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Phase I Study of Axitinib and Temsirolimus in Solid Tumors

Phase 1
18 Years
Open (Enrolling)

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Trial Information

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

- 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

- 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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Changes in the largest diameter (unidimensional measurement) of the tumor lesions and the shortest diameter in the case of malignant lymph nodes are used in the RECIST(Response Evaluation Criteria in Solid Tumors)criteria for evaluation.

Outcome Description:

Complete Response:Disappearance of all target lesions.Any pathological lymph nodes must have reduction in short axis to <10 mm. Partial Response:At least a 30% decrease in the sum of the diameters of target lesions Progressive Disease:At least a 20% increase in the sum of the diameters of target lesions.Note: the appearance of one or more new lesions is also considered progressions). Stable Disease:Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.

Outcome Time Frame:

Approximately re-evaluated every 8 weeks

Safety Issue:


Principal Investigator

John Kauh, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Emory University Winship Cancer Institute


United States: Food and Drug Administration

Study ID:




Start Date:

October 2011

Completion Date:

October 2014

Related Keywords:

  • Cancer
  • Cancer



Emory University Winship Cancer Institute Atlanta, Georgia  30322