Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00028548
Status:
COMPLETED
Last Update Posted:
2014-04-25
First Post:
2002-01-04
Brief Title:
XK469 in Treating Patients With Advanced Solid Tumors
Sponsor:
Barbara Ann Karmanos Cancer Institute
Organization:
Barbara Ann Karmanos Cancer Institute
Study Overview
Official Title:
Phase I Study of R-XK469 NSC 698215 Given Daily Days 1-5 Repeated Every Three Weeks in Patients With Advanced Malignancies
Status:
COMPLETED
Status Verified Date:
2014-04
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 Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
PURPOSE Phase I trial to study the effectiveness of XK469 in treating patients who have advanced solid tumors
PURPOSE Phase I trial to study the effectiveness of XK469 in treating patients who have advanced solid tumors
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose dose-limiting toxicity and recommended phase II dose of XK469 in patients with advanced solid tumors
Determine the safety of this drug in these patients
Determine the pharmacokinetics of this drug in these patients
Determine preliminarily any anti-tumor activity of this drug in these patients
Determine the drug metabolism drug interaction potential molecular and cellular predictors of efficacy and toxicity and clinical confirmation of molecular responses in patients treated with this drug
OUTLINE This is a dose-escalation study
Patients receive XK469 IV over 20 minutes on days 1-5 Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of XK469 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of the first 6 patients experience dose-limiting toxicity
Once the MTD is determined up to 15 patients are treated at that dose Patients in the expanded MTD cohort also receive oral NovaSoy soybean extract twice daily for the study duration
Patients are followed every 4 weeks
PROJECTED ACCRUAL Approximately 25-40 patients will be accrued for this study within 12-15 months
Determine the maximum tolerated dose dose-limiting toxicity and recommended phase II dose of XK469 in patients with advanced solid tumors
Determine the safety of this drug in these patients
Determine the pharmacokinetics of this drug in these patients
Determine preliminarily any anti-tumor activity of this drug in these patients
Determine the drug metabolism drug interaction potential molecular and cellular predictors of efficacy and toxicity and clinical confirmation of molecular responses in patients treated with this drug
OUTLINE This is a dose-escalation study
Patients receive XK469 IV over 20 minutes on days 1-5 Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of XK469 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of the first 6 patients experience dose-limiting toxicity
Once the MTD is determined up to 15 patients are treated at that dose Patients in the expanded MTD cohort also receive oral NovaSoy soybean extract twice daily for the study duration
Patients are followed every 4 weeks
PROJECTED ACCRUAL Approximately 25-40 patients will be accrued for this study within 12-15 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|
| WSU-T-2001 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA022453 |
| U01CA062487 | NIH | None | None |
| P30CA022453 | NIH | None | None |
| WSU-C-2346 | None | None | None |
| NCI-4550 | None | None | None |