ANG1005 in Breast Cancer Patients With Recurrent Brain Metastases

Phase 2

Completed

• Conditions: Breast Cancer; Brain Metastases
• Interventions: Drug: ANG1005

• Registration Number: NCT02048059
• Lead Sponsor: Angiochem Inc

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-01-21
• Study First Submitted QC: 2014-01-27
• Study First Posted: 2014-01-29
• Study Start: 2014-04
• Primary Completion: 2016-03
• Study Completion: 2017-09
• Disposition First Submitted: 2017-09-15
• Disposition First Submitted QC: 2017-09-20
• Disposition First Posted: 2017-09-28
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-19
• Last Update Posted: 2020-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ANG1005	ANG1005	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.

Primary Outcome Measures

Name	Time	Method
Intracranial objective response rate (iORR)	Upon enrollment through end of study period (1 year after last patient is enrolled)

Secondary Outcome Measures

Name	Time	Method
Plasma pharmacokinetics of ANG1005	On Day 1 of Cycles 1 and 3	To determine the drug concentration and distribution in the plasma. (AUC, Cmax, T1/2)
Duration of intracranial objective response	Upon enrollment through end of study period (1 year after last patient is enrolled)
6-month overall survival (OS) rate	Upon enrollment through end of study period (1 year after last patient is enrolled
Extracranial objective response rate (eORR) and duration of response	Upon enrollment through end of study period (1 year after last patient is enrolled
Number of Patients with adverse events	Upon enrollment through end of study period (1 year after last patient is enrolled
Median intracranial progression-free survival (PFS)	Upon enrollment through end of study period (1 year after last patient is enrolled)
Intracranial PFS rates at 3, 6 and 12 months	Upon enrollment through end of study period (1 year after last patient is enrolled)
Intracranial ORR by modified Response Assessment in Neuro-Oncology (RANO) criteria	Upon enrollment through end of study period (1 year after last patient is enrolled)
Intracranial clinical benefit rate (iCBR) at 3 and 6 months	Upon enrollment through end of study period (1 year after last patient is enrolled)
Potential immunogenicity of ANG1005	Upon enrollment through end of study period (1 year after last patient is enrolled)

Trial Locations

Locations (19)

University of California - LAC Medical Center; 🇺🇸 Los Angeles, California, United States

GRU Cancer Center - Georgia Regents University; 🇺🇸 Augusta, Georgia, United States

University of Maryland - Greenebaum Cancer Center; 🇺🇸 Baltimore, Maryland, United States

Northwestern University; 🇺🇸 Chicago, Illinois, United States

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

University of New Mexico; 🇺🇸 Albuquerque, New Mexico, United States

University of Arizona Cancer Center; 🇺🇸 Tucson, Arizona, United States

UC San Diego Moores Cancer Center; 🇺🇸 La Jolla, California, United States

University of Southern California - Norris Comprehensive Cancer Center; 🇺🇸 Los Angeles, California, United States

UC - Irvine Chao Family Comprehensive Cancer Center; 🇺🇸 Orange, California, United States

The Long Islan Brain Tumor Center at Neurological Surgery P.C.; 🇺🇸 Commack, New York, United States

University of Colorado Cancer Center; 🇺🇸 Aurora, Colorado, United States

Magee Womens Hospital; 🇺🇸 Pittsburgh, Pennsylvania, United States

National Cancer Institute; 🇺🇸 Bethesda, Maryland, United States

Cancer & Hematology Centers of Western Michigan; 🇺🇸 Grand Rapids, Michigan, United States

University of North Carolina at Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States

UPMC Cancer Center; 🇺🇸 Pittsburgh, Pennsylvania, United States

Univeristy of Texas Health Science Center in San Antonio; 🇺🇸 San Antonio, Texas, United States