ANG1005 in Patients With Recurrent High-Grade Glioma

Status: Recruiting
Phase: Phase 2
Diagnosis: Brain/Neuro Cancer: Recurrent Glioblastoma
NCT ID: NCT01967810 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 13-509

 

This is a Phase 2 study to see if an investigational drug, ANG1005, can shrink tumor cells in patients with high-grade glioma. Another purpose of this study is to assess the efficacy, safety, tolerability, and pharmacokinetics (PK) of ANG1005 in patients.

 

Conducting Institutions:
Dana-Farber Cancer Institute, Brigham and Women's Hospital, Massachusetts General Hospital, Beth-Israel Deaconess Medical Center

Overall PI:
Patrick Wen, MD, Dana-Farber Cancer Institute

Site-responsible Investigators:

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

Eligibility Criteria

Inclusion Criteria: 1. ≥ 18 years old 2. GBM and GBM variants, WHO Grade III anaplastic glioma diagnosis confirmed 3. Radiologically confirmed recurrent and bi-dimensionally measurable disease per Response Assessment in Neuro-Oncology (RANO) criteria 4. Neurologically stable 5. For bevacizumab-refractory patients, radiologic demonstration of tumor progression during bevacizumab therapy 6. Karnofsky performance status (KPS) ≥ 70 Exclusion Criteria: 1. More than three relapses 2. Previous ANG1005/GRN1005 treatment 3. Radiotherapy within 3 months. 4. Therapy with bevacizumab within 4 weeks prior to screening for recurrent WHO grade III anaplastic glioma patients (Arm 3) 5. Evidence of significant intracranial hemorrhage 6. Previous taxane treatment 7. Prior therapy with bevacizumab for bevacizumab-naïve patients (Arm 1) 8. NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v4.0 Grade ≥ 2 neuropathy 9. Inadequate bone marrow reserve
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