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Pharmacodynamic Study of Axitinib in Patients With Advanced Solid Malignancies

Phase 1
18 Years
Open (Enrolling)
Solid Malignancies

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Trial Information

Pharmacodynamic Study of Axitinib in Patients With Advanced Solid Malignancies

Inclusion Criteria:

- Must have histologically or cytologically confirmed solid malignancy (excluding
lymphoma) that is metastatic or unresectable and for which no standard therapy exists
(although all solid malignancies will be enrolled, a subset will be designated for
NSCL cancer will be given due to planned trials in this disease.

- must have measurable disease

- Must be greater than or equal to 18 years old.

- Life expectancy of greater than 12 weeks.

- ECOG performance status less than or equal to 2.

- Patients must have normal organ and marrow function

- Must be willing to undergo planned pharmacodynamic assessments, including serial
PET imaging, plasma markers, and pharmacokinetic sampling.

- Women of childbearing potential and men must use adequate form of birth
(hormonal or barrier method of birth control

- must have ability to understand and willingness to sign a written informed
consent document.

Exclusion Criteria:

- Must not havehad 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 less than or equal to 1 or baseline) from
clinically significant adverse events due to agents administered more than 4 weeks
earlier (alopecia and fatigue excluded).

- Patients may not be receiving any other investigational agents.

- Prior anti-VEGF directed therapy may be allowed only if approved by the PI

- Must not have history of allergic reactions attributed to compounds of similar
chemical or biologic composition to axitinib.

- Must not have poorly controlled hypertension (systolic blood pressure of 140
mmHg or higher or diastolic blood pressure of 90 mmHg or higher)

- Must not require use of therapeutic doses of coumarin-derivative anticoagulants such
as warfarin, although doses of up to 2 mg daily are permitted for prophylaxis of

- Patients with any condition (e.g., gastrointestinal tract disease resulting in
an inability to take oral medication or a requirement for IV alimentation, prior
surgical procedures affecting absorption, or active peptic ulcer disease) that
impairs their ability to swallow and retain axitinib tablets are excluded.

- Patients with any of the following conditions are excluded:

- Serious or non-healing 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 will be

- The eligibility of patients taking medications that are potent inducers or
inhibitors of that enzyme will be determined following a review of their case by
the Principal Investigator.

- Steroid use is not recommended during axitinib treatment unless absolutely

- Patients with a pre-existing thyroid abnormality who are unable to maintain
thyroid function in the normal range with medication are ineligible. Patients
with a history of hypothyroidism are eligible provided they are currently

- Must not have known brain metastases are excluded.

- Must not have uncontrolled intercurrent illness including, but not limited to,
ongoing or active infections or psychiatric illness/social situations that would
limit compliance with study requirements

- Must not be pregnant or breastfeeding.

- Must not be HIV-positive on combination antiretroviral therapy

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine pharmacodynamic change using FLT-PET/CT scans at baseline, during axitinib exposure and washout

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Glenn Liu, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Wisconsin, Madison


United States: Food and Drug Administration

Study ID:




Start Date:

February 2009

Completion Date:

August 2012

Related Keywords:

  • Solid Malignancies
  • Neoplasms



University of Wisconsin Paul P. Carbone Comprehensive Cancer Center Madison, Wisconsin  53792-6164