Brain Tumor, Recurrent, Glioblastoma, Glioma
Conditions
Keywords
glioma, glioblastoma, brain cancer, brain tumor, recurrent
Brief summary
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.
Detailed description
See above.
Interventions
DRUGANG1005
ANG1005 at a starting dose of 650 mg/m\^2 or 600 mg/m\^2 by intravenous infusion once every 3 weeks
DRUGBevacizumab
For participants enrolled in the bevacizumab-refractory recurrent GBM arm (Arm 2), treatments with bevacizumab may be continued and administered every 2 or 3 weeks at the Investigator's discretion.
Sponsors
Angiochem Inc
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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) ≥ 80 7. Expected survival of at least 3 months
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 Day 1 of treatment 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 10. Any evidence of severe or uncontrolled diseases 11. Participants with the presence of an infection including abscess or fistulae, or known infection with hepatitis C or B or HIV 12. Known severe hypersensitivity or allergy to paclitaxel or any of its components
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) (Arms 1 and 3) | Upon enrollment through end of study period (1 year after last patient is enrolled) | To determine the radiologic ORR in bevacizumab-naïve recurrent Glioblastoma multiforme (GBM) patients (Arm 1)and in recurrent anaplastic glioma World Health Organization (WHO) Grade III patients (Arm 3) |
| PFS3 (Arm 2) | Upon enrollment through end of study period (1 year after last patient is enrolled) | To determine the progression-free survival at 3 months (PFS3) in bevacizumab-refractory recurrent GBM patients (Arm 2) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Median PFS | Upon enrollment through end of study period (1 year after last patient is enrolled) | To determine the median progression-free survival in each arm |
| Duration of response | Upon enrollment through end of study period (1 year after last patient is enrolled) | To determine the median duration of response in each arm |
| ORR in Arm 2 | Upon enrollment through end of study period (1 year after last patient is enrolled) | To determine the ORR in Arm 2 |
| Safety and tolerability | Upon enrollment through end of study period (1 year after last patient is enrolled) | To determine the number of participants with adverse events |
| Plasma Pharmacokinetics of ANG1005 (Half-life [T1/2], Maximum Concentration [Cmax], Area Under the Curve [AUC]) | At 0 h (pre-dose), at the end of infusion, at 2 and 4 hours post-dose on Day 1 of treatment cycles 1 and 3 (Week 1 and Week 9) | To determine the drug concentration and distribution in the blood (plasma) |
| Overall survival | Upon enrollment through end of study period (1 year after last patient is enrolled) | To determine the median overall survival in each arm |
| PFS at 3, 6 and 12 months | Upon enrollment through end of study period (1 year after last patient is enrolled) | * To determine the number of patients without progression at 3, 6 and 12 months in Arms 1 and 3 * To determine the number of patients without progression at 6 and 12 months in Arm 2 |
Countries
United States
Outcome results
None listed