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Phase 1/2, Open-label, Dose-escalation Study of IONIS-STAT3Rx, Administered to Patients With Advanced Cancers

Sponsor
Ionis Pharmaceuticals, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01563302
Collaborator
AstraZeneca (Industry)
64
Enrollment
9
Locations
1
Arm
48.8
Actual Duration (Months)
7.1
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a Phase 1/2, open-label, dose-escalation, dose-expansion study for the treatment of patients with advanced cancers. Eligible patients with DLBCL or other advanced lymphomas will be enrolled into the dose-expansion cohort.

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
64 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1/2 Study of ISIS 481464, an Antisense Oligonucleotide Inhibitor of STAT3, Administered to Patients With Advanced Cancers
Actual Study Start Date :
Feb 27, 2012
Actual Primary Completion Date :
Mar 23, 2016
Actual Study Completion Date :
Mar 23, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group 1

IONIS-STAT3Rx

Drug: IONIS-STAT3Rx
Three-hour IV infusions on Cycle 0 Days 1, 3, 5, and weekly three-hour IV infusions in Cycles 1 and beyond, on Days 1, 8, and 15 of each cycle.
Other Names:
  • ISIS 481464

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Safety of IONIS-STAT3Rx in patients with Advanced Cancers [Approximately 28 days after last dose of IONIS -STAT3Rx]

    2. Maximum-tolerated dose (MTD) of IONIS-STAT3Rx in patients with Advanced Cancers. [Approximately 28 Days]

      Highest dose level at which no more than 1 out of 6 patients develops a DLT

    Secondary Outcome Measures

    1. Clinical activity of IONIS-STAT3Rx [Approximately 28 Days after last dose of IONIS-STAT3Rx]

      Measured by RECIST in the study population who have measurable disease or relevant disease specific response criteria

    2. Pharmacokinetics-Cmax [Approximately 28 days after last dose of IONIS-STAT3Rx]

      Maximum observed drug concentration (Cmax)

    3. STAT3 and other biomarkers [Approximately 28 days after last dose of IONIS-STAT3Rx]

      The effect of treatment with IONIS-STAT3Rx on phospho-STAT3 and other biomarkers

    4. Pharmacokinetics - Tmax [Approximately 28 days after last dose of IONIS-STAT3Rx]

      Time taken to reach Cmax

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Aged 18 years or older

    • Tumors that are relapsed or refractory to at least 1 prior anti-cancer systemic therapy and for which no standard therapy exists

    • Expansion cohort only: Advanced lymphoma confirmed by histopathology

    • Measurable or evaluable disease according to RECIST for solid tumors or according to IWRC for NHL tumors

    • ECOG Performance Status less than or equal to 2

    • Life expectancy greater than 12 weeks in the opinion of the Investigator

    Exclusion Criteria:

    • Any active or uncontrolled infection

    • NYHA Grade II or greater congestive heart failure

    • History of myocardial infarction within 6 months prior to screening

    • Prior radiation therapy, chemotherapy, hormonal therapy, or immunotherapy within 4 weeks prior to screening or 5 half-lives of the therapy, whichever is shorter

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic Arizona Scottsdale Arizona United States 85259
    2 Moores UC San Diego Cancer Center La Jolla California United States 92093
    3 Yale Cancer Center New Haven Connecticut United States 06510
    4 Blood and Marrow Transplant Group of Georgia at Northside Hospital Atlanta Georgia United States 30342
    5 Northwestern University Chicago Illinois United States 60611
    6 Mayo Clinic Rochester Minnesota United States 55905
    7 Washington University School of Medicine Saint Louis Missouri United States 63110
    8 Mary Crowley Cancer Research Centers Dallas Texas United States 75201
    9 MD Anderson Cancer Center Houston Texas United States 77030

    Sponsors and Collaborators

    • Ionis Pharmaceuticals, Inc.
    • AstraZeneca

    Investigators

    • Study Director: Steve Hughes, MD, Ionis Pharmaceuticals, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ionis Pharmaceuticals, Inc.
    ClinicalTrials.gov Identifier:
    NCT01563302
    Other Study ID Numbers:
    • ISIS 481464-CS1
    First Posted:
    Mar 26, 2012
    Last Update Posted:
    Jun 25, 2018
    Last Verified:
    Jun 1, 2018
    Keywords provided by Ionis Pharmaceuticals, Inc.
    Advanced Cancers
    DLBCL
    Advanced Lymphoma
    Additional relevant MeSH terms:
    Neoplasms

    Study Results

    No Results Posted as of Jun 25, 2018