Anaplastic AstrocytomaNCT02755987
Expanded Access to ANG1005 for Individual Patients
A study testing ANG1005 in people with Anaplastic Astrocytoma and Anaplastic Oligodendroglioma, run by Angiochem Inc at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Anaplastic Astrocytoma, Anaplastic Oligodendroglioma, Breast Cancer With Recurrent Brain Metastases
- What is being tested?
- ANG1005
- How many people
- Not given
- Where
- 2 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Adult, Older adult
Who may be able to join
- Neurologically stable
- Karnofsky performance status (KPS) ≥ 80
- Adequate laboratory results
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UC Irvine Health
Orange, California, 92868
Univeristy of Texas Health Science Center in San Antonio
San Antonio, Texas, 78229
About this study
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.
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.
- Conditions
- Anaplastic Astrocytoma, Anaplastic Oligodendroglioma, Breast Cancer With Recurrent Brain Metastases, Leptomeningeal Carcinomatosis
- Being tested
- ANG1005
- Medical subject headings
- Astrocytoma, Oligodendroglioma, Meningeal Carcinomatosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ANG1005Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anaplastic AstrocytomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Angiochem Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02755987
- Sponsor's protocol ID
- ANG1005-EAP-01, EAP-02, EAP-03
- Status last verified
- Jun 2016
- First submitted
- 27 Apr 2016
- Last updated
- 7 Jun 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02755987
- Acronym / sponsor ID
- ANG1005-EAP-01, EAP-02, EAP-03
- Conditions
- Anaplastic Astrocytoma, Anaplastic Oligodendroglioma, Breast Cancer With Recurrent Brain Metastases, Leptomeningeal Carcinomatosis
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Angiochem IncIndustry (pharma, biotech, devices)
- First posted
- 29 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Neurologically stable
- Karnofsky performance status (KPS) ≥ 80
- Adequate laboratory results
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ANG1005 | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ANG1005 in people with Anaplastic Astrocytoma and Anaplastic Oligodendroglioma, run by Angiochem Inc at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2016.