Ignite Creation Date:
2024-05-05 @ 5:09 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00390117
Status:
COMPLETED
Last Update Posted:
2023-08-04
First Post:
2006-10-18
Brief Title:
AT7519M in Treating Patients With Advanced or Metastatic Solid Tumors or Refractory Non-Hodgkins Lymphoma
Sponsor:
NCIC Clinical Trials Group
Organization:
Canadian Cancer Trials Group
Study Overview
Official Title:
A Phase I Study of AT7519M Given Twice Weekly in Patients With Advanced Incurable Malignancy
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 AT7519M may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth
PURPOSE This phase I trial is studying the side effects and best dose of AT7519M in treating patients with advanced or metastatic solid tumors or refractory non-Hodgkins lymphoma
PURPOSE This phase I trial is studying the side effects and best dose of AT7519M in treating patients with advanced or metastatic solid tumors or refractory non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Primary
Determine the recommended phase II dose of AT7519M in patients with advanced or metastatic solid tumors or refractory non-Hodgkins lymphoma
Determine the safety tolerability toxicity profile and dose-limiting toxicities of this drug in these patients
Determine the pharmacokinetic profile of this drug in these patients
Correlate the toxicity profile with pharmacokinetics of this drug in these patients
Secondary
Assess preliminarily the antitumor activity of this drug in these patients
OUTLINE This is an open-label dose-escalation multicenter study
Patients receive AT7519M IV over 1-3 hours on days 1 4 8 and 11 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of AT7519M until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity during course 1 Once the MTD has been determined up to 8 additional patients are treated at the MTD
Patients undergo blood collection periodically for pharmacokinetic studies Patients treated at the MTD also undergo tumor tissue biopsies or aspirates and blood collection periodically for additional pharmacodynamic and correlative biomarker studies
After completion of study therapy patients are followed at 4 weeks Patients with complete response partial response or stable disease are followed every 3 months thereafter until relapse
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study
Primary
Determine the recommended phase II dose of AT7519M in patients with advanced or metastatic solid tumors or refractory non-Hodgkins lymphoma
Determine the safety tolerability toxicity profile and dose-limiting toxicities of this drug in these patients
Determine the pharmacokinetic profile of this drug in these patients
Correlate the toxicity profile with pharmacokinetics of this drug in these patients
Secondary
Assess preliminarily the antitumor activity of this drug in these patients
OUTLINE This is an open-label dose-escalation multicenter study
Patients receive AT7519M IV over 1-3 hours on days 1 4 8 and 11 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of AT7519M until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity during course 1 Once the MTD has been determined up to 8 additional patients are treated at the MTD
Patients undergo blood collection periodically for pharmacokinetic studies Patients treated at the MTD also undergo tumor tissue biopsies or aspirates and blood collection periodically for additional pharmacodynamic and correlative biomarker studies
After completion of study therapy patients are followed at 4 weeks Patients with complete response partial response or stable disease are followed every 3 months thereafter until relapse
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 |
|---|---|---|---|
| CDR0000507621 | OTHER | PDQ | None |
| CAN-NCIC-IND177 | REGISTRY | None | None |