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Spots Global Cancer Trial Database for A Study of PNT2258 in Patients With Advanced Solid Tumors

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Trial Identification

Brief Title: A Study of PNT2258 in Patients With Advanced Solid Tumors

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

Study ID: NCT01191775

Interventions

PNT2258

Study Description

Brief 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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

South Texas Accelerated Research Therapeutics (START), San Antonio, Texas, United States

Contact Details

Name: Anthony W Tolcher, MD, FRCP(C)

Affiliation: South Texas Accelerated Research Therapeutics (START)

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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