ISIS 5132 in Treating Patients With Metastatic or Recurrent Ovarian Cancer
Phase II Study of CGP 69846A (ISIS 5132) in Recurrent Epithelial Ovarian Cancer
Sponsor: NCIC Clinical Trials Group
A PHASE2 clinical study on Ovarian Cancer, this trial is completed. The trial is conducted by NCIC Clinical Trials Group and has accumulated 8 data snapshots since 1999. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.
Study Description(click to expand)OBJECTIVES: I. Determine the efficacy of ISIS 5132 by evaluating objective response and duration of response in patients with recurrent ovarian epithelial cancer. II. Determine the tolerability and quantitative toxicity of ISIS 5132 in this patient population.
OUTLINE: This is a multicenter study. Patients receive ISIS 5132 IV continuously for 21 days. Courses are repeated every 28 days. Treatment continues for a maximum of 12 courses in the absence of disease progression or unacceptable toxicity. Patients with documented complete response receive an additional 2 courses. Patients with documented partial response receive an additional 4 courses. Patients are followed at 4 weeks, then every 3 months until disease relapse or progression.
PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study over 12-15 months.
OBJECTIVES: I. Determine the efficacy of ISIS 5132 by evaluating objective response and duration of response in patients with recurrent ovarian epithelial cancer. II. Determine the tolerability and quantitative toxicity of ISIS 5132 in this patient population.
OUTLINE: This is a multicenter study. Patients receive ISIS 5132 IV continuously for 21 days. Courses are repeated every 28 days. Treatment continues for a maximum of 12 courses in the absence of disease progression or unacceptable toxicity. Patients with documented complete response receive an additional 2 courses. Patients with documented partial response receive an additional 4 courses. Patients are followed at 4 weeks, then every 3 months until disease relapse or progression.
PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study over 12-15 months.
Status Flow
Change History
8 versions recorded-
Sep 2025 — Present [monthly]
Completed PHASE2
-
Sep 2024 — Sep 2025 [monthly]
Completed PHASE2
-
Jul 2024 — Sep 2024 [monthly]
Completed PHASE2
-
Jan 2021 — Jul 2024 [monthly]
Completed PHASE2
-
May 2020 — Jan 2021 [monthly]
Completed PHASE2
▶ Show 3 earlier versions
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Apr 2020 — May 2020 [monthly]
Completed PHASE2
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Jun 2018 — Apr 2020 [monthly]
Completed PHASE2
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Jan 2017 — Jun 2018 [monthly]
Completed PHASE2
First recorded
Feb 1999
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- NCIC Clinical Trials Group
For direct contact, visit the study record on ClinicalTrials.gov .
Study Locations
Barrie, Canada , Brampton, Canada , Burnaby, Canada , Charlottetown, Canada , Duluth, United States , Edmonton, Canada , Fleurimont, Canada , Greater Sudbury, Canada , Halifax, Canada , Hamilton, Canada and 33 more locations