COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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 : November 19, 2019
Information provided by (Responsible Party):
University of Wisconsin, Madison

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Solid Malignancies Metastatic Castrate-resistant Prostate Cancer Drug: axitinib Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacodynamic Study Using FLT-PET/CT in Patients With Prostate and Other Solid Malignancies Treated With an Interrupted High-dose Axitinib Schedule
Study Start Date : March 2012
Actual Primary Completion Date : September 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Axitinib

Arm Intervention/treatment
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.
Drug: axitinib
7 mg PO BID days 1-14 in 21 day cycles.

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.
Drug: axitinib
7 mg PO BID days 1-14 in 21 day cycles.

Primary Outcome Measures :
  1. Pharmacodynamic change on FLT-PET/CT [ Time Frame: baseline, cycle 1 weeks 2 and 3, pre-cycle 3, cycle 3 weeks 2 and 3 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01540526

Layout table for location information
United States, Wisconsin
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Layout table for investigator information
Principal Investigator: Glenn Liu, M.D. University of Wisconsin, Madison
Additional Information:
Layout table for additonal information
Responsible Party: University of Wisconsin, Madison Identifier: NCT01540526    
Other Study ID Numbers: CO10907
2011-0575 ( Other Identifier: Institutional Review Board )
NCI-2012-00142 ( Registry Identifier: NCI Trial ID )
A534260 ( Other Identifier: UW Madison )
SMPH\MEDICINE\HEM-ONC ( Other Identifier: UW Madison )
First Posted: February 28, 2012    Key Record Dates
Last Update Posted: November 19, 2019
Last Verified: December 2014
Additional relevant MeSH terms:
Layout table for MeSH terms
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action