Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00061880
Status:
COMPLETED
Last Update Posted:
2013-05-30
First Post:
2003-06-05
Brief Title:
BCX-1777 in Treating Patients With Refractory Cutaneous T-Cell Lymphoma
Sponsor:
BioCryst Pharmaceuticals
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase 1-2 Multi-Center Study of Intravenous BCX-1777 in Patients With Refractory Cutaneous T-Cell Lymphoma CTCL
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 cancer cell growth
PURPOSE Phase III trial to study the effectiveness BCX-1777 in treating patients who have refractory cutaneous T-cell lymphoma
PURPOSE Phase III trial to study the effectiveness BCX-1777 in treating patients who have refractory cutaneous T-cell lymphoma
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of BCX-1777 in patients with refractory cutaneous T-cell lymphoma
Determine the efficacy of this drug in these patients
Determine the toxicity profile of this drug in these patients
Correlate plasma concentration of deoxyguanosine with clinical response and toxicity in patients treated with this drug
Determine the provisional optimal biological dose of this drug in these patients
OUTLINE This is an open-label nonrandomized dose-escalation multicenter study
Phase I Patients receive BCX-1777 IV over 30 minutes every 12 hours on days 1-5 a total of 9 doses Treatment repeats every 21 days for up to 3 courses 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 at which no more than 2 of 6 patients experience dose-limiting toxicity
Phase II Patients receive treatment as in phase I at the MTD of BCX-1777 Patients including those who respond to treatment are followed at 14 and 30 days monthly for 6 months every 2 months for 6 months and then every 6 months thereafter
PROJECTED ACCRUAL A total of 3-64 patients 3-24 for phase I and 40 for phase II will be accrued for this study
Determine the maximum tolerated dose of BCX-1777 in patients with refractory cutaneous T-cell lymphoma
Determine the efficacy of this drug in these patients
Determine the toxicity profile of this drug in these patients
Correlate plasma concentration of deoxyguanosine with clinical response and toxicity in patients treated with this drug
Determine the provisional optimal biological dose of this drug in these patients
OUTLINE This is an open-label nonrandomized dose-escalation multicenter study
Phase I Patients receive BCX-1777 IV over 30 minutes every 12 hours on days 1-5 a total of 9 doses Treatment repeats every 21 days for up to 3 courses 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 at which no more than 2 of 6 patients experience dose-limiting toxicity
Phase II Patients receive treatment as in phase I at the MTD of BCX-1777 Patients including those who respond to treatment are followed at 14 and 30 days monthly for 6 months every 2 months for 6 months and then every 6 months thereafter
PROJECTED ACCRUAL A total of 3-64 patients 3-24 for phase I and 40 for phase II 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 |
|---|---|---|---|
| CDR0000301763 | REGISTRY | PDQ Physician Data Query | None |