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NCT02755987 Clinical Trial

Expanded Access to ANG1005 for Individual Patients

Anaplastic Astrocytoma Clinical Trial

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.

Clinical Trial Details — Status: No longer available

Administrative data
NCT number NCT02755987
Other study ID # ANG1005-EAP-01, EAP-02, EAP-03
Secondary ID
Status No longer available
Phase N/A
First received April 27, 2016
Last updated June 3, 2016

Study information
Verified date June 2016
Source Angiochem Inc
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Expanded Access

Clinical Trial 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.

Recruitment information / eligibility
Status No longer available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender Female
Age group 18 Years and older
Eligibility 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

N/A

Related Conditions & MeSH terms

Intervention

Drug:
• ANG1005

Locations
Country Name City State
United States UC Irvine Health Orange California
United States Univeristy of Texas Health Science Center in San Antonio San Antonio Texas

Sponsors (1)
Lead Sponsor Collaborator
Angiochem Inc

Country where clinical trial is conducted

United States, 

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