This is a Phase 1 clinical trial examining the safety, pharmacokinetics and pharmacodynamics of escalating doses of the vascular disrupting agent NPI-2358 in patients with refractory solid tumors or lymphoma. The formation of new blood vessels (angiogenesis) is an important component of tumor growth and vascular disrupting agents are intended to target the differences between these tumor blood vessels and the blood vessels in normal tissues. NPI-2358 has also been seen to directly affect tumor cells.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
35
Treatment on Days 1, 8 and 15 in a 28 day cycle
Barbara Ann Karmanos Cancer Institute/Wayne State University
Detroit, Michigan, United States
Institute for Drug Development
San Antonio, Texas, United States
Northwest Medical Specialties
Tacoma, Washington, United States
Safety
Time frame: continuously
Tolerability
Time frame: continuously
Maximum tolerated dose (MTD)
Time frame: continuously
Pharmacokinetics
Time frame: continuously
Pharmacodynamics
Time frame: continuously
Response Evaluation Criteria in Solid Tumors (RECIST)
Time frame: continuously
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