Trial record 1 of 1 for:    NCT01563302
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Phase 1/2, Open-label, Dose-escalation Study of ISIS-STAT3Rx, Administered to Patients With Advanced Cancers

This study is currently recruiting participants.
Verified February 2014 by Isis Pharmaceuticals
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Isis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01563302
First received: February 13, 2012
Last updated: February 12, 2014
Last verified: February 2014
  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: 80
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 patients@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 Recruiting
New Haven, Connecticut, United States, 06510
Principal Investigator: Paul Eder, MD         
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Principal Investigator: Adam M Petrich, MD         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Sub-Investigator: Thomas Witzig, MD         
United States, Missouri
Washington University School of Medicine Recruiting
St. Louis, Missouri, United States, 63110
Principal Investigator: Amanda Cashen, 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
Investigators
Study Director: Mason Yamashita, MD, PhD Isis Pharmaceuticals
  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: February 12, 2014
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 April 21, 2014