Clinical trial NCT01563302: Phase 1/2, Open-label, Dose-escalation Study of IONIS-STAT3Rx, Administered to Patients With Advanced Cancers
Official title: A Phase 1/2 Study of ISIS 481464, an Antisense Oligonucleotide Inhibitor of STAT3, Administered to Patients With Advanced Cancers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Advanced Cancers
DLBCL
Lymphoma
Keywords: Advanced Cancers
DLBCL
Advanced Lymphoma
Lead sponsor: Ionis Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
Collaborators: name: AstraZeneca
First posted: 2012-03-26
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Safety of IONIS-STAT3Rx in patients with Advanced Cancers
timeFrame: Approximately 28 days after last dose of IONIS -STAT3Rx
measure: Maximum-tolerated dose (MTD) of IONIS-STAT3Rx in patients with Advanced Cancers.
timeFrame: Approximately 28 Days
Secondary outcomes:
measure: Clinical activity of IONIS-STAT3Rx
timeFrame: Approximately 28 Days after last dose of IONIS-STAT3Rx
measure: Pharmacokinetics-Cmax
timeFrame: Approximately 28 days after last dose of IONIS-STAT3Rx
measure: STAT3 and other biomarkers
timeFrame: Approximately 28 days after last dose of IONIS-STAT3Rx
measure: Pharmacokinetics - Tmax
timeFrame: Approximately 28 days after last dose of IONIS-STAT3Rx
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic Arizona
state: Arizona
city: La Jolla
country: United States
facility: Moores UC San Diego Cancer Center
state: California
city: New Haven
country: United States
facility: Yale Cancer Center
state: Connecticut
city: Atlanta
country: United States
facility: Blood and Marrow Transplant Group of Georgia at Northside Hospital
state: Georgia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Dallas
country: United States
facility: Mary Crowley Cancer Research Centers
state: Texas
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: Ionis Pharmaceuticals, Inc.
name: Steve Hughes, MD
role: STUDY_DIRECTOR
References:
citation: 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.