Phase 1/2, Open-label, Dose-escalation Study of ISIS-STAT3Rx, Administered to Patients With Advanced Cancers
This study is currently recruiting participants.
Verified April 2013 by Isis Pharmaceuticals
Sponsor:
Isis Pharmaceuticals
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Isis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01563302
First received: February 13, 2012
Last updated: April 30, 2013
Last verified: April 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Advanced Cancers DLBCL Lymphoma |
Drug: ISIS-STAT3Rx |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 1/2 Study of ISIS 481464, an Antisense Oligonucleotide Inhibitor of STAT3, Administered to Patients With Advanced Cancers |
Resource links provided by NLM:
Further study details as provided by Isis Pharmaceuticals:
Primary Outcome Measures:
- Safety of ISIS-STAT3Rx in patients with Advanced Cancers [ Time Frame: Approximately 28 days after last dose of ISIS -STAT3Rx ] [ Designated as safety issue: No ]
- Maximum-tolerated dose (MTD) of ISIS-STAT3Rx in patients with Advanced Cancers. [ Time Frame: Approximately 28 Days ] [ Designated as safety issue: No ]Highest dose level at which no more than 1 out of 6 patients develops a DLT
Secondary Outcome Measures:
- Clinical activity of ISIS-STAT3Rx [ Time Frame: Approximately 28 Days after last dose of ISIS-STAT3Rx ] [ Designated as safety issue: No ]Measured by RECIST in the study population who have measurable disease or relevant disease specific response criteria
- Pharmacokinetics-Cmax [ Time Frame: Approximately 28 days after last dose of ISIS-STAT3Rx ] [ Designated as safety issue: No ]Maximum observed drug concentration (Cmax)
- STAT3 and other biomarkers [ Time Frame: Approximately 28 days after last dose of ISIS-STAT3Rx ] [ Designated as safety issue: No ]The effect of treatment with ISIS-STAT3Rx on phospho-STAT3 and other biomarkers
- Pharmacokinetics - Tmax [ Time Frame: Approximately 28 days after last dose of ISIS-STAT3Rx ] [ Designated as safety issue: No ]Time taken to reach Cmax
| Estimated Enrollment: | 54 |
| Study Start Date: | February 2012 |
| Estimated Study Completion Date: | July 2014 |
| Estimated Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Group 1
ISIS-STAT3Rx
|
Drug: ISIS-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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01563302
Contacts
| Contact: Isis Pharmaceuticals | 800-679-4747 | info@isisph.com |
Locations
| United States, Arizona | |
| Mayo Clinic Arizona | Recruiting |
| Scottsdale, Arizona, United States, 85259 | |
| Principal Investigator: Mitesh Borad, MD | |
| United States, California | |
| Moores UC San Diego Cancer Center | Recruiting |
| La Jolla, California, United States, 92093 | |
| Principal Investigator: Januario E Castro, MD | |
| United States, Connecticut | |
| Yale Cancer Center | Not yet recruiting |
| New Haven, Connecticut, United States, 06510 | |
| Principal Investigator: Daniel Persky, MD | |
| United States, Illinois | |
| Northwestern University | Not yet recruiting |
| Chicago, Illinois, United States, 60611 | |
| Principal Investigator: Adam M Petrich, MD | |
| United States, Minnesota | |
| Mayo Clinic | Not yet recruiting |
| Rochester, Minnesota, United States, 55905 | |
| Sub-Investigator: Thomas Witzig, MD | |
| United States, Missouri | |
| Washington University School of Medicine | Not yet recruiting |
| St. Louis, Missouri, United States, 63110 | |
| Principal Investigator: Amanda Cashen, MD | |
| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | Not yet recruiting |
| New York, New York, United States, 10065 | |
| Principal Investigator: John Gerecitano, MD | |
| University of Rochester- James P Wilmont Cancer Center | Not yet recruiting |
| Rochester, New York, United States, 14642 | |
| Principal Investigator: Carla Casulo, MD | |
| United States, Texas | |
| Mary Crowley Cancer Research Centers | Recruiting |
| Dallas, Texas, United States, 75201 | |
| Principal Investigator: John Nemunaitis, MD | |
| MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: David S Hong, MD | |
Sponsors and Collaborators
Isis Pharmaceuticals
AstraZeneca
More Information
No publications provided
| Responsible Party: | Isis Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT01563302 History of Changes |
| Other Study ID Numbers: | ISIS 481464-CS1 |
| Study First Received: | February 13, 2012 |
| Last Updated: | April 30, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Isis Pharmaceuticals:
|
Advanced Cancers DLBCL Advanced Lymphoma |
Additional relevant MeSH terms:
|
Lymphoma Neoplasms Neoplasms by Histologic Type Lymphoproliferative Disorders |
Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013