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

Completed · Phase 1/Phase 2

Conditions studied: Advanced Cancers, DLBCL, Lymphoma

In brief

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.

Key facts

Study ID

NCT01563302

Run by

Ionis Pharmaceuticals, Inc.

People needed

64

Starts

2012-02-27

Expected to finish

2016-03-23

Last updated by the study team

2018-06-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Mayo Clinic Arizona — Scottsdale, Arizona, United States
• Moores UC San Diego Cancer Center — La Jolla, California, United States
• Yale Cancer Center — New Haven, Connecticut, United States
• Blood and Marrow Transplant Group of Georgia at Northside Hospital — Atlanta, Georgia, United States
• Northwestern University — Chicago, Illinois, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Mary Crowley Cancer Research Centers — Dallas, Texas, United States
• MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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