Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003979
Status:
WITHDRAWN
Last Update Posted:
2012-07-11
First Post:
1999-11-01
Brief Title:
CHS 828 in Treating Patients With Solid Tumors
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
Phase I and Pharmacokinetics Study to Determine the Safety of CHS 828 in Patients With a Solid Tumor on a Single Oral Dose Repeated Every 3 Weeks
Status:
WITHDRAWN
Status Verified Date:
2012-07
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 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 CHS 828 in treating patients who have solid tumors
PURPOSE Phase I trial to study the effectiveness of CHS 828 in treating patients who have solid tumors
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of oral CHS 828 in patients with solid tumors
Determine the qualitative and quantitative toxic effects of this regimen in these patients
Determine a safe dose of this regimen for phase II evaluation
Determine the pharmacokinetic profile of this regimen in these patients
Determine any antitumor activity in these patients
OUTLINE Patients receive oral CHS 828 every 3 weeks Treatment continues for at least 2 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of CHS 828 until the maximum tolerated dose MTD is reached The MTD is defined as the dose at which 2 of 6 patients experience dose limiting toxicity
Patients are followed for up to 4 weeks
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study within 12 months
Determine the maximum tolerated dose of oral CHS 828 in patients with solid tumors
Determine the qualitative and quantitative toxic effects of this regimen in these patients
Determine a safe dose of this regimen for phase II evaluation
Determine the pharmacokinetic profile of this regimen in these patients
Determine any antitumor activity in these patients
OUTLINE Patients receive oral CHS 828 every 3 weeks Treatment continues for at least 2 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of CHS 828 until the maximum tolerated dose MTD is reached The MTD is defined as the dose at which 2 of 6 patients experience dose limiting toxicity
Patients are followed for up to 4 weeks
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study within 12 months
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 |
|---|---|---|---|
| EORTC-16985 | None | None | None |