ANG1005 in Patients With Recurrent High-Grade Glioma
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01967810 |
Recruitment Status :
Completed
First Posted : October 23, 2013
Last Update Posted : February 25, 2020
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Glioma Glioblastoma Brain Tumor, Recurrent | Drug: ANG1005 Drug: Bevacizumab | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 73 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase II, Open-Label, Multi-Center Study of ANG1005 in Patients With Recurrent High-Grade Glioma |
Study Start Date : | October 2013 |
Actual Primary Completion Date : | February 2016 |
Actual Study Completion Date : | September 2017 |

Arm | Intervention/treatment |
---|---|
Experimental: Arm 1
ANG1005 administered to bevacizumab-naive recurrent GBM participants
|
Drug: ANG1005
ANG1005 at a starting dose of 650 mg/m^2 or 600 mg/m^2 by intravenous infusion once every 3 weeks
Other Name: GRN1005 |
Experimental: Arm 2
ANG1005, with or without bevacizumab, administered to bevacizumab-refractory recurrent GBM participants
|
Drug: ANG1005
ANG1005 at a starting dose of 650 mg/m^2 or 600 mg/m^2 by intravenous infusion once every 3 weeks
Other Name: GRN1005 Drug: Bevacizumab 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.
Other Name: Avastin |
Experimental: Arm 3
ANG1005 administered to recurrent WHO Grade III anaplastic glioma participants
|
Drug: ANG1005
ANG1005 at a starting dose of 650 mg/m^2 or 600 mg/m^2 by intravenous infusion once every 3 weeks
Other Name: GRN1005 |
- Objective Response Rate (ORR) (Arms 1 and 3) [ Time Frame: 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) [ Time Frame: 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)
- ORR in Arm 2 [ Time Frame: Upon enrollment through end of study period (1 year after last patient is enrolled) ]To determine the ORR in Arm 2
- PFS at 3, 6 and 12 months [ Time Frame: 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
- Median PFS [ Time Frame: 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 [ Time Frame: Upon enrollment through end of study period (1 year after last patient is enrolled) ]To determine the median duration of response in each arm
- Overall survival [ Time Frame: Upon enrollment through end of study period (1 year after last patient is enrolled) ]To determine the median overall survival in each arm
- Safety and tolerability [ Time Frame: 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]) [ 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) ]To determine the drug concentration and distribution in the blood (plasma)

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- ≥ 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
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01967810
United States, California | |
Moores UC San Diego Cancer Center | |
La Jolla, California, United States, 92093-0698 | |
United States, Illinois | |
Northwestern University | |
Chicago, Illinois, United States, 60611 | |
United States, Massachusetts | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 | |
Beth Israel Deaconess Medical Center | |
Boston, Massachusetts, United States, 02215 | |
Dana Farber Cancer Institute | |
Boston, Massachusetts, United States, 02215 | |
United States, New Hampshire | |
Norris Cotton Cancer Center | |
Lebanon, New Hampshire, United States, 03756 | |
United States, Ohio | |
Cleveland Clinic | |
Cleveland, Ohio, United States, 44195 | |
United States, Pennsylvania | |
UPMC Cancer Center | |
Pittsburgh, Pennsylvania, United States, 15323 | |
United States, Texas | |
Univeristy of Texas Health Science Center in San Antonio | |
San Antonio, Texas, United States, 78229 | |
United States, Virginia | |
Emily Couric Clinical Cancer Center | |
Charlottesville, Virginia, United States, 22903 | |
United States, Washington | |
Seattle Cancer Care Alliance | |
Seattle, Washington, United States, 98109-1023 | |
University of Washington Medical Center | |
Seattle, Washington, United States, 98195 |
Study Director: | Betty Lawrence | Angiochem Inc |
Responsible Party: | Angiochem Inc |
ClinicalTrials.gov Identifier: | NCT01967810 |
Other Study ID Numbers: |
ANG1005-CLN-03 |
First Posted: | October 23, 2013 Key Record Dates |
Last Update Posted: | February 25, 2020 |
Last Verified: | February 2020 |
glioma glioblastoma brain cancer brain tumor recurrent |
Glioblastoma Glioma Brain Neoplasms Astrocytoma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Central Nervous System Neoplasms Nervous System Neoplasms |
Neoplasms by Site Brain Diseases Central Nervous System Diseases Nervous System Diseases Bevacizumab Antineoplastic Agents, Immunological Antineoplastic Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |