Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00073944
Status:
COMPLETED
Last Update Posted:
2013-05-30
First Post:
2003-12-10
Brief Title:
BCX-1777 in Treating Patients With Refractory Cancer
Sponsor:
BioCryst Pharmaceuticals
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I Pharmacology Study Of Oral And Intravenous BCX-1777 In Patients With Refractory T-Cell And Non-T-Cell Malignancies
Status:
COMPLETED
Status Verified Date:
2004-07
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 BCX-1777 may stop the growth of cancer cells by blocking the enzymes necessary for their growth
PURPOSE Phase I trial to study the effectiveness of BCX-1777 in treating patients who have refractory cancer
PURPOSE Phase I trial to study the effectiveness of BCX-1777 in treating patients who have refractory cancer
Detailed Description:
OBJECTIVES
Primary
Determine the maximum tolerated dose of BCX-1777 in patients with refractory T-cell or non-T-cell malignancies
Determine the safety and dose-limiting toxicity of this drug in these patients
Secondary
Determine the pharmacokinetics of single oral and single and multiple IV doses of this drug in these patients
Determine the oral bioavailability of this drug in these patients
Determine preliminarily the antitumor activity of this drug in these patients
OUTLINE This is an open-label nonrandomized dose-escalation multicenter study
Courses 1 and 2 Patients receive oral BCX-1777 on days 1 and 15 and BCX-1777 IV over 30 minutes on days 8 and 22
Course 3 Beginning approximately 6 days after the completion of courses 1 and 2 patients receive BCX-1777 IV over 30 minutes once daily on days 1-5 and 8-12 total of 10 doses
NOTE - 1 day
Patients with stable disease or better and no dose-limiting toxicity DLT may receive an additional 10-dose treatment course as in course 3 after a 10- to 16-day drug-free interval
Treatment continues in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of BCX-1777 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 DLT
Patients are followed at 14 and 30 days
PROJECTED ACCRUAL A total of 3-24 patients will be accrued for this study
Primary
Determine the maximum tolerated dose of BCX-1777 in patients with refractory T-cell or non-T-cell malignancies
Determine the safety and dose-limiting toxicity of this drug in these patients
Secondary
Determine the pharmacokinetics of single oral and single and multiple IV doses of this drug in these patients
Determine the oral bioavailability of this drug in these patients
Determine preliminarily the antitumor activity of this drug in these patients
OUTLINE This is an open-label nonrandomized dose-escalation multicenter study
Courses 1 and 2 Patients receive oral BCX-1777 on days 1 and 15 and BCX-1777 IV over 30 minutes on days 8 and 22
Course 3 Beginning approximately 6 days after the completion of courses 1 and 2 patients receive BCX-1777 IV over 30 minutes once daily on days 1-5 and 8-12 total of 10 doses
NOTE - 1 day
Patients with stable disease or better and no dose-limiting toxicity DLT may receive an additional 10-dose treatment course as in course 3 after a 10- to 16-day drug-free interval
Treatment continues in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of BCX-1777 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 DLT
Patients are followed at 14 and 30 days
PROJECTED ACCRUAL A total of 3-24 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CCF-5909 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000341332 | REGISTRY | None | None |