A Study of PNT2258 in Patients With Advanced Solid Tumors
The purpose of this research study is to evaluate the safety of the investigational drug PNT2258 in patients with advance tumors and see how it acts in the body.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 1 Study of PNT2258 in Patients With Advanced Solid Tumors|
- To determine the safety of PNT2258 in patients with advanced solid tumors [ Time Frame: Ongoing ] [ Designated as safety issue: Yes ]Safety and tolerability of PNT2258 and the determination of dose-limiting toxicities (DLTs) and the recommended Phase 2 dose
- Pharmacokinetic profile of PNT2258 [ Time Frame: Ongoing ] [ Designated as safety issue: No ]
|Study Start Date:||August 2010|
|Study Completion Date:||April 2012|
|Primary Completion Date:||April 2012 (Final data collection date for primary outcome measure)|
PNT2258 is composed of PNT100, a 24-mer oligonucleotide, the active drug substance encapsulated in a liposome.
Patients will receive PNT2258 as an intravenous infusion once daily for 5 consecutive days (Days 1-5) of every 21-day cycle (3 weeks). The treatment cycle repeats every 3 weeks for up to 6 cycles in the absence of disease progression, unacceptable toxicity, or patient withdrawal from the study.
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.
|United States, Texas|
|South Texas Accelerated Research Therapeutics (START)|
|San Antonio, Texas, United States, 78229|
|Principal Investigator:||Anthony W Tolcher, MD, FRCP(C)||South Texas Accelerated Research Therapeutics (START)|