Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00098514
Status:
COMPLETED
Last Update Posted:
2017-12-18
First Post:
2004-12-07
Brief Title:
Talotrexin in Treating Patients With Advanced or Recurrent Solid Tumors
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
A Phase I Study Of PT523 In Patients With Solid Tumors
Status:
COMPLETED
Status Verified Date:
2017-12
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 such as talotrexin work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing
PURPOSE This phase I trial is studying side effects best way to give and best dose of talotrexin in treating patients with advanced or recurrent solid tumors
PURPOSE This phase I trial is studying side effects best way to give and best dose of talotrexin in treating patients with advanced or recurrent solid tumors
Detailed Description:
OBJECTIVES
Primary
Determine the maximum tolerated dose of talotrexin in patients in patients with advanced or recurrent solid tumors
Determine the safety of this drug in these patients
Determine the dose-limiting toxic effects of this drug in these patients
Secondary
Determine the pharmacokinetics of this drug in these patients
Correlate pharmacokinetic parameters of this drug or patient characteristics with drug-related toxicity in these patients
Determine preliminarily the antitumor efficacy of this drug in these patients
OUTLINE This is an open-label dose-escalation multicenter study
Patients receive talotrexin IV over 5 minutes on day 1 OR days 1 and 8 OR days 1 8 and 15 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Cohorts of 1-6 patients receive escalating doses of talotrexin 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 An additional 6-10 patients are treated at the MTD
Patients are followed at 1 month
PROJECTED ACCRUAL A total of 20-40 patients will be accrued for this study within 9-12 months
Primary
Determine the maximum tolerated dose of talotrexin in patients in patients with advanced or recurrent solid tumors
Determine the safety of this drug in these patients
Determine the dose-limiting toxic effects of this drug in these patients
Secondary
Determine the pharmacokinetics of this drug in these patients
Correlate pharmacokinetic parameters of this drug or patient characteristics with drug-related toxicity in these patients
Determine preliminarily the antitumor efficacy of this drug in these patients
OUTLINE This is an open-label dose-escalation multicenter study
Patients receive talotrexin IV over 5 minutes on day 1 OR days 1 and 8 OR days 1 8 and 15 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Cohorts of 1-6 patients receive escalating doses of talotrexin 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 An additional 6-10 patients are treated at the MTD
Patients are followed at 1 month
PROJECTED ACCRUAL A total of 20-40 patients will be accrued for this study within 9-12 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| HANABIO-DFCI-02000 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA006516 |
| P30CA006516 | NIH | None | None |
| CDR0000400150 | None | None | None |
| NCI-6400 | None | None | None |
| DFCI-IRB-03183 | None | None | None |