This open-label, multicenter, Phase 2 trial, will assess the anti tumor activity, safety and pharmacodynamics, of Panzem® NCD with or without Sunitinib Malate in patients with metastatic renal cell carcinoma progressing on Sunitinib Malate.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
82
NCD suspension, 1500 mg TID daily for 6 week cycles
Sunitinib Malate, highest tolerated dose (patient's current dose), daily oral administration for 4 weeks, with 2 week break in 6 week cycle
Indiana University Cancer Center
Indianapolis, Indiana, United States
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Madison, Wisconsin, United States
To assess the objective response rate of Panzem NCD alone and in combination with Sunitinib Malate
Time frame: Throughout study participation
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