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ANG1005 in Patients With Recurrent High-Grade Glioma

Primary Purpose

Glioma, Glioblastoma, Brain Tumor, Recurrent

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ANG1005
Bevacizumab
Sponsored by
Angiochem Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glioma focused on measuring glioma, glioblastoma, brain cancer, brain tumor, recurrent

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Moores UC San Diego Cancer Center
  • Northwestern University
  • Massachusetts General Hospital
  • Beth Israel Deaconess Medical Center
  • Dana Farber Cancer Institute
  • Norris Cotton Cancer Center
  • Cleveland Clinic
  • UPMC Cancer Center
  • Univeristy of Texas Health Science Center in San Antonio
  • Emily Couric Clinical Cancer Center
  • Seattle Cancer Care Alliance
  • University of Washington Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Arm 1

Arm 2

Arm 3

Arm Description

ANG1005 administered to bevacizumab-naive recurrent GBM participants

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

ANG1005 administered to recurrent WHO Grade III anaplastic glioma participants

Outcomes

Primary Outcome Measures

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)
PFS3 (Arm 2)
To determine the progression-free survival at 3 months (PFS3) in bevacizumab-refractory recurrent GBM patients (Arm 2)

Secondary Outcome Measures

ORR in Arm 2
To determine the ORR in Arm 2
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
Median PFS
To determine the median progression-free survival in each arm
Duration of response
To determine the median duration of response in each arm
Overall survival
To determine the median overall survival in each arm
Safety and tolerability
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])
To determine the drug concentration and distribution in the blood (plasma)

Full Information

First Posted
October 9, 2013
Last Updated
February 19, 2020
Sponsor
Angiochem Inc
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1. Study Identification

Unique Protocol Identification Number
NCT01967810
Brief Title
ANG1005 in Patients With Recurrent High-Grade Glioma
Official Title
A Phase II, Open-Label, Multi-Center Study of ANG1005 in Patients With Recurrent High-Grade Glioma
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
September 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Angiochem Inc

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
See above.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioma, Glioblastoma, Brain Tumor, Recurrent
Keywords
glioma, glioblastoma, brain cancer, brain tumor, recurrent

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
73 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Description
ANG1005 administered to bevacizumab-naive recurrent GBM participants
Arm Title
Arm 2
Arm Type
Experimental
Arm Description
ANG1005, with or without bevacizumab, administered to bevacizumab-refractory recurrent GBM participants
Arm Title
Arm 3
Arm Type
Experimental
Arm Description
ANG1005 administered to recurrent WHO Grade III anaplastic glioma participants
Intervention Type
Drug
Intervention Name(s)
ANG1005
Other Intervention Name(s)
GRN1005
Intervention Description
ANG1005 at a starting dose of 650 mg/m^2 or 600 mg/m^2 by intravenous infusion once every 3 weeks
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
Avastin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Objective Response Rate (ORR) (Arms 1 and 3)
Description
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)
Time Frame
Upon enrollment through end of study period (1 year after last patient is enrolled)
Title
PFS3 (Arm 2)
Description
To determine the progression-free survival at 3 months (PFS3) in bevacizumab-refractory recurrent GBM patients (Arm 2)
Time Frame
Upon enrollment through end of study period (1 year after last patient is enrolled)
Secondary Outcome Measure Information:
Title
ORR in Arm 2
Description
To determine the ORR in Arm 2
Time Frame
Upon enrollment through end of study period (1 year after last patient is enrolled)
Title
PFS at 3, 6 and 12 months
Description
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
Time Frame
Upon enrollment through end of study period (1 year after last patient is enrolled)
Title
Median PFS
Description
To determine the median progression-free survival in each arm
Time Frame
Upon enrollment through end of study period (1 year after last patient is enrolled)
Title
Duration of response
Description
To determine the median duration of response in each arm
Time Frame
Upon enrollment through end of study period (1 year after last patient is enrolled)
Title
Overall survival
Description
To determine the median overall survival in each arm
Time Frame
Upon enrollment through end of study period (1 year after last patient is enrolled)
Title
Safety and tolerability
Description
To determine the number of participants with adverse events
Time Frame
Upon enrollment through end of study period (1 year after last patient is enrolled)
Title
Plasma Pharmacokinetics of ANG1005 (Half-life [T1/2], Maximum Concentration [Cmax], Area Under the Curve [AUC])
Description
To determine the drug concentration and distribution in the blood (plasma)
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Betty Lawrence
Organizational Affiliation
Angiochem Inc
Official's Role
Study Director
Facility Information:
Facility Name
Moores UC San Diego Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093-0698
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Norris Cotton Cancer Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
UPMC Cancer Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15323
Country
United States
Facility Name
Univeristy of Texas Health Science Center in San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Emily Couric Clinical Cancer Center
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Facility Name
Seattle Cancer Care Alliance
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109-1023
Country
United States
Facility Name
University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/23349317
Description
A Phase I sudy of ANG1005 (GRN1005) in recurrent malignant glioma

Learn more about this trial

ANG1005 in Patients With Recurrent High-Grade Glioma

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