Ignite Creation Date:
2024-05-05 @ 5:06 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00381654
Status:
TERMINATED
Last Update Posted:
2011-10-04
First Post:
2006-09-27
Brief Title:
SafetyTolerability Study of AV-412 in Subjects With Refractory or Relapsed Solid Tumor Malignancies
Sponsor:
AVEO Pharmaceuticals Inc
Organization:
AVEO Pharmaceuticals Inc
Study Overview
Official Title:
A Phase 1 Sequential Cohort Dose Escalation Trial to Determine the Safety Tolerability and Maximum Tolerated Dose of Daily Oral Administration of AV-412 in Patients With Refractory or Relapsed Solid Tumor Malignancies
Status:
TERMINATED
Status Verified Date:
2011-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study did not meet pre-specified objectives
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
AV-412 is a new oral therapy developed to inhibit the growth of solid tumors in patients who have not responded to standard therapy or surgical interventions or who have experienced relapse This study will test the safety of AV-412 and determine the maximum tolerated dose for the treatment of solid tumors
Detailed Description:
Although progress has been made patients with malignancies often either progress after the traditional approach of chemotherapy surgery or radiotherapy or are not candidates for these approaches because of the advances stage of disease Novel therapies that may offer greater potential than those currently available are urgently needed
AV 412 is a potent inhibitor of human epidermal growth factor family receptor tyrosine kinases TKIs and represents a growing class of anti-cancer agents The recent introduction of TKIs has opened the door to new approaches to cancer treatment in which the goals of therapy are to halt disease progression ameliorate symptoms and improve patient quality of life AV412 may inhibit growth of solid tumors with fewer and less debilitating side effects
This study is designed to determine the safety tolerability and maximum tolerated dose of daily oral administration of AV 412 Patients will be assigned to escalating drug dose cohorts to determine the optimal dose Evaluations to determine tolerability include PK PD and the adverse events which occur during the course of study drug administration
AV 412 is a potent inhibitor of human epidermal growth factor family receptor tyrosine kinases TKIs and represents a growing class of anti-cancer agents The recent introduction of TKIs has opened the door to new approaches to cancer treatment in which the goals of therapy are to halt disease progression ameliorate symptoms and improve patient quality of life AV412 may inhibit growth of solid tumors with fewer and less debilitating side effects
This study is designed to determine the safety tolerability and maximum tolerated dose of daily oral administration of AV 412 Patients will be assigned to escalating drug dose cohorts to determine the optimal dose Evaluations to determine tolerability include PK PD and the adverse events which occur during the course of study drug administration
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