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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
Sponsor:
Information provided by (Responsible Party):
Angiochem Inc

Study Description
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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.

Condition or disease Intervention/treatment Phase
Glioma Glioblastoma Brain Tumor, Recurrent Drug: ANG1005 Drug: Bevacizumab Phase 2

Detailed Description:
See above.
Study Design
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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

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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)

  2. 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)


Secondary Outcome Measures :
  1. 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

  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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
Angiochem Inc
Investigators
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Study Director: Betty Lawrence Angiochem Inc
More Information
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Additional Information:

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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
Keywords provided by Angiochem Inc:
glioma
glioblastoma
brain cancer
brain tumor
recurrent
Additional relevant MeSH terms:
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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