Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004009
Status:
COMPLETED
Last Update Posted:
2019-11-07
First Post:
1999-11-01
Brief Title:
R115777 in Treating Patients With Refractory or Recurrent Acute Leukemia or Chronic Myelogenous Leukemia
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
A Phase I Study to Determine Biological Endpoints of Up to 21 Day Dosing of the Farnesyltransferase Inhibitor R115777 IND 52302 for Refractory and Relapsed Adult Leukemias Summary Last Modified 91999
Status:
COMPLETED
Status Verified Date:
2019-11
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 use different ways to stop cancer cells from dividing so they stop growing or die
PURPOSE Phase I trial to study the effectiveness of R115777 in treating patients who have refractory or recurrent acute leukemia or chronic myelogenous leukemia
PURPOSE Phase I trial to study the effectiveness of R115777 in treating patients who have refractory or recurrent acute leukemia or chronic myelogenous leukemia
Detailed Description:
OBJECTIVES I Determine toxicities and pharmacokinetics of oral R115777 in adults with refractory acute leukemia or accelerated or blastic phase chronic myelogenous leukemia II Determine the effect of R115777 on farnesylation within leukemia cells III Determine any clinical response at least 50 decrease in circulating leukemia cells to R115777 by these patients
OUTLINE This is a dose escalation multicenter study Patients receive oral R115777 for 7-21 days Patients who achieve complete response CR or partial response PR following 1-4 courses of treatment may receive up to 4 additional courses Patients with stable disease may receive another 7-21 day course If CR or PR is then achieved patients may receive up to 4 additional courses Cohorts of 6-12 patients receive escalating doses of R115777 until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which between 17 and 33 of patients experience dose limiting toxicity
PROJECTED ACCRUAL A total of 24 patients will be accrued for this study within 2 years
OUTLINE This is a dose escalation multicenter study Patients receive oral R115777 for 7-21 days Patients who achieve complete response CR or partial response PR following 1-4 courses of treatment may receive up to 4 additional courses Patients with stable disease may receive another 7-21 day course If CR or PR is then achieved patients may receive up to 4 additional courses Cohorts of 6-12 patients receive escalating doses of R115777 until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which between 17 and 33 of patients experience dose limiting toxicity
PROJECTED ACCRUAL A total of 24 patients will be accrued for this study within 2 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|
| NCI-T99-0030 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000067221 | REGISTRY | None | None |
| MSGCC-0398115 | None | None | None |
| URCC-980300 | None | None | None |