ANG1005 in Patients With Recurrent High-Grade Glioma - Full Text View

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:

Drug Information available for: Bevacizumab

Genetic and Rare Diseases Information Center resources: Glioblastoma Glioma Neuroepithelioma

U.S. FDA Resources

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:	July 2016
Estimated Primary Completion Date:	June 2016 (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 (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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) ≥ 70

Exclusion Criteria:

More than three relapses
Previous ANG1005/GRN1005 treatment
Radiotherapy within 3 months.
Therapy with bevacizumab within 4 weeks prior to screening 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

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

Locations


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


Study Director:	Betty Lawrence	Angiochem Inc

More Information

Additional Information:

A Phase I sudy of ANG1005 (GRN1005) in recurrent malignant glioma This link exits the ClinicalTrials.gov site


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:	January 4, 2016
Health Authority:	United States: Food and Drug Administration

Keywords provided by Angiochem Inc:


glioma glioblastoma brain cancer brain tumor recurrent

Additional relevant MeSH terms:


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 Paclitaxel Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Antineoplastic Agents Antineoplastic Agents, Phytogenic Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 27, 2016