A Study Evaluating the Safety and Pharmacokinetics of ABT-414 in Subjects With Glioblastoma Multiforme in Combination With Radiation Plus Temozolomide or Temozolomide Alone

Status: Recruiting
Phase:
Diagnosis: Brain/Neuro Cancer: Recurrent Glioblastoma
NCT ID: NCT01800695 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 13-126

 

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

 

Conducting Institutions:
Brigham and Women's Hospital, Dana-Farber Cancer Institute

Overall PI:
David Reardon, MD, Dana Farber Cancer Institute

Site-responsible Investigators:

Contacts:
Dana-Farber Cancer Institute: Lisa Doherty, ldoherty1@partners.org

Eligibility Criteria

Inclusion Criteria: 1. Glioblastoma Multiforme (GBM) 2. 70 or above on Karnofsky Performance Status 3. Adequate bone marrow function 4. For Arm A, subject has newly diagnosed GBM and prior surgical resection 5. For Arm B, subject has newly diagnosed GBM and has completed adjuvant radiation and/or temozolomide therapy or has recurrent GBM per RANO Criteria Exclusion Criteria: 1. For subjects with newly diagnosed GBM, subject has received prior chemotherapy or radiotherapy for cancer of head and neck region 2. For Subjects with recurrent GBM in Arm B, subject has received prior treatment with bevacizumab, nitrosourea, more than 2 therapies, or has secondary GBM 3. Allergies to temozolomide, dacarbazine, IgG containing agents 4. Anti-cancer treatment 28 days prior to study Day 1
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