Expanded Access to ANG1005 for Individual Patients

Sponsor

Angiochem Inc (Industry)

Overall Status

No longer available

CT.gov ID

NCT02755987

Collaborator

(none)

Locations

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anaplastic Astrocytoma Anaplastic Oligodendroglioma Breast Cancer With Recurrent Brain Metastases Leptomeningeal Carcinomatosis	Drug: ANG1005

Study Design

Study Type:

Expanded Access

Official Title:

Expanded Access to ANG1005 for an Individual Patient With Recurrent WHO Grade III Anaplastic Astrocytoma; Expanded Access to ANG1005 for an Individual Patient With Recurrent WHO Grade III Anaplastic Oligodendroglioma; Expanded Access to ANG1005 for an Individual Breast Cancer Patient With Recurrent Brain Metastases and Leptomeningeal Carcinomatosis.

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Inclusion Criteria:

Neurologically stable
Karnofsky performance status (KPS) ≥ 80
Adequate laboratory results

Exclusion Criteria:

Radiotherapy within 3 months.
Evidence of significant intracranial hemorrhage
NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v4.0 Grade ≥ 2 neuropathy
Inadequate bone marrow reserve
Any evidence of severe or uncontrolled disease