ANG1005 in Patients With Recurrent High-Grade Glioma

Status:	Completed
Conditions:	Brain Cancer, Brain Cancer, Brain Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	9/30/2017
Start Date:	October 2013
End Date:	September 2017

A Phase II, Open-Label, Multi-Center Study of ANG1005 in Patients With Recurrent High-Grade Glioma

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.

See above.

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

We found this trial at

sites

University of Washington Medical Center

1959 NE Pacific St
Seattle, Washington 98195

(206) 598-3300