ANG1005 in Patients With Recurrent High-Grade Glioma

Completed · Phase 2

Conditions studied: Glioma, Glioblastoma, Brain Tumor, Recurrent

In brief

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.

Key facts

Study ID

NCT01967810

Run by

Angiochem Inc

People needed

73

Starts

2013-10-01

Expected to finish

2017-09-01

Last updated by the study team

2020-02-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥ 18 years old
• GBM and GBM variants, WHO Grade III anaplastic glioma diagnosis confirmed
• Radiologically confirmed recurrent and bi-dimensionally measurable disease per Response Assessment in Neuro-Oncology (RANO) criteria
• Neurologically stable
• For bevacizumab-refractory patients, radiologic demonstration of tumor progression during bevacizumab therapy
• Karnofsky performance status (KPS) ≥ 80
• Expected survival of at least 3 months

You may not qualify if…

• More than three relapses
• Previous ANG1005/GRN1005 treatment
• Radiotherapy within 3 months.
• Therapy with bevacizumab within 4 weeks prior to Day 1 of treatment for recurrent WHO grade III anaplastic glioma patients (Arm 3)
• Evidence of significant intracranial hemorrhage
• Previous taxane treatment
• Prior therapy with bevacizumab for bevacizumab-naïve patients (Arm 1)
• NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v4.0 Grade ≥ 2 neuropathy
• Inadequate bone marrow reserve
• Any evidence of severe or uncontrolled diseases
• Participants with the presence of an infection including abscess or fistulae, or known infection with hepatitis C or B or HIV
• Known severe hypersensitivity or allergy to paclitaxel or any of its components

Where it is running

• Moores UC San Diego Cancer Center — La Jolla, California, United States
• Northwestern University — Chicago, Illinois, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Norris Cotton Cancer Center — Lebanon, New Hampshire, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• UPMC Cancer Center — Pittsburgh, Pennsylvania, United States
• Univeristy of Texas Health Science Center in San Antonio — San Antonio, Texas, United States
• Emily Couric Clinical Cancer Center — Charlottesville, Virginia, United States
• Seattle Cancer Care Alliance — Seattle, Washington, United States
• University of Washington Medical Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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