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Expanded Access to ANG1005 for Individual Patients

Primary Purpose

Anaplastic Astrocytoma, Anaplastic Oligodendroglioma, Breast Cancer With Recurrent Brain Metastases

Status
No longer available
Phase
Locations
United States
Study Type
Expanded Access
Intervention
ANG1005
Sponsored by
Angiochem Inc
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Anaplastic Astrocytoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)Female

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

Sites / Locations

  • UC Irvine Health
  • Univeristy of Texas Health Science Center in San Antonio

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
April 27, 2016
Last Updated
June 3, 2016
Sponsor
Angiochem Inc
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1. Study Identification

Unique Protocol Identification Number
NCT02755987
Brief Title
Expanded Access to ANG1005 for Individual Patients
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.
Study Type
Expanded Access

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
No longer available
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Angiochem Inc

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anaplastic Astrocytoma, Anaplastic Oligodendroglioma, Breast Cancer With Recurrent Brain Metastases, Leptomeningeal Carcinomatosis

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
ANG1005

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
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
Facility Information:
Facility Name
UC Irvine Health
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Univeristy of Texas Health Science Center in San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Expanded Access to ANG1005 for Individual Patients

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