This study is being conducted to determine the safety and biologic activity of PX-478, and to allow for observation of any preliminary evidence of antitumor activity in patients with advanced metastatic cancer.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
45
Oral formulation, dose escalation, taken on days 1 to 5 of a 21 day cycle until progression or development of unacceptable toxicity
TGen Clinical Research Services at Scottsdale Healthcare
Scottsdale, Arizona, United States
The University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States
To determine the MTD of PX-478 administered orally on days one to five of a 21 day cycle
Time frame: 21 days
To evaluate the safety profile of PX-478 when administered orally on days one to five of a 21 day cycle
Time frame: 42 days
To evaluate pharmacodynamic measures of the effects of PX 478 on the HIF 1-alpha pathway, and related tumor markers
Time frame: 42 days
To determine the PK profile of PX 478 when administered orally on days one to five of a 21 day cycle
Time frame: 21 days
To evaluate the effects of PX 478 on tumor blood flow and vascular permeability as measured by DCE MRI
Time frame: 21 days
To evaluate the anti-tumor activity of PX 478 in patients with advanced malignancies
Time frame: 42 days
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