Ignite Creation Date:
2024-05-05 @ 5:24 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00443976
Status:
COMPLETED
Last Update Posted:
2023-08-04
First Post:
2007-03-05
Brief Title:
Aurora Kinase Inhibitor AT9283 in Treating Patients With Advanced or Metastatic Solid Tumors or Non-Hodgkins Lymphoma
Sponsor:
NCIC Clinical Trials Group
Organization:
Canadian Cancer Trials Group
Study Overview
Official Title:
A Phase I Study of AT9283 Given As a 24 Hour Infusion on Days 1 and 8 Every Three Weeks 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 Aurora kinase inhibitor AT9283 AT9283 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 AT9283 in treating patients with advanced or metastatic solid tumors or non-Hodgkins lymphoma
PURPOSE This phase I trial is studying the side effects and best dose of AT9283 in treating patients with advanced or metastatic solid tumors or non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose and recommended phase II dose of Aurora kinase inhibitor AT9283 AT9283 in patients with incurable advanced or metastatic solid tumors or non-Hodgkins lymphoma
Determine the safety tolerability toxicity profile dose-limiting toxicity and pharmacokinetic profile of this drug in these patients
Correlate the toxicity profile with the pharmacokinetics of this drug in these patients
Assess preliminarily evidence of antitumor activity of this drug in these patients
Determine the pharmacodynamic activity of this drug in these patients and correlate with biological endpoints
OUTLINE This is an open-label dose-escalation multicenter study
Patients receive Aurora kinase inhibitor AT9283 AT9283 IV over 24 hours on days 1 and 8 Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of AT9283 until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity The dose preceding the MTD is the recommended phase II dose RPTD Up to 8 additional patients are treated at the RPTD
Patients treated at the RPTD undergo skin and tumor tissue biopsy and blood collection at baseline and on days 2 andor 3 Samples are examined by pharmacokinetic and pharmacodynamic analysis including immunohistochemistry immunocytochemistry western blotting immunoenzyme techniques flow cytometry and reverse transcriptase-polymerase chain reaction for biological markers
After completion of study treatment patients are followed at 4 weeks and then every 3 months until disease progression
PROJECTED ACCRUAL Up to 30 patients will be accrued for this study
Determine the maximum tolerated dose and recommended phase II dose of Aurora kinase inhibitor AT9283 AT9283 in patients with incurable advanced or metastatic solid tumors or non-Hodgkins lymphoma
Determine the safety tolerability toxicity profile dose-limiting toxicity and pharmacokinetic profile of this drug in these patients
Correlate the toxicity profile with the pharmacokinetics of this drug in these patients
Assess preliminarily evidence of antitumor activity of this drug in these patients
Determine the pharmacodynamic activity of this drug in these patients and correlate with biological endpoints
OUTLINE This is an open-label dose-escalation multicenter study
Patients receive Aurora kinase inhibitor AT9283 AT9283 IV over 24 hours on days 1 and 8 Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of AT9283 until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity The dose preceding the MTD is the recommended phase II dose RPTD Up to 8 additional patients are treated at the RPTD
Patients treated at the RPTD undergo skin and tumor tissue biopsy and blood collection at baseline and on days 2 andor 3 Samples are examined by pharmacokinetic and pharmacodynamic analysis including immunohistochemistry immunocytochemistry western blotting immunoenzyme techniques flow cytometry and reverse transcriptase-polymerase chain reaction for biological markers
After completion of study treatment patients are followed at 4 weeks and then every 3 months until disease progression
PROJECTED ACCRUAL Up to 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 |
|---|---|---|---|
| ASTEX-CAN-NCIC-IND181 | REGISTRY | Astex Therapeutics Inc | None |
| CDR0000523837 | REGISTRY | None | None |
| CAN-NCIC-IND181 | REGISTRY | None | None |