ANG1005 in Patients With Recurrent High-Grade Glioma

Glioblastoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01967810
• Other study ID #: ANG1005-CLN-03
• Status: Completed
• Phase: Phase 2
• Start date: October 2013
• Est. completion date: September 2017

Study information

• Verified date: February 2020
• Source: Angiochem Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

See above.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: September 2017
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Neoplasms
• Brain Tumor, Recurrent
• Glioblastoma
• Glioma

Intervention

Drug:
• ANG1005
ANG1005 at a starting dose of 650 mg/m^2 or 600 mg/m^2 by intravenous infusion once every 3 weeks
• 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.

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Emily Couric Clinical Cancer Center	Charlottesville	Virginia
United States	Northwestern University	Chicago	Illinois
United States	Cleveland Clinic	Cleveland	Ohio
United States	Moores UC San Diego Cancer Center	La Jolla	California
United States	Norris Cotton Cancer Center	Lebanon	New Hampshire
United States	UPMC Cancer Center	Pittsburgh	Pennsylvania
United States	Univeristy of Texas Health Science Center in San Antonio	San Antonio	Texas
United States	Seattle Cancer Care Alliance	Seattle	Washington
United States	University of Washington Medical Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Angiochem Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Upon enrollment through end of study period (1 year after last patient is enrolled)
Primary	PFS3 (Arm 2)	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	ORR in Arm 2	To determine the ORR in Arm 2	Upon enrollment through end of study period (1 year after last patient is enrolled)
Secondary	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	Upon enrollment through end of study period (1 year after last patient is enrolled)
Secondary	Median PFS	To determine the median progression-free survival in each arm	Upon enrollment through end of study period (1 year after last patient is enrolled)
Secondary	Duration of response	To determine the median duration of response in each arm	Upon enrollment through end of study period (1 year after last patient is enrolled)
Secondary	Overall survival	To determine the median overall survival in each arm	Upon enrollment through end of study period (1 year after last patient is enrolled)
Secondary	Safety and tolerability	To determine the number of participants with adverse events	Upon enrollment through end of study period (1 year after last patient is enrolled)
Secondary	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)	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)

External Links

•   A Phase I sudy of ANG1005 (GRN1005) in recurrent malignant glioma