Expanded Access to ANG1005 for Individual Patients
1 other identifier
expanded_access
N/A
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
2 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 27, 2016
CompletedFirst Posted
Study publicly available on registry
April 29, 2016
CompletedJune 7, 2016
June 1, 2016
April 27, 2016
June 3, 2016
Conditions
Interventions
Eligibility Criteria
You may qualify if:
- Neurologically stable
- Karnofsky performance status (KPS) ≥ 80
- Adequate laboratory results
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Angiochem Inclead
Study Sites (2)
UC Irvine Health
Orange, California, 92868, United States
Univeristy of Texas Health Science Center in San Antonio
San Antonio, Texas, 78229, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- expanded access
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 27, 2016
First Posted
April 29, 2016
Last Updated
June 7, 2016
Record last verified: 2016-06