Expanded Access to ANG1005 for Individual Patients

NCT ID: NCT02755987

Last Updated: 2016-06-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NO_LONGER_AVAILABLE

Study Classification

EXPANDED_ACCESS

Brief Summary

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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

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Conditions

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Anaplastic Astrocytoma Anaplastic Oligodendroglioma Breast Cancer With Recurrent Brain Metastases Leptomeningeal Carcinomatosis

Interventions

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ANG1005

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Angiochem Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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UC Irvine Health

Orange, California, United States

Site Status

Univeristy of Texas Health Science Center in San Antonio

San Antonio, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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

Identifier Type: -

Identifier Source: org_study_id

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