Safety/Tolerability Study of AV-412 in Subjects With Refractory or Relapsed Solid Tumor Malignancies

Phase 1

Terminated

• Conditions: Tumor
• Interventions: Drug: AV-412

• Registration Number: NCT00381654
• Lead Sponsor: AVEO Pharmaceuticals, Inc.

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.

Study Timeline

• Study First Submitted: 2006-09-27
• Study First Submitted QC: 2006-09-27
• Study First Posted: 2006-09-28
• Study Start: 2006-10
• Primary Completion: 2009-12
• Study Completion: 2010-02
• Status Verified: 2011-09
• Last Update Submitted: 2011-09-30
• Last Update Posted: 2011-10-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	AV-412	Daily oral administration of AV-412

Primary Outcome Measures

Name	Time	Method
To evaluate the safety, tolerability, and dose-limiting toxicities (DLT), and determine the maximum tolerated dose (MTD) of AV-412 when administered once daily by the oral route for 4 weeks (4 weeks equals one dosing cycle)	one year

Secondary Outcome Measures

Name	Time	Method
Preliminary evaluation of the antineoplastic activity of AV-412 (assessed by evidence and duration of disease stabilization or objective response, and time to disease progression)	two years
To characterize the pharmacokinetic (PK) profile of AV-412 in all patients. Extensive PK collection and assay to be performed in expanded MTD Cohorts	18 months
Evaluate potential pharmacodynamic (PD) markers of AV-412 action, in expanded MTD Cohorts ONLY	two years

Trial Locations

Locations (3)

Hospital Universitatrio Austral; 🇦🇷 Buenos Aires, Argentina

Instituto Médico Especializado Alexander Fleming; 🇦🇷 Buenos Aires, Argentina

Johns Hopkins University School of Medicine; 🇺🇸 Baltimore, Maryland, United States