ANG1005 in Breast Cancer Patients With Recurrent Brain Metastases

A Phase II, Open-Label, Multi-Center Study of ANG1005 in Breast Cancer Patients With Recurrent Brain Metastases

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 Overview

• Status: Completed
• Conditions: Breast Cancer; Brain Metastases
• Intervention / Treatment: Drug: ANG1005

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85719
      • University of Arizona Cancer Center
  • California
    • La Jolla, California, United States, 92093-0698
      • UC San Diego Moores Cancer Center
    • Los Angeles, California, United States, 90033
      • University of California - LAC Medical Center
    • Los Angeles, California, United States, 90033
      • University of Southern California - Norris Comprehensive Cancer Center
    • Orange, California, United States, 92868
      • UC - Irvine Chao Family Comprehensive Cancer Center
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Cancer Center
  • Georgia
    • Augusta, Georgia, United States, 30912
      • GRU Cancer Center - Georgia Regents University
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland - Greenebaum Cancer Center
    • Bethesda, Maryland, United States, 20892-1903
      • National Cancer Institute
  • Michigan
    • Grand Rapids, Michigan, United States, 49503
      • Cancer & Hematology Centers of Western Michigan
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
      • University of New Mexico
  • New York
    • Commack, New York, United States, 11725
      • The Long Islan Brain Tumor Center at Neurological Surgery P.C.
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599-7295
      • University of North Carolina at Chapel Hill
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15232
      • UPMC Cancer Center
    • Pittsburgh, Pennsylvania, United States, 15213
      • Magee Womens Hospital
  • Texas
    • Houston, Texas, United States, 77030
      • MD Anderson Cancer Center
    • San Antonio, Texas, United States, 78229
      • Univeristy of Texas Health Science Center in San Antonio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Drug: ANG1005

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of intracranial objective response		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)
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
Plasma pharmacokinetics of ANG1005	To determine the drug concentration and distribution in the plasma. (AUC, Cmax, T1/2)	On Day 1 of Cycles 1 and 3
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)

Collaborators and Investigators

• Sponsor: Angiochem Inc

Publications and helpful links

Helpful Links

• Safety, pharmacokinetics, and activity of GRN1005, a novel conjugate of angiopep-2, a peptide facilitating brain penetration, and paclitaxel, in patients with advanced solid tumors

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2014
• Primary Completion (ACTUAL): March 1, 2016
• Study Completion (ACTUAL): September 1, 2017

Study Registration Dates

• First Submitted: January 21, 2014
• First Submitted That Met QC Criteria: January 27, 2014
• First Posted (ESTIMATE): January 29, 2014

Study Record Updates

• Last Update Posted (ACTUAL): February 25, 2020
• Last Update Submitted That Met QC Criteria: February 19, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Breast cancer; Targeted therapy; Brain tumor; Triple Negative; Trastuzumab; Paclitaxel; Taxol; Herceptin; Triple negative breast cancer (TNBC); HER2-negative; Brain metastases; Blood-brain barrier; ANG1005; GRN1005; Low-density lipoprotein receptor-related protein (LRP-1); Breast cancer with brain metastases; Herceptin 2 (HER2)-positive; Metastatic brain tumors
• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Neoplastic Processes; Central Nervous System Neoplasms; Nervous System Neoplasms; Breast Neoplasms; Neoplasm Metastasis; Brain Neoplasms; Neoplasms, Second Primary
• Other Study ID Numbers: ANG1005-CLN-04