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

Purpose

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	Intervention	Phase
Solid Malignancies Metastatic Castrate-resistant Prostate Cancer	Drug: axitinib	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Single Group Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Nuclear Scans Prostate Cancer

Drug Information available for: Axitinib

U.S. FDA Resources

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:

Pharmacodynamic change on FLT-PET/CT [ Time Frame: baseline, cycle 1 weeks 2 and 3, pre-cycle 3, cycle 3 weeks 2 and 3 ] [ Designated as safety issue: No ]

Estimated Enrollment:	38
Study Start Date:	March 2012
Estimated Study Completion Date:	March 2014
Estimated Primary Completion Date:	March 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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: 6 patients with metastatic castrate-resistant prostate cancer (evidence of soft-tissue metastases amendable to FLT-PET/CT imaging), and PD cohort B: 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.

Arms

Assigned Interventions

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: 6 patients with metastatic castrate-resistant prostate cancer (evidence of soft-tissue metastases amendable to FLT-PET/CT imaging), and PD cohort B: 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01540526

Contacts

Contact: Clinical Trials Office (Cancer Connect)

(800) 622-8922

cancerconnect@uwcarbone.wisc.edu

Locations

United States, Wisconsin
University of Wisconsin Carbone Cancer Center	Recruiting
Madison, Wisconsin, United States, 53792
Principal Investigator: Glenn Liu, M.D.

Sponsors and Collaborators

University of Wisconsin, Madison

Pfizer

Investigators

Principal Investigator:

Glenn Liu, M.D.

University of Wisconsin, Madison

More Information

No publications provided

Responsible Party:	University of Wisconsin, Madison
ClinicalTrials.gov Identifier:	NCT01540526 History of Changes
Other Study ID Numbers:	CO10907
Study First Received:	February 22, 2012
Last Updated:	March 12, 2012
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Neoplasms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms

Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on May 23, 2013