Back to resultsExpanded 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
About this trial
This is an expanded access trial for Anaplastic Astrocytoma
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
Sites / Locations
- UC Irvine Health
- Univeristy of Texas Health Science Center in San Antonio
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
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
We'll reach out to this number within 24 hrs