ANG1005 in Patients With Recurrent High-Grade Glioma

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Angiochem Inc
Sponsor:
Information provided by (Responsible Party):
Angiochem Inc
ClinicalTrials.gov Identifier:
NCT01967810
First received: October 9, 2013
Last updated: June 26, 2014
Last verified: June 2014
  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.


Condition Intervention Phase
Glioma
Glioblastoma
Brain Tumor, Recurrent
Drug: ANG1005
Drug: Bevacizumab
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II, Open-Label, Multi-Center Study of ANG1005 in Patients With Recurrent High-Grade Glioma

Resource links provided by NLM:


Further study details as provided by Angiochem Inc:

Primary Outcome Measures:
  • Objective Response Rate (ORR) (Arms 1 and 3) [ Time Frame: Upon enrollment through end of study period (1 year after last patient is enrolled) ] [ Designated as safety issue: No ]
    To determine the radiologic ORR in bevacizumab-naïve recurrent Glioblastoma multiforme (GBM) patients (Arm 1)and in recurrent anaplastic glioma 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) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Upon enrollment through end of study period (1 year after last patient is enrolled) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    • 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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: Yes ]
    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) ] [ Designated as safety issue: Yes ]
    To determine the number of participants with adverse events

  • Pharmacokinetics [ 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) ] [ Designated as safety issue: No ]
    To determine the drug concentration and distribution in the blood (plasma)


Estimated Enrollment: 83
Study Start Date: October 2013
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
ANG1005 administered to bevacizumab-naive recurrent GBM patients
Drug: ANG1005
ANG1005 at a starting dose of 650 mg/m2 by intravenous infusion once every 3 weeks
Other Name: GRN1005
Experimental: Arm 2
ANG1005 and possibly bevacizumab administered to bevacizumab-refractory recurrent GBM patients
Drug: ANG1005
ANG1005 at a starting dose of 650 mg/m2 by intravenous infusion once every 3 weeks
Other Name: GRN1005
Drug: Bevacizumab
For patients enrolled in the bevacizumab-refractory in recurrent GBM (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
Drug: ANG1005
ANG1005 at a starting dose of 650 mg/m2 by intravenous infusion once every 3 weeks
Other Name: GRN1005

Detailed Description:

See above.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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) ≥ 70

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 screening 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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01967810

Contacts
Contact: Veronica Burdusel, M.Sc. 514-788-7800 ext 206 vburdusel@angiochem.com
Contact: Betty Lawrence 514-788-7800 ext 205 blawrence@angiochem.com

Locations
United States, California
Moores UC San Diego Cancer Center Recruiting
La Jolla, California, United States, 92093-0698
Contact: Joanne Brechlin, MBA, MPH    858-822-5352    jbrechlin@ucsd.edu   
Contact: Bradley Brown    858-822-5377    bdbrown@ucsd.edu   
Principal Investigator: Santosh Kesari, MD, PhD         
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Leanne Fountas    312-695-1342    leanne.fountas@northwestern.edu   
Principal Investigator: Priya Kumthekar, MD         
United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Karly Griffin    617-632-6749    karly_griffin@dfci.harvard.edu   
Principal Investigator: Patrick Wen, MD         
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Janlyn Murphy    617-667-1832    jmurphy7@bidmc.harvard.edu   
Principal Investigator: Patrick Wen, MD         
Sub-Investigator: Eric Wong, MD         
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Edwin Nunez, CCRP    617-643-4395    enunez2@mgh.harvard.edu   
Principal Investigator: Patrick Wen, MD         
Sub-Investigator: Tracy T Batchelor, MD, MPH         
United States, Pennsylvania
UPMC Cancer Center Recruiting
Pittsburgh, Pennsylvania, United States, 15323
Contact: Clare Grzejka, BSN, RN    412-623-4891    grzejkac@upmc.edu   
Contact: Melinda Vargas-Jaffe, BSN, RN    412-235-1320    vargasjaffema@upmc.edu   
Principal Investigator: Jan Drappatz, MD         
United States, Texas
Univeristy of Texas Health Science Center in San Antonio Recruiting
San Antonio, Texas, United States, 78229
Contact: Cherie Noles    210-450-5964    nolesc@uthscsa.edu   
Principal Investigator: Andrew Brenner, MD         
United States, Virginia
Emily Couric Clinical Cancer Center Recruiting
Charlottesville, Virginia, United States, 22903
Contact: Johanna Loomba, BS, CCRC    434-924-5859    jjl4d@virginia.edu   
Contact: Monika Thielen    434-243-9900    Mjt3c@virginia.edu   
Principal Investigator: David Schiff, MD         
United States, Washington
University of Washington Medical Center Recruiting
Seattle, Washington, United States, 98195
Contact: Fereshteh Assadian, RN, CCRP    206-685-5597    fassadia@seattlecca.org   
Principal Investigator: Marc Chamberlain, MD         
Seattle Cancer Care Alliance Recruiting
Seattle, Washington, United States, 98109-1023
Contact: Fereshteh Assadian, RN, MSC., CCRP    206-685-5597    fassadia@seattlecca.org   
Principal Investigator: Marc Chamberlain, MD         
Sponsors and Collaborators
Angiochem Inc
Investigators
Study Director: Jean-Paul Castaigne, MD Angiochem Inc
  More Information

Additional Information:
No publications provided

Responsible Party: Angiochem Inc
ClinicalTrials.gov Identifier: NCT01967810     History of Changes
Other Study ID Numbers: ANG1005-CLN-03
Study First Received: October 9, 2013
Last Updated: June 26, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Angiochem Inc:
glioma
glioblastoma
brain cancer
brain tumor
recurrent

Additional relevant MeSH terms:
Brain Neoplasms
Glioblastoma
Glioma
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Astrocytoma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 28, 2014