ANG1005 in Patients With Recurrent High-Grade Glioma

Phase 2

Completed

• Conditions: Glioma; Glioblastoma; Brain Tumor, Recurrent
• Interventions: Drug: ANG1005; Drug: Bevacizumab

• Registration Number: NCT01967810
• Lead Sponsor: Angiochem Inc

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.

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-10-09
• Study First Submitted QC: 2013-10-18
• Study First Posted: 2013-10-23
• Primary Completion: 2016-02
• Study Completion: 2017-09
• Disposition First Submitted: 2017-09-15
• Disposition First Submitted QC: 2017-09-20
• Disposition First Posted: 2017-09-28
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-19
• Last Update Posted: 2020-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	ANG1005	ANG1005 administered to bevacizumab-naive recurrent GBM participants
Arm 2	ANG1005	ANG1005, with or without bevacizumab, administered to bevacizumab-refractory recurrent GBM participants
Arm 2	Bevacizumab	ANG1005, with or without bevacizumab, administered to bevacizumab-refractory recurrent GBM participants
Arm 3	ANG1005	ANG1005 administered to recurrent WHO Grade III anaplastic glioma participants

Primary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR) (Arms 1 and 3)	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)
PFS3 (Arm 2)	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)

Secondary Outcome Measures

Name	Time	Method
ORR in Arm 2	Upon enrollment through end of study period (1 year after last patient is enrolled)	To determine the ORR in Arm 2
PFS at 3, 6 and 12 months	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
Median PFS	Upon enrollment through end of study period (1 year after last patient is enrolled)	To determine the median progression-free survival in each arm
Duration of response	Upon enrollment through end of study period (1 year after last patient is enrolled)	To determine the median duration of response in each arm
Overall survival	Upon enrollment through end of study period (1 year after last patient is enrolled)	To determine the median overall survival in each arm
Safety and tolerability	Upon enrollment through end of study period (1 year after last patient is enrolled)	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])	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)

Trial Locations

Locations (12)

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

Norris Cotton Cancer Center; 🇺🇸 Lebanon, New Hampshire, United States

Dana Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

UPMC Cancer Center; 🇺🇸 Pittsburgh, Pennsylvania, United States

Emily Couric Clinical Cancer Center; 🇺🇸 Charlottesville, Virginia, United States

Moores UC San Diego Cancer Center; 🇺🇸 La Jolla, California, United States

Univeristy of Texas Health Science Center in San Antonio; 🇺🇸 San Antonio, Texas, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Northwestern University; 🇺🇸 Chicago, Illinois, United States

University of Washington Medical Center; 🇺🇸 Seattle, Washington, United States

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

Seattle Cancer Care Alliance; 🇺🇸 Seattle, Washington, United States