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Completed

NCT Number: NCT01563302

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

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.

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Key information

Conditions

Advanced Cancers DLBCL Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Mayo Clinic Arizona, Scottsdale, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IONIS-STAT3Rx

Drug

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

Primary outcomes

  1. Safety of IONIS-STAT3Rx in patients with Advanced Cancers

    Time frame: Approximately 28 days after last dose of IONIS -STAT3Rx

  2. Maximum-tolerated dose (MTD) of IONIS-STAT3Rx in patients with Advanced Cancers.

    Time frame: Approximately 28 Days

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

Secondary outcomes

  1. Clinical activity of IONIS-STAT3Rx

    Time frame: 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

    Time frame: Approximately 28 days after last dose of IONIS-STAT3Rx

    Maximum observed drug concentration (Cmax)

  3. STAT3 and other biomarkers

    Time frame: 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

    Time frame: Approximately 28 days after last dose of IONIS-STAT3Rx

    Time taken to reach Cmax

Sponsors and collaborators

Lead sponsor

Ionis Pharmaceuticals, Inc.

Industry

Collaborators

  • AstraZeneca

Registry information

Official study title

A Phase 1/2 Study of ISIS 481464, an Antisense Oligonucleotide Inhibitor of STAT3, Administered to Patients With Advanced Cancers

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Mar 26, 2012
Registry last updated
Jun 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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