ABOUT THIS STUDY
- 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.
- 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
- 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
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