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

NCT01540526 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2019-11-19

No results posted yet for this study

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.

Conditions

  • Solid Malignancies
  • Metastatic Castrate-resistant Prostate Cancer

Interventions

DRUG

axitinib

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

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • University of Wisconsin, Madison

    lead OTHER

Principal Investigators

  • Glenn Liu, M.D. · University of Wisconsin, Madison

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2014-09-30
Completion
2014-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01540526 on ClinicalTrials.gov