A Study of PNT2258 in Patients With Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01191775
Recruitment Status : Completed
First Posted : August 31, 2010
Last Update Posted : January 24, 2017
Information provided by (Responsible Party):
Sierra Oncology, Inc.

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.

Condition or disease Intervention/treatment Phase
Cancer Lymphoma Prostate Cancer Melanoma Drug: PNT2258 Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Study of PNT2258 in Patients With Advanced Solid Tumors
Study Start Date : August 2010
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: PNT2258
PNT2258 is composed of PNT100, a 24-mer oligonucleotide, the active drug substance encapsulated in a liposome.
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.
Other Name: PNT-2258

Primary Outcome Measures :
  1. To determine the safety of PNT2258 in patients with advanced solid tumors [ Time Frame: Ongoing ]
    Safety and tolerability of PNT2258 and the determination of dose-limiting toxicities (DLTs) and the recommended Phase 2 dose

Secondary Outcome Measures :
  1. Pharmacokinetic profile of PNT2258 [ Time Frame: Ongoing ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01191775

United States, Texas
South Texas Accelerated Research Therapeutics (START)
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Sierra Oncology, Inc.
Principal Investigator: Anthony W Tolcher, MD, FRCP(C) South Texas Accelerated Research Therapeutics (START)

Additional Information:
Responsible Party: Sierra Oncology, Inc. Identifier: NCT01191775     History of Changes
Other Study ID Numbers: P06-10091 (PNT2258-01)
First Posted: August 31, 2010    Key Record Dates
Last Update Posted: January 24, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Sierra Oncology, Inc.:
Antineoplastic agent