Overview

Expanded Access to ANG1005 for Individual Patients

Status:
No longer available
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
Female
Summary
This is an expanded access study with ANG1005 treatment for two individual patients from Protocol ANG1005-CLN-03 with WHO Grade III Anaplastic Astrocytoma and WHO Grade III Anaplastic Oligodendroglioma and one individual patient from Protocol ANG1005-CLN-04 with Recurrent Brain Metastases and Leptomeningeal Carcinomatosis.
Details
Lead Sponsor:
Angiochem Inc
Treatments:
Paclitaxel
Criteria
Inclusion Criteria:

1. Neurologically stable

2. Karnofsky performance status (KPS) ≥ 80

3. Adequate laboratory results

Exclusion Criteria:

1. Radiotherapy within 3 months.

2. Evidence of significant intracranial hemorrhage

3. NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v4.0 Grade ≥ 2 neuropathy

4. Inadequate bone marrow reserve

5. Any evidence of severe or uncontrolled disease