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

NCT00381654 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2011-10-04

No results posted yet for this study

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.

Conditions

  • Tumor

Interventions

DRUG

AV-412

Solid oral dosage; 4 dosage strengths; 25, 50, 100, or 200 mg per capsule Dosing Frequency: Once daily dosing for 4 weeks (4 weeks equals 1 cycle)

Sponsors & Collaborators

  • AVEO Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Manuel Hidalgo, MD, PhD · Johns Hopkins University

  • Justina L Martinez, MD · Hospital Universitatrio Austral

  • Carmen S. Puparelli, MD · Instituto Médico Especializado Alexander Fleming

  • Belén R. Viquiera, M.D. · Centro Integral Oncológica Clara Campal

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2009-12-31
Completion
2010-02-28

Countries

  • United States
  • Argentina

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00381654 on ClinicalTrials.gov