The purpose of this study is to test the safety of PRLX 93936 and see what kind of effect it has on patients and their cancer. This study will also determine the highest dose of PRLX 93936 that can be given without causing adverse side effects and the dose of PRLX 93936 that should be used in future studies.
This study will assess the safety, pharmacokinetics, and pharmacodynamics of PRLX 93936 administered intravenously over 1 hr daily for 5 days in patients with advanced solid tumors. Patients will be evaluated prior to dosing, during dosing and following dosing, on a 28-day cycle. Tumor response will be evaluated every other cycle. Three patients will be assigned per dose level until the Maximum Tolerated Dose (MTD) is reached or a a Dose-Limited Toxicity (DLT) is encountered. Sequential cohorts of three patients will be treated with escalating doses until the Maximum Tolerated Dose (MTD) is reached.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
37
PRLX 93936 will be administered intravenously over one hour daily for 5 days.
TGen Clinical Research Services at Scottsdale Healthcare
Scottsdale, Arizona, United States
Tower Cancer Research Foundation
Beverly Hills, California, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Clinical laboratory tests
Time frame: Weekly
Vital signs
Time frame: Daily during dosing, then weekly during followup
Electrocardiograms (ECGs)
Time frame: Multiple times during dosing, then weekly during followup
Echocardiograms (ECHO)
Time frame: Baseline and every other cycle
Tumor assessment
Time frame: Baseline and every other cycle
Blood sampling for pharmacokinetics
Time frame: Days 1 and 5 of dosing
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