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

• Status: Completed
• Trial end date: 2016-03-23
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ionis Pharmaceuticals, Inc.
• Collaborator: AstraZeneca

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