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

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

sites

Yale Cancer Center

333 Cedar Street
New Haven, Connecticut 06520

(203) 785-4095