Expanded Access to ANG1005 for Individual Patients | NCT02755987

Studies
Expanded Access to ANG1005 for Individual Patients

NCT02755987

Sponsor

Angiochem Inc

Status

No longer available

Last Update Posted

Jun 7, 2016Estimated

Enrollment

Not provided

Phase

Not provided

Conditions

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

Interventions

ANG1005

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

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.

Status Module

Record Verification Date

Jun 2016

Overall Recruitment Status or Expanded Access Status

No longer available

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Apr 27, 2016

First Submission Date that Met QC Criteria

Apr 27, 2016

First Posted Date

Apr 29, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 3, 2016

Last Update Posted Date

Jun 7, 2016Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Expanded Access

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
ANG1005	Drug

Eligibility Module

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

Accepts Healthy Volunteers

Not provided

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UC Irvine Health		Orange	California	92868	United States
Univeristy of Texas Health Science Center in San Antonio

Condition Browse Module

MeSH Terms

ID	Term
D001254	Astrocytoma
D009837	Oligodendroglioma
D055756	Meningeal Carcinomatosis

Ancestor Terms

ID	Term
D005910	Glioma
D018302	Neoplasms, Neuroepithelial
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal

Browse Leaves

Not provided

Browse Branches

Not provided