scans are not approved by the FDA, their use in this study is just for research purposes.

In addition, the investigators want to find out how the drug is processed and distributed in the human body. The investigators will also look at how different types of cancer are affected by axitinib.

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Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Solid Malignancies
  • Metastatic Castrate-resistant Prostate Cancer
Drug: axitinib
7 mg PO BID days 1-14 in 21 day cycles.
  • Experimental: Safety cohort
    6 evaluable patients with RECIST measurable solid malignancies will be enrolled to establish the safety and toxicity of axitinib at 7 mg PO BID days 1-14 in 21 day cycles.
    Intervention: Drug: axitinib
  • Experimental: Pharmacodynamic cohort
    PD cohort A: Up to 6 patients with metastatic castrate-resistant prostate cancer (evidence of soft-tissue metastases amendable to FLT-PET/CT imaging), and PD cohort B: Up to 12 patients with other solid malignancies (evidence of radiographic metastases amendable to FLT-PET/CT imaging) will be enrolled with scans obtained at baseline, peak exposure, and peak withdrawal of axitinib, in cycle#1, with repeat imaging in select patients in PD cohorts A and B at a later cycle of therapy.
    Intervention: Drug: axitinib
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
December 2014
September 2014   (Final data collection date for primary outcome measure)

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 Investigator.
  • 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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University of Wisconsin, Madison
University of Wisconsin, Madison
Principal Investigator: Glenn Liu, M.D. University of Wisconsin, Madison
University of Wisconsin, Madison
December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP