ANG1005 in Patients With Recurrent High-Grade Glioma

February 19, 2020 updated by: Angiochem Inc

A Phase II, Open-Label, Multi-Center Study of ANG1005 in Patients With Recurrent High-Grade Glioma

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

See above.

Study Type

Interventional

Enrollment (Actual)

73

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92093-0698
        • Moores UC San Diego Cancer Center
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02215
        • Dana Farber Cancer Institute
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Norris Cotton Cancer Center
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15323
        • UPMC Cancer Center
    • Texas
      • San Antonio, Texas, United States, 78229
        • Univeristy of Texas Health Science Center in San Antonio
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • Emily Couric Clinical Cancer Center
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington Medical Center
      • Seattle, Washington, United States, 98109-1023
        • Seattle Cancer Care Alliance

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • GRN1005

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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)
To determine the progression-free survival at 3 months (PFS3) in bevacizumab-refractory recurrent GBM patients (Arm 2)
Upon enrollment through end of study period (1 year after last patient is enrolled)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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)
  • 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
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)
To determine the median progression-free survival in each arm
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)
To determine the median duration of response in each arm
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)
To determine the median overall survival in each arm
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)
To determine the number of participants with adverse events
Upon enrollment through end of study period (1 year after last patient is enrolled)
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)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Angiochem Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (ACTUAL)

February 1, 2016

Study Completion (ACTUAL)

September 1, 2017

Study Registration Dates

First Submitted

October 9, 2013

First Submitted That Met QC Criteria

October 18, 2013

First Posted (ESTIMATE)

October 23, 2013

Study Record Updates

Last Update Posted (ACTUAL)

February 25, 2020

Last Update Submitted That Met QC Criteria

February 19, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANG1005-CLN-03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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