Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00121264
Status:
COMPLETED
Last Update Posted:
2014-06-17
First Post:
2005-07-19
Brief Title:
17-AAG and Sorafenib in Treating Patients With Unresectable or Metastatic Solid Tumors
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Dose-Escalation Study of Intravenous 17-Allylaminogeldanamycin 17-AAG NSC 330507and Oral BAY 43-9006 NSC 724772 Administered in Patients With Pretreated Advanced Solid Tumors
Status:
COMPLETED
Status Verified Date:
2013-01
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:
This phase I trial is studying the side effects and best dose of 17-AAG when given together with sorafenib in treating patients with unresectable or metastatic solid tumors Drugs used in chemotherapy such as 17-AAG work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor Giving 17-AAG together with sorafenib may kill more tumor cells
Detailed Description:
PRIMARY OBJECTIVES
I To recommend a phase II dose for 17AAG once weekly intravenously for 3 of 4 weeks in combination with BAY 43-9006 twice daily orally by determining the feasibility safety dose limiting toxicities and the maximally tolerated dose
SECONDARY OBJECTIVES
I To evaluate the modulation of pharmacodynamic effects and to investigate the interaction between the two mechanisms of action when used in combination by Studying surrogate tissue and tumor cell signaling by Western blotting Evaluating tumor blood flow utilizing dynamic contrast enhanced MRI
II To study any pharmacokinetic interactions between these two agents III To assess preliminary anti-tumor activity of this combination
OUTLINE This is an open-label multicenter dose-escalation study of 17-N-allylamino 17-demethoxygeldanamycin 17-AAG
Patients receive oral sorafenib twice daily on days -14 to 28 in course 1 and on days 1-28 in all subsequent courses Patients also receive 17-AAG IV over 3 hours on days 1 8 and 15 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Cohorts of 5-6 patients receive escalating doses of 17-AAG until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that which 2 of 6 patients experience dose-limiting toxicity
After completion of study therapy patients are followed for 60 days
I To recommend a phase II dose for 17AAG once weekly intravenously for 3 of 4 weeks in combination with BAY 43-9006 twice daily orally by determining the feasibility safety dose limiting toxicities and the maximally tolerated dose
SECONDARY OBJECTIVES
I To evaluate the modulation of pharmacodynamic effects and to investigate the interaction between the two mechanisms of action when used in combination by Studying surrogate tissue and tumor cell signaling by Western blotting Evaluating tumor blood flow utilizing dynamic contrast enhanced MRI
II To study any pharmacokinetic interactions between these two agents III To assess preliminary anti-tumor activity of this combination
OUTLINE This is an open-label multicenter dose-escalation study of 17-N-allylamino 17-demethoxygeldanamycin 17-AAG
Patients receive oral sorafenib twice daily on days -14 to 28 in course 1 and on days 1-28 in all subsequent courses Patients also receive 17-AAG IV over 3 hours on days 1 8 and 15 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Cohorts of 5-6 patients receive escalating doses of 17-AAG until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that which 2 of 6 patients experience dose-limiting toxicity
After completion of study therapy patients are followed for 60 days
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-2012-03194 | REGISTRY | None | None |
| CDR434803 | None | None | None |
| C-2890 | OTHER | None | None |
| 6972 | OTHER | None | None |
| U01CA062487 | NIH | None | None |
| P30CA022453 | NIH | CTEP | httpsreporternihgovquickSearchP30CA022453 |