Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006085
Status:
UNKNOWN
Last Update Posted:
2013-12-19
First Post:
2000-08-03
Brief Title:
CP-609754 in Treating Patients With Advanced Solid Tumors
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I Open-Label Study of the Safety Toleration and Pharmacokinetics of CP-609754 a Farnesyl Transferase Inhibitor in Subjects With Advanced Malignant Tumors
Status:
UNKNOWN
Status Verified Date:
2001-12
Last Known Status:
ACTIVE_NOT_RECRUITING
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 CP-609754 in treating patients who have advanced solid tumors
PURPOSE Phase I trial to study the effectiveness of CP-609754 in treating patients who have advanced solid tumors
Detailed Description:
OBJECTIVES I Determine the safety tolerability pharmacokinetics and maximum tolerated dose of CP-609754 in patients with advanced solid tumors II Determine the predictability duration intensity onset reversibility and dose relationship of any observed toxicities in these patients when treated with this regimen III Determine any preliminary evidence of antitumor activity of this treatment as assessed by response rate and time to disease progression in this patient population
OUTLINE This is a dose escalation study Patients receive oral CP-609754 1-2 times daily Treatment continues every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of CP-609754 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 6 patients experience dose limiting toxicities Patients are followed at 4 weeks
PROJECTED ACCRUAL Approximately 44-56 patients will be accrued for this study within 12 months
OUTLINE This is a dose escalation study Patients receive oral CP-609754 1-2 times daily Treatment continues every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of CP-609754 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 6 patients experience dose limiting toxicities Patients are followed at 4 weeks
PROJECTED ACCRUAL Approximately 44-56 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-G00-1824 | None | None | None |
| MCC-12222 | None | None | None |
| PFIZER-A3321001 | None | None | None |