Expanded Access to ANG1005 for Individual Patients

June 3, 2016 updated by: Angiochem Inc

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.

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.

Study Overview

Status

No longer available

Conditions

Intervention / Treatment

Study Type

Expanded Access

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Orange, California, United States, 92868
        • UC Irvine Health
    • Texas
      • San Antonio, Texas, United States, 78229
        • Univeristy of Texas Health Science Center in San Antonio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Angiochem Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

April 27, 2016

First Submitted That Met QC Criteria

April 27, 2016

First Posted (Estimate)

April 29, 2016

Study Record Updates

Last Update Posted (Estimate)

June 7, 2016

Last Update Submitted That Met QC Criteria

June 3, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANG1005-EAP-01, EAP-02, EAP-03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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