ANG1005 in Breast Cancer Patients With Recurrent Brain Metastases

Phase 2CompletedNCT02048059

Angiochem Inc72 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Breast Cancer Brain Metastases

Interventions

ANG1005DRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (19)

University of Arizona Cancer Center

Tucson, Arizona, United States

Outcomes

Primary Outcomes

Intracranial objective response rate (iORR)

Time frame: Upon enrollment through end of study period (1 year after last patient is enrolled)

Secondary Outcomes

Duration of intracranial objective response

Time frame: Upon enrollment through end of study period (1 year after last patient is enrolled)

Median intracranial progression-free survival (PFS)

Time frame: Upon enrollment through end of study period (1 year after last patient is enrolled)

Intracranial PFS rates at 3, 6 and 12 months

Time frame: Upon enrollment through end of study period (1 year after last patient is enrolled)

6-month overall survival (OS) rate

Time frame: Upon enrollment through end of study period (1 year after last patient is enrolled

Extracranial objective response rate (eORR) and duration of response

Time frame: Upon enrollment through end of study period (1 year after last patient is enrolled

Number of Patients with adverse events

Time frame: Upon enrollment through end of study period (1 year after last patient is enrolled

Plasma pharmacokinetics of ANG1005

To determine the drug concentration and distribution in the plasma. (AUC, Cmax, T1/2)

Time frame: On Day 1 of Cycles 1 and 3

Intracranial ORR by modified Response Assessment in Neuro-Oncology (RANO) criteria

Time frame: Upon enrollment through end of study period (1 year after last patient is enrolled)

Data from ClinicalTrials.gov

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