NCT01191775

A Study of PNT2258 in Patients With Advanced Solid Tumors

A Phase 1 Study of PNT2258 in Patients With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Sierra Oncology LLC - a GSK company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is sponsored by Sierra Oncology, Inc. formerly ProNAi Therapeutics, Inc. 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.

Detailed description

This study 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.

Conditions

• Cancer
• Lymphoma
• Prostate Cancer
• Melanoma

Interventions

Type	Name	Description
DRUG	PNT2258	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.

Timeline

• Start date: 2010-08-01
• Primary completion: 2012-04-01
• Completion: 2012-04-01
• First posted: 2010-08-31
• Last updated: 2023-04-19

Locations

1 site across 1 country: United States