Ignite Creation Date:
2024-05-05 @ 4:50 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00324597
Status:
UNKNOWN
Last Update Posted:
2013-09-17
First Post:
2006-05-10
Brief Title:
AMG 706 and Gemcitabine in Treating Patients With Advanced Solid Tumors or Lymphoma
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase Ib Open-Label Sequential Dose-Finding Study of AMG 706 in Combination With Gemcitabine to Treat Subjects With Solid Tumors
Status:
UNKNOWN
Status Verified Date:
2007-04
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE AMG 706 may stop the growth of cancer cells by blocking blood flow to the cancer or by blocking some of the enzymes needed for cell growth Drugs used in chemotherapy such as gemcitabine work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing Giving AMG 706 together with gemcitabine may kill more cancer cells
PURPOSE This phase I trial is studying the side effects and best dose of AMG 706 when given together with gemcitabine in treating patients with advanced solid tumors or lymphoma
PURPOSE This phase I trial is studying the side effects and best dose of AMG 706 when given together with gemcitabine in treating patients with advanced solid tumors or lymphoma
Detailed Description:
OBJECTIVES
Primary
Determine the maximum tolerated dose and safety of AMG 706 when given in combination with gemcitabine hydrochloride in patients with advanced solid tumors or lymphoma
Secondary
Determine the pharmacokinetic profiles of this regimen in these patients
OUTLINE This is a multicenter open-label dose-escalation study of AMG 706
Patients receive oral AMG 706 once daily on days 2-56 and gemcitabine hydrochloride IV over 30 minutes on days 1 8 15 22 29 36 and 43 of course 1 For all subsequent courses patients receive oral AMG 706 on days 1-28 and gemcitabine hydrochloride IV over 30 minutes on days 1 8 and 15 Treatment repeats every 4 weeks for up to 10 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of AMG 706 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 3 of 6 patients experience dose-limiting toxicity
During the first course of study treatment patients undergo blood collection periodically for pharmacokinetic analysis
After completion of study treatment patients are followed periodically for up to 5 years
PROJECTED ACCRUAL Approximately 18 patients will be accrued for this study
Primary
Determine the maximum tolerated dose and safety of AMG 706 when given in combination with gemcitabine hydrochloride in patients with advanced solid tumors or lymphoma
Secondary
Determine the pharmacokinetic profiles of this regimen in these patients
OUTLINE This is a multicenter open-label dose-escalation study of AMG 706
Patients receive oral AMG 706 once daily on days 2-56 and gemcitabine hydrochloride IV over 30 minutes on days 1 8 15 22 29 36 and 43 of course 1 For all subsequent courses patients receive oral AMG 706 on days 1-28 and gemcitabine hydrochloride IV over 30 minutes on days 1 8 and 15 Treatment repeats every 4 weeks for up to 10 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of AMG 706 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 3 of 6 patients experience dose-limiting toxicity
During the first course of study treatment patients undergo blood collection periodically for pharmacokinetic analysis
After completion of study treatment patients are followed periodically for up to 5 years
PROJECTED ACCRUAL Approximately 18 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 |
|---|---|---|---|
| UCLA-0506055-01 | None | None | None |