Glioblastoma Clinical Trial
Official title:
A Phase II, Open-Label, Multi-Center Study of ANG1005 in Patients With Recurrent High-Grade Glioma
Verified date | February 2020 |
Source | Angiochem Inc |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 73 |
Est. completion date | September 2017 |
Est. primary completion date | February 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
United States | Dana Farber Cancer Institute | Boston | Massachusetts |
United States | Massachusetts General Hospital | Boston | Massachusetts |
United States | Emily Couric Clinical Cancer Center | Charlottesville | Virginia |
United States | Northwestern University | Chicago | Illinois |
United States | Cleveland Clinic | Cleveland | Ohio |
United States | Moores UC San Diego Cancer Center | La Jolla | California |
United States | Norris Cotton Cancer Center | Lebanon | New Hampshire |
United States | UPMC Cancer Center | Pittsburgh | Pennsylvania |
United States | Univeristy of Texas Health Science Center in San Antonio | San Antonio | Texas |
United States | Seattle Cancer Care Alliance | Seattle | Washington |
United States | University of Washington Medical Center | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
Angiochem Inc |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Objective Response Rate (ORR) (Arms 1 and 3) | 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) | Upon enrollment through end of study period (1 year after last patient is enrolled) | |
Primary | PFS3 (Arm 2) | To determine the progression-free survival at 3 months (PFS3) in bevacizumab-refractory recurrent GBM patients (Arm 2) | Upon enrollment through end of study period (1 year after last patient is enrolled) | |
Secondary | ORR in Arm 2 | To determine the ORR in Arm 2 | Upon enrollment through end of study period (1 year after last patient is enrolled) | |
Secondary | PFS at 3, 6 and 12 months | 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 |
Upon enrollment through end of study period (1 year after last patient is enrolled) | |
Secondary | Median PFS | To determine the median progression-free survival in each arm | Upon enrollment through end of study period (1 year after last patient is enrolled) | |
Secondary | Duration of response | To determine the median duration of response in each arm | Upon enrollment through end of study period (1 year after last patient is enrolled) | |
Secondary | Overall survival | To determine the median overall survival in each arm | Upon enrollment through end of study period (1 year after last patient is enrolled) | |
Secondary | Safety and tolerability | To determine the number of participants with adverse events | Upon enrollment through end of study period (1 year after last patient is enrolled) | |
Secondary | Plasma Pharmacokinetics of ANG1005 (Half-life [T1/2], Maximum Concentration [Cmax], Area Under the Curve [AUC]) | To determine the drug concentration and distribution in the blood (plasma) | 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) |
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