A Study of PNT2258 in Patients With Advanced Solid Tumors

NCT01191775 | Completed Phase 1

• 1 other identifier: P06-10091 (PNT2258-01)
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; Lymphoma; Prostate Cancer; Melanoma

Keywords

Oligonucleotide; DNAi; Oncology; Antineoplastic agent; Lymphoma; PNT2258

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Pharmacokinetic profile of PNT2258

  Ongoing

Study Arms (1)

PNT2258

EXPERIMENTAL

PNT2258 is composed of PNT100, a 24-mer oligonucleotide, the active drug substance encapsulated in a liposome.

Drug: PNT2258

Interventions

PNT2258 DRUG

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.

Also known as: PNT-2258

PNT2258

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed, malignant solid tumor (measurable or non-measurable disease) and cannot be a candidate for known regimens or protocol treatments of higher efficacy or priority.
• Recovered to Grade 1 from all acute toxicities of prior therapies, except for residual toxicities, such as alopecia, which do not pose an ongoing medical risk.
• ECOG performance status of 0, 1, or 2.
• At least 18 years of age.
• Patients must have normal organ and marrow function as defined by:
• Absolute neutrophil count 1,500/µL
• Platelets 100,000/µL
• Total bilirubin within normal institutional limits
• AST(SGOT)/ALT(SGPT) 2.5 x institutional upper limit of normal (ULN) or 5.0 x ULN in patients with liver metastases
• Serum creatinine 1.5 x ULN or measured creatinine clearance of 60 mL/min/1.73 m2.
• Negative serum pregnancy test at the time of enrollment for women of child-bearing potential. For men and women of child-producing potential, use of effective contraceptive methods is required during the study.
• Ability to understand the requirements of the study. Must provide written informed consent and authorization of use and disclosure of protected health information. Must agree to abide by the study restrictions and to return for the required assessments.

You may not qualify if:

• Received previous anticancer chemotherapy, immunotherapy, radiotherapy or any other investigational therapy in the 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to study entry.
• Receiving any other investigational agents.
• Known brain metastases with the exception of patients with a history of treated brain metastases who are stable for at least 3 months off glucocorticoids and seizure medications.
• Prolongation of QT/QTc interval \> 450 milliseconds (ms).
• Known HIV, HBV, or HCV infection.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to PNT2258.
• History of allergic reaction to egg or chicken antigens.
• Pregnant or nursing women.
• Uncontrolled intercurrent illness including, but not limited to ongoing or serious active infection, symptomatic congestive heart failure, unstable angina pectoris, serious cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Sponsors & Collaborators

• Sierra Oncology LLC - a GSK company: lead

Study Sites (1)

South Texas Accelerated Research Therapeutics (START)

San Antonio, Texas, 78229, United States

Location

Related Publications (1)

• Tolcher AW, Rodrigueza WV, Rasco DW, Patnaik A, Papadopoulos KP, Amaya A, Moore TD, Gaylor SK, Bisgaier CL, Sooch MP, Woolliscroft MJ, Messmann RA. A phase 1 study of the BCL2-targeted deoxyribonucleic acid inhibitor (DNAi) PNT2258 in patients with advanced solid tumors. Cancer Chemother Pharmacol. 2014 Feb;73(2):363-71. doi: 10.1007/s00280-013-2361-0. Epub 2013 Dec 3.

  PMID: 24297683 BACKGROUND

Related Links

• Sponsor's Web Site

MeSH Terms

Conditions

Neoplasms; Lymphoma; Prostatic Neoplasms; Melanoma

Interventions

PNT100

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Anthony W Tolcher, MD, FRCP(C)

  South Texas Accelerated Research Therapeutics (START)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2010
• First Posted: August 31, 2010
• Study Start: August 1, 2010
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: April 19, 2023

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)