Phase I Study of Axitinib and Temsirolimus in Solid Tumors

Inclusion Criteria

Inclusion Criteria/Exclusion Criteria:

- Patients must have histologically confirmed non-hematologic malignancy for which
standard curative or palliative measures do not exist or are no longer effective.

- Patients with hepatocellular carcinoma do not need histologic confirmation of
malignancy if the following criteria were met at diagnosis:

- Liver lesions 1 - 2 cm with arterial enhancement and washout in venous phase of
CT/MRI

- Liver lesions ≥ 2 cm with arterial enhancement and washout in venous phase of
CT/MRI or serum alpha-feto protein ≥ 200 ng/mL

- ECOG Performance Status 0 or 1

- Marrow and Organ function requirements:

- Absolute Neutrophil Count ≥ 1000/mm3

- Platelets ≥ 75,000/mm3

- Hemoglobin ≥ 9.0 g/dL

- Total bilirubin ≤ 1.5 x upper limit of normal (ULN)

- Alkaline phosphatase ≤ 2.5 x ULN (≤ 5 x ULN if liver metastasis present)

- AST and ALT ≤2.5 x ULN (≤ 5 x ULN if liver metastasis present or patient has
diagnosis of hepatocellular carcinoma or cholangiocarcinoma)

- Creatinine ≤ 1.5 x ULN

- Urinalysis ≤ 1+ protein on dipstick or Urine creatinine:protein ratio < 1.0
If urine protein >1 1+ or urine creatinine:protein ratio > 1, then 24 hour urine
protein should be obtained and the level should be < 1000mg for patient
enrollment.

- Fasting serum cholesterol ≤ 350mg/dL

- Triglycerides ≤1.5 x ULN

- Life Expectancy ≥ 12 weeks

- At least 2 weeks since end of prior systemic treatment (4 weeks for bevacizumab
containing regimens), radiotherapy, or surgical procedure with resolution of all
treatment related toxicity.

- No evidence of uncontrolled hypertension as evidenced by 2 readings of < 140/90
measured 1 hour apart. Prexisting hypertension controlled with medication is
allowed.

- No gastrointestinal disorders including active peptic ulcer disease (within 6
months); active bleeding unrelated to malignancy; or melena, hematemesis, or
hematochezia in the past 3 months without endoscopically-proven resolution

- No cardiovascular history within 12 months including: MI, uncontrolled angina, CABG,
or symptomatic CHF

- Women of child bearing potential must have negative pregnancy test.

- Willingness and ability to comply with scheduled visits.

- Able to ingest oral medications

- No concurrent use or anticipated need for potent CYP3A4 inhibitors or CYP3A4 or
CYP1A2 inducers