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

Lymphoma Clinical Trial

Official title:

A Phase 1/2 Study of ISIS 481464, an Antisense Oligonucleotide Inhibitor of STAT3, Administered to Patients With Advanced Cancers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01563302
• Other study ID #: ISIS 481464-CS1
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: February 27, 2012
• Est. completion date: March 23, 2016

Study information

• Verified date: June 2018
• Source: Ionis Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: March 23, 2016
• Est. primary completion date: March 23, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Cancers
• DLBCL
• Lymphoma
• Neoplasms

Intervention

Drug:
• 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.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Ionis Pharmaceuticals, Inc.	AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of IONIS-STAT3Rx in patients with Advanced Cancers		Approximately 28 days after last dose of IONIS -STAT3Rx
Primary	Maximum-tolerated dose (MTD) of IONIS-STAT3Rx in patients with Advanced Cancers.	Highest dose level at which no more than 1 out of 6 patients develops a DLT	Approximately 28 Days
Secondary	Clinical activity of IONIS-STAT3Rx	Measured by RECIST in the study population who have measurable disease or relevant disease specific response criteria	Approximately 28 Days after last dose of IONIS-STAT3Rx
Secondary	Pharmacokinetics-Cmax	Maximum observed drug concentration (Cmax)	Approximately 28 days after last dose of IONIS-STAT3Rx
Secondary	STAT3 and other biomarkers	The effect of treatment with IONIS-STAT3Rx on phospho-STAT3 and other biomarkers	Approximately 28 days after last dose of IONIS-STAT3Rx
Secondary	Pharmacokinetics - Tmax	Time taken to reach Cmax	Approximately 28 days after last dose of IONIS-STAT3Rx