Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003713
Status:
COMPLETED
Last Update Posted:
2018-08-29
First Post:
1999-11-01
Brief Title:
Chemotherapy in Treating Patients With Advanced or Metastatic Solid Tumors
Sponsor:
Genzyme a Sanofi Company
Organization:
Sanofi
Study Overview
Official Title:
A Phase I Pharmacokinetic and Treatment Duration and Escalation Study of Intravenous Intoplicine Administered as a 5 to 21-Day Continuous Infusion Every 4 Weeks
Status:
COMPLETED
Status Verified Date:
2001-05
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 intoplicine in treating patients who have advanced or metastatic solid tumors
PURPOSE Phase I trial to study the effectiveness of intoplicine in treating patients who have advanced or metastatic solid tumors
Detailed Description:
OBJECTIVES I Determine the intolerable dose level of intoplicine in patients with locally advanced or metastatic cancer II Determine recommended phase II dose of intoplicine in these patients III Determine the principal and dose limiting toxicities of intoplicine in these patients and determine the duration and reversibility of the toxicities IV Determine the magnitude of plasma concentrations that are achieved and maintained on this regimen and relate this parameter to toxicity outcome and antitumor activity V Determine preliminary evidence of antitumor activity of intoplicine in these patients
OUTLINE This is a dose escalation study The first 3 patients receive intoplicine IV by continuous infusion for 5 days Treatment is repeated every 28 days in the absence of disease progression or unacceptable toxicity Subsequent cohorts of 3-6 patients receive escalating doses of intoplicine first by increasing the number of days that the drug is infused to 10 15 and 21 then by increasing the dosage and keeping the infusion time constant at 21 days The intolerable dose level is defined as the lowest dose at which at least 2 of 3 or 6 patients experience dose limiting toxicity during course 1 or 2
PROJECTED ACCRUAL A total of 20-35 patients will be accrued for this study
OUTLINE This is a dose escalation study The first 3 patients receive intoplicine IV by continuous infusion for 5 days Treatment is repeated every 28 days in the absence of disease progression or unacceptable toxicity Subsequent cohorts of 3-6 patients receive escalating doses of intoplicine first by increasing the number of days that the drug is infused to 10 15 and 21 then by increasing the dosage and keeping the infusion time constant at 21 days The intolerable dose level is defined as the lowest dose at which at least 2 of 3 or 6 patients experience dose limiting toxicity during course 1 or 2
PROJECTED ACCRUAL A total of 20-35 patients will be accrued 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 |
|---|---|---|---|
| NCI-V98-1507 | None | None | None |
| ILEX-INTO101-A6 | None | None | None |
| ILEX-INTO101-A5 | None | None | None |
| SACI-IDD-97-02 | None | None | None |
| UTHSC-9785011033 | None | None | None |