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



Status:Completed
Conditions:Cancer, Cancer, Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:6/27/2018
Start Date:February 27, 2012
End Date:March 23, 2016

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A Phase 1/2 Study of ISIS 481464, an Antisense Oligonucleotide Inhibitor of STAT3, 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.


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
We found this trial at
9
sites
La Jolla, California 92093
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Atlanta, GA
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303 East Superior Street
Chicago, Illinois 60611
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Chicago, IL
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Dallas, TX
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Houston, Texas 77030
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Houston, TX
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333 Cedar Street
New Haven, Connecticut 06520
(203) 785-4095
Yale Cancer Center Yale Cancer Center combines a tradition of innovative cancer treatment and quality...
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New Haven, CT
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Rochester, Minnesota 55905
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Rochester, MN
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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Saint Louis, MO
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13400 E. Shea Blvd.
Scottsdale, Arizona 85259
480-301-8000
Mayo Clinic Arizona Mayo Clinic in Arizona provides medical care for thousands of people from...
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mi
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Scottsdale, AZ
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