A Phase 1 Study of PNT2258 in Patients With Advanced Solid Tumors
This is an open-label, single-arm, Phase 1 dose-escalation study of PNT2258 in patients with
advanced solid tumors for which no standard therapy exists. Patients will receive PNT2258 as
an intravenous infusion once daily for 5 consecutive days (Days 1-5) of every 21-day cycle
(3 weeks). At first, patients will be treated in single patient cohorts following an
accelerated titration design and evaluated for toxicities. After the accelerated portion
ends, patients will be treated in cohorts of at least 3 patients at each dose level and
evaluated for treatment-related toxicities.
Interventional
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the safety of PNT2258 in patients with advanced solid tumors
Safety and tolerability of PNT2258 and the determination of dose-limiting toxicities (DLTs) and the recommended Phase 2 dose
Ongoing
Yes
Anthony W Tolcher, MD, FRCP(C)
Principal Investigator
South Texas Accelerated Research Therapeutics (START)
United States: Food and Drug Administration
P06-10091
NCT01191775
August 2010
April 2012
Name | Location |
---|---|
South Texas Accelerated Research Therapeutics (START) | San Antonio, Texas 78229 |