Expanded Access to ANG1005 for Individual Patients

Angiochem

Status

Conditions: Leptomeningeal Carcinomatosis; Breast Cancer With Recurrent Brain Metastases; Anaplastic Oligodendroglioma; Anaplastic Astrocytoma

Treatments: Drug: ANG1005

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT02755987

ANG1005-EAP-01, EAP-02, EAP-03

Details and patient eligibility

About

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.

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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