Overview

This trial is active, not recruiting.

Conditions glioma, glioblastoma, brain tumor, recurrent
Treatments ang1005, bevacizumab
Phase phase 2
Target VEGF
Sponsor Angiochem Inc
Start date October 2013
End date June 2016
Trial size 83 participants
Trial identifier NCT01967810, ANG1005-CLN-03

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
ANG1005 administered to bevacizumab-naive recurrent GBM patients
ang1005 GRN1005
ANG1005 at a starting dose of 650 mg/m2 by intravenous infusion once every 3 weeks
(Experimental)
ANG1005 and possibly bevacizumab administered to bevacizumab-refractory recurrent GBM patients
ang1005 GRN1005
ANG1005 at a starting dose of 650 mg/m2 by intravenous infusion once every 3 weeks
bevacizumab Avastin
For patients enrolled in the bevacizumab-refractory in recurrent GBM (Arm 2), treatments with bevacizumab may be continued and administered every 2 or 3 weeks at the Investigator's discretion.
(Experimental)
ANG1005 administered to recurrent WHO Grade III anaplastic glioma
ang1005 GRN1005
ANG1005 at a starting dose of 650 mg/m2 by intravenous infusion once every 3 weeks

Primary Outcomes

Measure
Objective Response Rate (ORR) (Arms 1 and 3)
time frame: Upon enrollment through end of study period (1 year after last patient is enrolled)
PFS3 (Arm 2)
time frame: Upon enrollment through end of study period (1 year after last patient is enrolled)

Secondary Outcomes

Measure
ORR in Arm 2
time frame: Upon enrollment through end of study period (1 year after last patient is enrolled)
PFS at 3, 6 and 12 months
time frame: Upon enrollment through end of study period (1 year after last patient is enrolled)
Median PFS
time frame: Upon enrollment through end of study period (1 year after last patient is enrolled)
Duration of response
time frame: Upon enrollment through end of study period (1 year after last patient is enrolled)
Overall survival
time frame: Upon enrollment through end of study period (1 year after last patient is enrolled)
Safety and tolerability
time frame: Upon enrollment through end of study period (1 year after last patient is enrolled)
Pharmacokinetics
time frame: 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)

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Phase II, Open-Label, Multi-Center Study of ANG1005 in Patients With Recurrent High-Grade Glioma
Description See above.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Angiochem Inc.