Leptomeningeal CarcinomatosisPhase 3ANGLeDNCT03613181
ANG1005 in Leptomeningeal Disease From Breast Cancer
A Phase 3 study testing ANG1005 and Physician's Best Choice in people with Leptomeningeal Carcinomatosis and Leptomeningeal Metastases, run by Angiochem Inc.
Trial summary
This is an open-label Phase 3 study to see if ANG1005 can prolong survival compared to a Physician Best Choice control in HER2-negative breast cancer patients with newly diagnosed leptomeningeal disease and previously treated brain metastases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leptomeningeal Carcinomatosis, Leptomeningeal Metastases, Brain Metastases
- What is being tested?
- ANG1005 and Physician's Best Choice
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Dec 2023to Dec 2024
- Phase
- Phase 3
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 18 years old
- HER2-negative breast cancer
- At least 2 months of expected survival
- Newly diagnosed leptomeningeal carcinomatosis
- Documented history of brain metastasis that has been previously treated with radiation therapy
- Neurologically stable
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- Eastern Cooperative Oncology Group performance status grade ≤2
- Adequate laboratory test results prior to first dose
- Patients who are fertile must agree to remain abstinent or use reliable method of birth control
Who cannot join
- Any prior treatment for leptomeningeal carcinomatosis, except emergency radiotherapy or shunt
- Prior treatment with ANG1005
- Patients who have not had radiotherapy for their brain metastases
- Evidence of symptomatic intracranial hemorrhage or increased intracranial pressure
- Patients for whom intrathecal therapy is the most appropriate therapy for leptomeningeal disease
- Pregnancy or lactation and patients planning to be pregnant during the study
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- Peripheral neuropathy > Grade 2
- Evidence of severe or uncontrolled diseases
- Presence of an infection including abscess or fistulae, or known infection with hepatitis B or C or HIV
- History of interstitial lung disease
- Severe conduction disturbance
- Central nervous system disease requiring immediate neurosurgical intervention
- Known allergy to paclitaxel or any of its components
- Contra-indication for contrast-enhanced MRI
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Randomized Open-Label, Multi-Center Pivotal Study of ANG1005 Compared With Physician's Best Choice in HER2-Negative Breast Cancer Patients With Newly Diagnosed Leptomeningeal Carcinomatosis and Previously Treated Brain Metastases (ANGLeD)
This is an open-label Phase 3 study to see if ANG1005 can prolong survival compared to a Physician Best Choice control in HER2-negative breast cancer patients with newly diagnosed leptomeningeal disease and previously treated brain metastases.
- Conditions
- Leptomeningeal Carcinomatosis, Leptomeningeal Metastases, Brain Metastases, HER2-negative Breast Cancer
- Being tested
- ANG1005, Physician's Best Choice
- Keywords
- ANG1005, Leptomeningeal carcinomatosis, Leptomeningeal disease, Leptomeningeal metastases, Brain metastases, HER2-negative, Breast cancer, Targeted therapy
- Medical subject headings
- Meningeal Carcinomatosis, Brain Neoplasms, Meningeal Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ANG1005Drug
Also called paclitaxel trevatide
Investigational drug
Physician's Best ChoiceDrug
Also called capecitabine, eribulin, high-dose IV methotrexate.
Active Comparator: one of 3 pre-determined choices of therapies: capecitabine or eribulin or high-dose IV methotrexate.
| Study group | Role | What they receive |
|---|---|---|
| ANG1005 | Experimental | ANG1005 Investigational Drug Receives: Drug: ANG1005 |
| Physician's Best Choice | Active comparator | One of the protocol specified Physician's Best Choice therapies, assigned by the Investigator prior to randomization: capecitabine or eribulin or high-dose intravenous (IV) methotrexate. Receives: Drug: Physician's Best Choice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: From the date of randomization until death due to any cause, assessed for up to 2 years.
Secondary outcomes (6)
Central nervous system progression-free survival
Measured: From the date of randomization until central nervous system progression, assessed for up to 2 years.
Central nervous system clinical benefit rate at 3, 6 and 12 months
Measured: At 3, 6 and 12 months.
6-month and 12-month overall survival rates
Measured: At 6 and 12 months.
Leptomeningeal carcinomatosis response rate
Measured: Assessed for up to 2 years from first patient randomised.
Duration of leptomeningeal carcinomatosis response
Measured: Assessed for up to 2 years from first patient randomised.
Overall survival in triple negative breast cancer patients
Measured: From the date of randomization until death due to any cause, assessed for up to 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2018
- Study startDec 2023 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leptomeningeal CarcinomatosisStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:1 randomization to experimental arm and comparator arm
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Angiochem Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03613181
- Sponsor's protocol ID
- ANG1005-CLN-07
- Acronym
- ANGLeD
- Status last verified
- Apr 2023
- First submitted
- 17 Jul 2018
- Last updated
- 24 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Open-Label, Multi-Center Pivotal Study of ANG1005 Compared With Physician's Best Choice in HER2-Negative Breast Cancer Patients With Newly Diagnosed Leptomeningeal Carcinomatosis and Previously Treated Brain Metastases (ANGLeD)
- ClinicalTrials.gov ID
- NCT03613181
- Acronym / sponsor ID
- ANGLeD / ANG1005-CLN-07
- Conditions
- Leptomeningeal Carcinomatosis, Leptomeningeal Metastases, Brain Metastases, HER2-negative Breast Cancer
- Keywords
- ANG1005, Leptomeningeal carcinomatosis, Leptomeningeal disease, Leptomeningeal metastases, Brain metastases, HER2-negative, Breast cancer, Targeted therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Angiochem IncIndustry (pharma, biotech, devices)
- Study start
- Dec 2023 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 3 Aug 2018 (actual)
- 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 open-label Phase 3 study to see if ANG1005 can prolong survival compared to a Physician Best Choice control in HER2-negative breast cancer patients with newly diagnosed leptomeningeal disease and previously treated brain metastases.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 1:1 randomization to experimental arm and comparator arm
| Arm | Type | Receives |
|---|---|---|
| ANG1005 | Experimental | Drug: ANG1005ANG1005 Investigational Drug |
| Physician's Best Choice | Active comparator | Drug: Physician's Best ChoiceOne of the protocol specified Physician's Best Choice therapies, assigned by the Investigator prior to randomization: capecitabine or eribulin or high-dose intravenous (IV) methotrexate. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- ≥ 18 years old
- HER2-negative breast cancer
- At least 2 months of expected survival
- Newly diagnosed leptomeningeal carcinomatosis
- Documented history of brain metastasis that has been previously treated with radiation therapy
Key exclusion criteria (14 listed)
- Any prior treatment for leptomeningeal carcinomatosis, except emergency radiotherapy or shunt
- Prior treatment with ANG1005
- Patients who have not had radiotherapy for their brain metastases
- Evidence of symptomatic intracranial hemorrhage or increased intracranial pressure
- Patients for whom intrathecal therapy is the most appropriate therapy for leptomeningeal 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 |
|---|---|---|
| ANG1005Also: paclitaxel trevatideInvestigational drug | Drug | ANG1005 |
| Physician's Best ChoiceAlso: capecitabine, eribulin, high-dose IV methotrexate.Active Comparator: one of 3 pre-determined choices of therapies: capecitabine or eribulin or high-dose IV methotrexate. | Drug | Physician's Best Choice |
Primary outcome
Overall survival
Time frame: From the date of randomization until death due to any cause, assessed for up to 2 years.
6 secondary outcomes
Central nervous system progression-free survival
Time frame: From the date of randomization until central nervous system progression, assessed for up to 2 years.
Central nervous system clinical benefit rate at 3, 6 and 12 months
Time frame: At 3, 6 and 12 months.
6-month and 12-month overall survival rates
Time frame: At 6 and 12 months.
Leptomeningeal carcinomatosis response rate
Time frame: Assessed for up to 2 years from first patient randomised.
Duration of leptomeningeal carcinomatosis response
Time frame: Assessed for up to 2 years from first patient randomised.
Overall survival in triple negative breast cancer patients
Time frame: From the date of randomization until death due to any cause, assessed for up to 2 years.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2023.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ANG1005 and Physician's Best Choice in people with Leptomeningeal Carcinomatosis and Leptomeningeal Metastases, run by Angiochem Inc.
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 9 inclusion and 14 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 24 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact John Huss (1-514-788-7800, jhuss@angiochem.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: From the date of randomization until death due to any cause, assessed for up to 2 years.). It is what the study was designed to measure, not a finding.
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 24 Apr 2023.