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


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Advanced Cancers, DLBCL, Lymphoma

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety of ISIS-STAT3Rx in patients with Advanced Cancers

Outcome Time Frame:

Approximately 28 days after last dose of ISIS -STAT3Rx

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

ISIS 481464-CS1

NCT ID:

NCT01563302

Start Date:

February 2012

Completion Date:

July 2014

Related Keywords:

  • Advanced Cancers
  • DLBCL
  • Lymphoma
  • Advanced Cancers
  • DLBCL
  • Advanced Lymphoma
  • Lymphoma
  • Neoplasms

Name

Location

MD Anderson Cancer CenterHouston, Texas  77030-4096
Mayo ClinicRochester, Minnesota  55905
Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Washington University School of MedicineSaint Louis, Missouri  63110
Yale Cancer CenterNew Haven, Connecticut  06520-8028
Northwestern UniversityChicago, Illinois  60611
Mayo Clinic ArizonaScottsdale, Arizona  85259
Mary Crowley Cancer Research CentersDallas, Texas  75201
Moores UC San Diego Cancer CenterLa Jolla, California  92093