A Study of PNT2258 in Patients With Advanced Solid Tumors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pronai Therapeutics, Inc
ClinicalTrials.gov Identifier:
NCT01191775
First received: August 27, 2010
Last updated: August 26, 2014
Last verified: August 2014
  Purpose

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 Intervention Phase
Cancer
Lymphoma
Prostate Cancer
Melanoma
Drug: PNT2258
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1 Study of PNT2258 in Patients With Advanced Solid Tumors

Resource links provided by NLM:


Further study details as provided by Pronai Therapeutics, Inc:

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


Secondary Outcome Measures:
  • Pharmacokinetic profile of PNT2258 [ Time Frame: Ongoing ] [ Designated as safety issue: No ]

Enrollment: 22
Study Start Date: August 2010
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

This 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01191775

Locations
United States, Texas
South Texas Accelerated Research Therapeutics (START)
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Pronai Therapeutics, Inc
Investigators
Principal Investigator: Anthony W Tolcher, MD, FRCP(C) South Texas Accelerated Research Therapeutics (START)
  More Information

Additional Information:
No publications provided

Responsible Party: Pronai Therapeutics, Inc
ClinicalTrials.gov Identifier: NCT01191775     History of Changes
Other Study ID Numbers: P06-10091
Study First Received: August 27, 2010
Last Updated: August 26, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pronai Therapeutics, Inc:
Oligonucleotide
DNAi
Oncology
Antineoplastic agent
Lymphoma

Additional relevant MeSH terms:
Prostatic Neoplasms
Lymphoma
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on September 16, 2014