Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003721
Status:
COMPLETED
Last Update Posted:
2012-06-29
First Post:
1999-11-01
Brief Title:
Chemotherapy in Treating Patients With Advanced Solid Tumors
Sponsor:
The University of Texas Health Science Center at San Antonio
Organization:
The University of Texas Health Science Center at San Antonio
Study Overview
Official Title:
A Phase I Pharmacologic and Biologic Study of Col-3 NSC683551 Administered on a 28-Day Oral Dosing Schedule in Patients With Advanced Solid Tumors
Status:
COMPLETED
Status Verified Date:
2012-06
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 COL-3 in treating patients who have advanced solid tumors
PURPOSE Phase I trial to study the effectiveness of COL-3 in treating patients who have advanced solid tumors
Detailed Description:
OBJECTIVES I Define the maximum tolerated dose of COL-3 in patients with advanced solid tumors II Identify the dose limiting toxicity and safety profile of COL-3 in these patients III Define the pharmacokinetics and pharmacodynamics of COL-3 in these patients IV Observe any evidence of antitumor activity through standard response criteria or biologic surrogate markers
OUTLINE This is a dose escalation study Patients receive oral COL-3 once daily Treatment continues in the absence of disease progression and unacceptable toxic effects Cohorts of 3-6 patients each receive escalating doses of COL-3 Dose escalation to the next level occurs after 3 patients have completed 28 days of treatment without dose limiting toxicity DLT Dose escalation continues until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 or more of 6 patients experience DLT
PROJECTED ACCRUAL Up to 30 patients will be accrued within 1 year for this study
OUTLINE This is a dose escalation study Patients receive oral COL-3 once daily Treatment continues in the absence of disease progression and unacceptable toxic effects Cohorts of 3-6 patients each receive escalating doses of COL-3 Dose escalation to the next level occurs after 3 patients have completed 28 days of treatment without dose limiting toxicity DLT Dose escalation continues until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 or more of 6 patients experience DLT
PROJECTED ACCRUAL Up to 30 patients will be accrued within 1 year for this study
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 |
|---|---|---|---|
| U01CA069853 | NIH | None | None |
| P30CA054174 | NIH | None | None |
| UTHSC-9785011153 | OTHER | None | None |
| SACI-IDD-97-27 | OTHER | None | None |
| NCI-T97-0091 | OTHER | NCI | httpsreporternihgovquickSearchP30CA054174 |