A Phase I, Multi-center, Open-Label, Dose-Escalation, Safety, Pharmacodynamic and Pharmacokinetic Study of PRLX 93936 Administered Intravenously Daily for Five Days Followed by a 23-Day Rest Period in Patients With Advanced Solid Tumors
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.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Clinical laboratory tests
Weekly
Yes
Daniel Von Hoff, M.D.
Principal Investigator
TGen Clinical Research Services at Scottsdale Healthcare
United States: Food and Drug Administration
PRLX93936-0001
NCT00528047
August 2007
November 2011
Name | Location |
---|---|
Tower Cancer Research Foundation | Beverly Hills, California 90211 |
Dana Farber Cancer Institute | Boston, Massachusetts 02115 |
TGen Clinical Research Services at Scottsdale Healthcare | Scottsdale, Arizona 85258 |