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ANG1005 in Patients With Recurrent High-Grade Glioma

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT01967810
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Angiochem Inc
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Betty Lawrence
Principal Investigator Affiliation Angiochem Inc
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Completed
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Glioma, Glioblastoma, Brain Tumor, Recurrent
Study Website: View Trial Website
Additional Details

See above.

Arms & Interventions

Arms

Experimental: Arm 1

ANG1005 administered to bevacizumab-naive recurrent GBM participants

Experimental: Arm 2

ANG1005, with or without bevacizumab, administered to bevacizumab-refractory recurrent GBM participants

Experimental: Arm 3

ANG1005 administered to recurrent WHO Grade III anaplastic glioma participants

Interventions

Drug: - ANG1005

ANG1005 at a starting dose of 650 mg/m^2 or 600 mg/m^2 by intravenous infusion once every 3 weeks

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Moores UC San Diego Cancer Center, La Jolla, California

Status

Address

Moores UC San Diego Cancer Center

La Jolla, California, 92093-0698

Northwestern University, Chicago, Illinois

Status

Address

Northwestern University

Chicago, Illinois, 60611

Massachusetts General Hospital, Boston, Massachusetts

Status

Address

Massachusetts General Hospital

Boston, Massachusetts, 02114

Beth Israel Deaconess Medical Center, Boston, Massachusetts

Status

Address

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215

Dana Farber Cancer Institute, Boston, Massachusetts

Status

Address

Dana Farber Cancer Institute

Boston, Massachusetts, 02215

Norris Cotton Cancer Center, Lebanon, New Hampshire

Status

Address

Norris Cotton Cancer Center

Lebanon, New Hampshire, 03756

Cleveland Clinic, Cleveland, Ohio

Status

Address

Cleveland Clinic

Cleveland, Ohio, 44195

UPMC Cancer Center, Pittsburgh, Pennsylvania

Status

Address

UPMC Cancer Center

Pittsburgh, Pennsylvania, 15323

San Antonio, Texas

Status

Address

Univeristy of Texas Health Science Center in San Antonio

San Antonio, Texas, 78229

Emily Couric Clinical Cancer Center, Charlottesville, Virginia

Status

Address

Emily Couric Clinical Cancer Center

Charlottesville, Virginia, 22903

Seattle Cancer Care Alliance, Seattle, Washington

Status

Address

Seattle Cancer Care Alliance

Seattle, Washington, 98109-1023

University of Washington Medical Center, Seattle, Washington

Status

Address

University of Washington Medical Center

Seattle, Washington, 98195