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Eligibility
for people ages 18 years to 99 years
Location
at San Francisco, California and other locations
Dates
study started
estimated completion:
Principal Investigator

Description

Summary

This study is evaluating the safety and pharmacokinetics of ABT-414 in subjects with glioblastoma multiforme.

Official Title

A Phase 1 Study Evaluating the Safety and Pharmacokinetics of ABT-414 for Subjects With Glioblastoma Multiforme

Keywords

Glioblastoma Multiforme GBM Temozolomide Dacarbazine

Eligibility

You can join if…

Open to people ages 18 years to 99 years

  1. Glioblastoma Multiforme (GBM)
  2. 70 or above on Karnofsky Performance Status
  3. Adequate bone marrow function
  4. Recurrent GBM per RANO criteria
  5. Subjects must have confirmed EGFR amplification by central lab

You CAN'T join if...

  1. For Subjects with recurrent GBM in Arm B, subject has received prior treatment with bevacizumab, nitrosourea, or has secondary GBM
  2. For Subjects with recurrent GBM in Arm C, subject has received prior treatment with bevacizumab, or has secondary GBM
  3. Allergies to temozolomide, dacarbazine, IgG containing agents
  4. Anti-cancer treatment 28 days prior to study Day 1, except in Arm B expanded cohort temozolomide therapy is allowed
  5. Subjects that have had more than one disease recurrence

Locations

  • Site Reference ID/Investigator# 137975
    Los Angeles, California, 90095, USA

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AbbVie
ID
NCT01800695
Phase
Phase 1
Lead Scientist
Nicholas Butowski
Study Type
Interventional
Last Updated
January 2017