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| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | IONIS-STAT3Rx |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IONIS-STAT3Rx | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety of IONIS-STAT3Rx in patients with Advanced Cancers | Approximately 28 days after last dose of IONIS -STAT3Rx | |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Pharmacokinetics-Cmax |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steve Hughes, MD | Ionis Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Arizona | Scottsdale | Arizona | 85259 | United States | ||
| Moores UC San Diego Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30446007 | Derived | 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. |
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|
Maximum observed drug concentration (Cmax)
| Approximately 28 days after last dose of IONIS-STAT3Rx |
| 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 |
| Pharmacokinetics - Tmax | Time taken to reach Cmax | Approximately 28 days after last dose of IONIS-STAT3Rx |
| La Jolla |
| California |
| 92093 |
| United States |
| Yale Cancer Center | New Haven | Connecticut | 06510 | United States |
| Blood and Marrow Transplant Group of Georgia at Northside Hospital | Atlanta | Georgia | 30342 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Mary Crowley Cancer Research Centers | Dallas | Texas | 75201 | United States |
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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