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ANG1005 in Leptomeningeal Disease From Breast Cancer (ANGLeD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03613181
Recruitment Status : Not yet recruiting
First Posted : August 3, 2018
Last Update Posted : September 10, 2021
Information provided by (Responsible Party):
Angiochem Inc

Brief 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.

Condition or disease Intervention/treatment Phase
Leptomeningeal Carcinomatosis Leptomeningeal Metastases Brain Metastases HER2-negative Breast Cancer Drug: ANG1005 Drug: Physician's Best Choice Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 1:1 randomization to experimental arm and comparator arm
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Estimated Study Start Date : December 2021
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : March 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: ANG1005
ANG1005 Investigational Drug
Drug: ANG1005
Investigational drug
Other Name: paclitaxel trevatide

Active Comparator: Physician's Best Choice
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.
Drug: Physician's Best Choice
Active Comparator: one of 3 pre-determined choices of therapies: capecitabine or eribulin or high-dose IV methotrexate.
Other Names:
  • capecitabine
  • eribulin
  • high-dose IV methotrexate.

Primary Outcome Measures :
  1. Overall survival [ Time Frame: From the date of randomization until death due to any cause, assessed for up to 2 years. ]

Secondary Outcome Measures :
  1. Central nervous system progression-free survival [ Time Frame: From the date of randomization until central nervous system progression, assessed for up to 2 years. ]
  2. Central nervous system clinical benefit rate at 3, 6 and 12 months [ Time Frame: At 3, 6 and 12 months. ]
  3. 6-month and 12-month overall survival rates [ Time Frame: At 6 and 12 months. ]
  4. Leptomeningeal carcinomatosis response rate [ Time Frame: Assessed for up to 2 years from first patient randomised. ]
  5. Duration of leptomeningeal carcinomatosis response [ Time Frame: Assessed for up to 2 years from first patient randomised. ]
  6. 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. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. ≥ 18 years old
  2. HER2-negative breast cancer
  3. At least 2 months of expected survival
  4. Newly diagnosed leptomeningeal carcinomatosis
  5. Documented history of brain metastasis that has been previously treated with radiation therapy
  6. Neurologically stable
  7. Eastern Cooperative Oncology Group performance status grade ≤2
  8. Adequate laboratory test results prior to first dose
  9. Patients who are fertile must agree to remain abstinent or use reliable method of birth control

Exclusion Criteria:

  1. Any prior treatment for leptomeningeal carcinomatosis, except emergency radiotherapy or shunt
  2. Prior treatment with ANG1005
  3. Patients who have not had radiotherapy for their brain metastases
  4. Evidence of symptomatic intracranial hemorrhage or increased intracranial pressure
  5. Patients for whom intrathecal therapy is the most appropriate therapy for leptomeningeal disease
  6. Pregnancy or lactation and patients planning to be pregnant during the study
  7. Peripheral neuropathy > Grade 2
  8. Evidence of severe or uncontrolled diseases
  9. Presence of an infection including abscess or fistulae, or known infection with hepatitis B or C or HIV
  10. History of interstitial lung disease
  11. Severe conduction disturbance
  12. Central nervous system disease requiring immediate neurosurgical intervention
  13. Known allergy to paclitaxel or any of its components
  14. Contra-indication for contrast-enhanced MRI

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03613181

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Contact: Vihra Iordanova +1 514 788 7800 ext 106
Contact: Betty Lawrence +1 514 788 7800 ext 103

Sponsors and Collaborators
Angiochem Inc
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Study Director: Betty Lawrence Angiochem Inc
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Responsible Party: Angiochem Inc Identifier: NCT03613181    
Other Study ID Numbers: ANG1005-CLN-07
First Posted: August 3, 2018    Key Record Dates
Last Update Posted: September 10, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Angiochem Inc:
Leptomeningeal carcinomatosis
Leptomeningeal disease
Leptomeningeal metastases
Brain metastases
Breast cancer
Targeted therapy
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Brain Neoplasms
Meningeal Carcinomatosis
Neoplasms by Site
Breast Diseases
Skin Diseases
Neoplastic Processes
Pathologic Processes
Central Nervous System Neoplasms
Nervous System Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Meningeal Neoplasms
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic