Expanded Access to ANG1005 for Individual Patients

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

• Registration Number: NCT02755987
• Lead Sponsor: Angiochem Inc

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-04-27
• Study First Submitted QC: 2016-04-27
• Study First Posted: 2016-04-29
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-03
• Last Update Posted: 2016-06-07

Recruitment & Eligibility

• Status: NO_LONGER_AVAILABLE
• Sex: Female
• Target Recruitment: Not specified

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

Study & Design

• Study Type: EXPANDED_ACCESS
• Study Design: Not specified

Trial Locations

Locations (2)

UC Irvine Health; 🇺🇸 Orange, California, United States

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