ANG1005 in Breast Cancer Patients With Recurrent Brain Metastases

Angiochem

Status and phase: Completed; Phase 2

Conditions: Breast Cancer; Brain Metastases

Treatments: Drug: ANG1005

Study type: Interventional

Funder types: Industry

Identifiers

NCT02048059

ANG1005-CLN-04

Details and patient eligibility

About

This is a Phase 2 study to see if an investigational drug, ANG1005, can shrink tumor cells in breast cancer patients with recurrent brain metastases.

Enrollment: 72 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. ≥ 18 years old
2. Breast cancer
3. Recurrent brain metastases from breast cancer
4. At least one radiologically-confirmed and measurable metastatic brain lesion ( ≥ 0.5 cm)
5. Neurologically stable
6. Karnofsky Performance Status (KPS) score ≥ 70
7. Adequate hematology and serum chemistry laboratory test results
8. Expected survival of ≥ 3 months

Exclusion criteria

1. Prior treatment with ANG1005/GRN1005
2. Evidence of symptomatic intracranial hemorrhage
3. Pregnancy or lactation
4. Inadequate bone marrow reserve
5. Any evidence of severe or uncontrolled diseases
6. Patients with the presence of an infection including abscess or fistulae, or known infection with hepatitis B or C or HIV
7. History of interstitial lung disease or evidence of clinically significant interstitial lung disease
8. Severe cardiac conduction disturbance
9. Central nervous system (CNS) disease requiring immediate neurosurgery intervention
10. Known severe hypersensitivity or allergy to paclitaxel or any of its components

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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72 participants in 1 patient group

ANG1005

Experimental group

Description:

Participants received ANG1005 intravenously (IV) at a dose of 600 mg/m\^2 on Day 1 of each 21-day cycle. ANG1005 will be administered for up to a maximum of one year, or until disease progression or adverse events (AE) that are not tolerated.

Treatment:

Drug: ANG1005