Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00025454
Status:
COMPLETED
Last Update Posted:
2010-02-08
First Post:
2001-10-11
Brief Title:
R115777 in Treating Patients With Advanced Solid Tumors
Sponsor:
City of Hope Medical Center
Organization:
City of Hope Medical Center
Study Overview
Official Title:
Phase I Trial of R115777 NSA 702818 in Advanced Malignant Solid Tumors
Status:
COMPLETED
Status Verified Date:
2010-02
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 tumor cells from dividing so they stop growing or die
PURPOSE Phase I trial to study the effectiveness of R115777 in treating patients who have advanced solid tumors
PURPOSE Phase I trial to study the effectiveness of R115777 in treating patients who have advanced solid tumors
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of R115777 in patients with advanced malignant solid tumors
Assess the toxicity of this drug in these patients
Determine preliminarily the efficacy of this drug in these patients
Determine the potential predictors of response in patients treated with drug
OUTLINE This is a multicenter dose-escalation study
Patients receive oral R115777 twice daily on weeks 1 and 3 Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of R115777 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
PROJECTED ACCRUAL A minimum of 20 patients will be accrued for this study within 12 months
Determine the maximum tolerated dose of R115777 in patients with advanced malignant solid tumors
Assess the toxicity of this drug in these patients
Determine preliminarily the efficacy of this drug in these patients
Determine the potential predictors of response in patients treated with drug
OUTLINE This is a multicenter dose-escalation study
Patients receive oral R115777 twice daily on weeks 1 and 3 Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of R115777 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
PROJECTED ACCRUAL A minimum of 20 patients will be accrued for this study within 12 months
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-4751 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA033572 |
| U01CA062505 | NIH | None | None |
| P30CA033572 | NIH | None | None |
| CHNMC-PHI-33 | None | None | None |