Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004030
Status:
COMPLETED
Last Update Posted:
2011-03-24
First Post:
1999-12-10
Brief Title:
VX-853 in Treating Patients With Solid Tumors Who Are Receiving Liposomal Doxorubicin
Sponsor:
Georgetown University
Organization:
Georgetown University
Study Overview
Official Title:
A Phase III Study of the Pharmacokinetics Tolerability and Safety of Administration of VX-853 to Patients Receiving Single Agent Therapy With Doxorubicin HCI
Status:
COMPLETED
Status Verified Date:
2001-01
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 III trial to study the effectiveness of VX-853 in treating patients who have solid tumors who are receiving liposomal doxorubicin
PURPOSE Phase III trial to study the effectiveness of VX-853 in treating patients who have solid tumors who are receiving liposomal doxorubicin
Detailed Description:
OBJECTIVES I Determine the safety and tolerability of VX-853 in combination with doxorubicin HCl liposome in patients with relapsed or incurable solid tumors II Obtain pharmacokinetic profiles for various dosages of VX-853 administered in combination with doxorubicin HCl liposome III Achieve whole blood concentrations of VX-853 in the predicted therapeutically effective range and characterize the pharmacokinetics at these doses IV Document antitumor effects of VX-853 in combination with doxorubicin HCl liposome in these patients
OUTLINE This is a dose escalation study of VX-853 Patients receive VX-853 orally every 8 hours on days 1-3 and doxorubicin HCL liposome IV over approximately 15 minutes beginning 26 hours after starting VX-853 Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of VX-853 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 dose limiting toxicity
PROJECTED ACCRUAL A maximum of 45 patients will be accrued for this study within approximately 18 months
OUTLINE This is a dose escalation study of VX-853 Patients receive VX-853 orally every 8 hours on days 1-3 and doxorubicin HCL liposome IV over approximately 15 minutes beginning 26 hours after starting VX-853 Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of VX-853 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 dose limiting toxicity
PROJECTED ACCRUAL A maximum of 45 patients will be accrued for this study within approximately 18 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-V97-1275 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA051008 |
| P30CA051008 | NIH | None | None |
| GUMC-96007 | None | None | None |
| VX-95-853-001 | None | None | None |
| VX-GUMC-96007 | None | None | None |