Expired Study
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San Antonio, Texas 78229


Purpose:

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.


Study summary:

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.


Criteria:

Inclusion Criteria: - 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. Exclusion Criteria: - 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.


Study is Available At:


Original ID:

P06-10091 (PNT2258-01)


NCT ID:

NCT01191775


Secondary ID:


Study Acronym:


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


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Sierra Oncology, Inc.


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

22


Enrollment Type:

Actual


Overall Contact Information

Official Name:Anthony W Tolcher, MD, FRCP(C)
Principal Investigator
South Texas Accelerated Research Therapeutics (START)

Study Dates

Start Date:August 2010
Completion Date:April 2012
Completion Type:Actual
Primary Completion Date:April 2012
Primary Completion Type:Actual
Verification Date:January 2017
Last Changed Date:January 20, 2017
First Received Date:August 27, 2010

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Pharmacokinetic profile of PNT2258
Time Frame:Ongoing
Safety Issues:False
Outcome Type:Primary Outcome
Measure:To determine the safety of PNT2258 in patients with advanced solid tumors
Time Frame:Ongoing
Safety Issues:False
Description:Safety and tolerability of PNT2258 and the determination of dose-limiting toxicities (DLTs) and the recommended Phase 2 dose

Study Interventions

Intervention Type:Drug
Name:PNT2258
Description: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.
Arm Name:PNT2258
Other Name:PNT-2258

Study Arms

Study Arm Type:Experimental
Arm Name:PNT2258
Description:PNT2258 is composed of PNT100, a 24-mer oligonucleotide, the active drug substance encapsulated in a liposome.

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Sierra Oncology, Inc.

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation: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.
PMID:24297683

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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