Ignite Creation Date:
2024-05-05 @ 5:30 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00471432
Status:
COMPLETED
Last Update Posted:
2023-08-04
First Post:
2007-05-08
Brief Title:
OGX-011 and Docetaxel in Treating Patients With Metastatic or Locally Recurrent Solid Tumors
Sponsor:
NCIC Clinical Trials Group
Organization:
Canadian Cancer Trials Group
Study Overview
Official Title:
A Phase I Study of a Second Generation Clusterin Antisense Oligonucleotide OGX-011 in Combination With Docetaxel
Status:
COMPLETED
Status Verified Date:
2020-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE OGX-011 may kill tumor cells by blocking some of the proteins that may cause tumor cells to grow Drugs used in chemotherapy such as docetaxel work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving OGX-011 together with docetaxel may kill more tumor cells
PURPOSE This phase I trial is studying the side effects and best dose of OGX-011 when given together with docetaxel in treating patients with metastatic or locally recurrent solid tumors
PURPOSE This phase I trial is studying the side effects and best dose of OGX-011 when given together with docetaxel in treating patients with metastatic or locally recurrent solid tumors
Detailed Description:
OBJECTIVES
Primary
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 tumors
Secondary
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 toxicity
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 toxicity
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 analysis
After completion of study treatment patients are followed at 4 weeks and then every 3 months thereafter
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study
Primary
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 tumors
Secondary
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 toxicity
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 toxicity
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 analysis
After completion of study treatment patients are followed at 4 weeks and then every 3 months thereafter
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CAN-NCIC-IND154 | OTHER | None | None |
| ONCOGENEX-OGX-01-02 | OTHER | None | None |
| CDR0000547039 | OTHER | PDQ | None |