ANG1005 in Patients With Recurrent High-Grade Glioma

Angiochem

Status and phase: Completed; Phase 2

Conditions: Glioblastoma; Glioma; Brain Tumor, Recurrent

Treatments: Drug: ANG1005; Drug: Bevacizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01967810

ANG1005-CLN-03

Details and patient eligibility

About

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.

Full description

See above.

Enrollment: 73 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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73 participants in 3 patient groups

Arm 1

Experimental group

Description:

ANG1005 administered to bevacizumab-naive recurrent GBM participants

Treatment:

Drug: ANG1005

Arm 2

Experimental group

Description:

ANG1005, with or without bevacizumab, administered to bevacizumab-refractory recurrent GBM participants

Treatment:

Drug: Bevacizumab

Drug: ANG1005

Arm 3

Experimental group

Description:

ANG1005 administered to recurrent WHO Grade III anaplastic glioma participants

Treatment:

Drug: ANG1005