Phase 1/2, Open-label, Dose-escalation Study of IONIS-STAT3Rx, Administered to Patients With Advanced Cancers
NCT ID: NCT01563302
Last Updated: 2018-06-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
64 participants
INTERVENTIONAL
2012-02-27
2016-03-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Group 1
IONIS-STAT3Rx
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Ionis Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Steve Hughes, MD
Role: STUDY_DIRECTOR
Ionis Pharmaceuticals, Inc.
Locations
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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
Countries
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References
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Reilley MJ, McCoon P, Cook C, Lyne P, Kurzrock R, Kim Y, Woessner R, Younes A, Nemunaitis J, Fowler N, Curran M, Liu Q, Zhou T, Schmidt J, Jo M, Lee SJ, Yamashita M, Hughes SG, Fayad L, Piha-Paul S, Nadella MVP, Xiao X, Hsu J, Revenko A, Monia BP, MacLeod AR, Hong DS. STAT3 antisense oligonucleotide AZD9150 in a subset of patients with heavily pretreated lymphoma: results of a phase 1b trial. J Immunother Cancer. 2018 Nov 16;6(1):119. doi: 10.1186/s40425-018-0436-5.
Other Identifiers
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ISIS 481464-CS1
Identifier Type: -
Identifier Source: org_study_id
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