Pharmacodynamic Study With FLT-PET/CT in Patients With Prostate/Other Solid Malignancies Treated With High Dose Axitinib
NCT01540526
ABOUT THIS STUDY
FOR MORE INFORMATION
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- 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.
- 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
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Descriptive Information | ||||
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Brief Title ICMJE | Pharmacodynamic Study With FLT-PET/CT in Patients With Prostate/Other Solid Malignancies Treated With High Dose Axitinib | |||
Official Title ICMJE | Pharmacodynamic Study Using FLT-PET/CT in Patients With Prostate and Other Solid Malignancies Treated With an Interrupted High-dose Axitinib Schedule | |||
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. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE |
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Intervention ICMJE | Drug: axitinib
7 mg PO BID days 1-14 in 21 day cycles. | |||
Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 24 | |||
Original Estimated Enrollment ICMJE | 38 | |||
Actual Study Completion Date ICMJE | December 2014 | |||
Actual Primary Completion Date | September 2014 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01540526 | |||
Other Study ID Numbers ICMJE | 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 ) | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | University of Wisconsin, Madison | |||
Study Sponsor ICMJE | University of Wisconsin, Madison | |||
Collaborators ICMJE | Pfizer | |||
Investigators ICMJE |
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PRS Account | University of Wisconsin, Madison | |||
Verification Date | December 2014 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |