Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2026-02-25 @ 11:01 PM
Study NCT ID:
NCT00551850
Status:
COMPLETED
Last Update Posted:
2011-10-04
First Post:
2007-10-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Safety Study of an Oral EGFR Inhibitor, AV-412, Administered Three Times Weekly in Advanced Solid Tumor Patients
Sponsor:
AVEO Pharmaceuticals, Inc.
Organization:
Study Overview
Official Title:
A Phase I, Multi-Center, Dose-Escalation Trial to Determine the Safety, Tolerability, and Maximum Tolerated Dose of AV-412 Administered Orally Three Times Weekly to Subjects With Advanced Solid Tumors
Status:
COMPLETED
Status Verified Date:
2011-09
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:
The Epidermal Growth Factor Receptor (EGFR) is a validated target for the treatment of cancer, and agents targeting EGFR such as erlotinib (Tarceva®) are approved by the FDA for treatment of various solid tumors. AV-412 is a novel inhibitor of the EGFR-tyrosine kinase, with added activity against Her2 and other oncogenic kinases. Based on evidence of preclinical activity in various solid tumors, AV-412 is being developed as a possible novel treatment for cancer in humans.
PURPOSE: The purpose of this study is to test the safety and tolerability of AV-412, and determine the maximum tolerated dose of AV-412 when administered orally three times weekly.
PURPOSE: The purpose of this study is to test the safety and tolerability of AV-412, and determine the maximum tolerated dose of AV-412 when administered orally three times weekly.
Detailed Description:
This is an open-label, dose escalation trial, and all subjects will receive oral AV-412 administered three times weekly or once weekly for 4 weeks (1 cycle) to evaluate safety and tolerability of AV-412. Treatment duration will be a minimum of 2 consecutive dosing cycles (8 weeks), if tolerated.
* Upon completion of the 2 cycles, subjects with documented stable disease or an objective response may continue to receive therapy at the same dose and schedule previously utilized, as long as tolerability is acceptable, for up to 1 year. Treatment beyond 1 year from the time of enrollment will be reviewed on a case-by-case basis between the sponsor and investigator.
* Subjects experiencing unacceptable toxicities or with documented disease progression will be discontinued from further participation in the study Accrual to next cohort will occur only after acceptable tolerance has been demonstrated throughout Cycle 1, and only after consultation with medical monitor.
* Upon completion of the 2 cycles, subjects with documented stable disease or an objective response may continue to receive therapy at the same dose and schedule previously utilized, as long as tolerability is acceptable, for up to 1 year. Treatment beyond 1 year from the time of enrollment will be reviewed on a case-by-case basis between the sponsor and investigator.
* Subjects experiencing unacceptable toxicities or with documented disease progression will be discontinued from further participation in the study Accrual to next cohort will occur only after acceptable tolerance has been demonstrated throughout Cycle 1, and only after consultation with medical monitor.
Study Oversight
Has Oversight DMC:
False
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?: