NCT02755987

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 27, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 29, 2016

Completed
Last Updated

June 7, 2016

Status Verified

June 1, 2016

First QC Date

April 27, 2016

Last Update Submit

June 3, 2016

Conditions

Interventions

Eligibility Criteria

Age18 Years+
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Neurologically stable
  • Karnofsky performance status (KPS) ≥ 80
  • Adequate laboratory results

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

UC Irvine Health

Orange, California, 92868, United States

Location

Univeristy of Texas Health Science Center in San Antonio

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

AstrocytomaOligodendrogliomaMeningeal Carcinomatosis

Interventions

paclitaxel-Angiopep-2 conjugate

Condition Hierarchy (Ancestors)

GliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueMeningeal NeoplasmsCentral Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNervous System Diseases

Study Design

Study Type
expanded access
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2016

First Posted

April 29, 2016

Last Updated

June 7, 2016

Record last verified: 2016-06

Locations