NCT00551850

A Safety Study of an Oral EGFR Inhibitor, AV-412, Administered Three Times Weekly in Advanced Solid Tumor Patients

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: AVEO Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Advanced Cancer
• Refractory Cancer

Interventions

Type	Name	Description
DRUG	AV-412	oral solid dosage form administered three times weekly for 4 weeks (1 cycle)

Timeline

• Start date: 2007-10-01
• Primary completion: 2009-10-01
• Completion: 2010-05-01
• First posted: 2007-10-31
• Last updated: 2011-10-04

Locations

4 sites across 1 country: United States