A Phase I Study of a Second Generation Clusterin Antisense Oligonucleotide (OGX-011) in Combination With Docetaxel
- Determine the dose-limiting toxicity and recommended phase II dose of OGX-011 when
administered with docetaxel in patients with metastatic or locally recurrent solid
- Determine the pharmacokinetic profile of this regimen in these patients.
- Assess the effect of OGX-011 on serum clusterin levels and clusterin expression in
peripheral blood mononuclear cells and accessible tumors.
- Assess objective response in patients treated with this regimen.
OUTLINE: This is an open-label, multicenter, dose-escalation study of OGX-011. Patients are
sequentially assigned to 1 of 2 treatment schedules.
- Schedule A: Patients receive OGX-011 IV over 2 hours on days 1, 3, 5, 8, 15, 22, 29,
and 36 of course 1 and once weekly in weeks 1-6 of all subsequent courses. Patients
also receive docetaxel IV over 1 hour once weekly in weeks 1-5. Treatment repeats every
6 weeks for up to 4 courses in the absence of disease progression or unacceptable
- Schedule B: Patients receive OGX-011 IV over 2 hours on days -7, -5, -3, 1, 8, and 15
of course 1 and days 1, 8, and 15 of all subsequent courses. Patients also receive
docetaxel IV over 1 hour on day 1. Treatment repeats every 3 weeks (course 1 is 4 weeks
in duration) for up to 4 courses in the absence of disease progression or unacceptable
Cohorts of 3-6 patients receive escalating doses of OGX-011 (in each schedule) until the
recommended phase II dose (RPTD) is determined. The RPTD is defined as the dose preceding
that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Patients undergo serum collection periodically for pharmacokinetic and pharmacodynamic
After completion of study treatment, patients are followed at 4 weeks and then every 3
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
Kim N. Chi, MD
British Columbia Cancer Agency
United States: Federal Government