Clinical trial NCT02048059: ANG1005 in Breast Cancer Patients With Recurrent Brain Metastases
Official title: A Phase II, Open-Label, Multi-Center Study of ANG1005 in Breast Cancer Patients With Recurrent Brain Metastases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Brain Metastases
Keywords: ANG1005
GRN1005
Low-density lipoprotein receptor-related protein (LRP-1)
Targeted therapy
Breast cancer
Brain metastases
Brain tumor
Blood-brain barrier
Trastuzumab
Herceptin
Paclitaxel
Taxol
Breast cancer with brain metastases
Triple Negative
Triple negative breast cancer (TNBC)
Herceptin 2 (HER2)-positive
HER2-negative
Metastatic brain tumors
Lead sponsor: Angiochem Inc
Sponsor class: INDUSTRY
First posted: 2014-01-29
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Intracranial objective response rate (iORR)
timeFrame: Upon enrollment through end of study period (1 year after last patient is enrolled)
Secondary outcomes:
measure: Duration of intracranial objective response
timeFrame: Upon enrollment through end of study period (1 year after last patient is enrolled)
measure: Median intracranial progression-free survival (PFS)
timeFrame: Upon enrollment through end of study period (1 year after last patient is enrolled)
measure: Intracranial PFS rates at 3, 6 and 12 months
timeFrame: Upon enrollment through end of study period (1 year after last patient is enrolled)
measure: 6-month overall survival (OS) rate
timeFrame: Upon enrollment through end of study period (1 year after last patient is enrolled
measure: Extracranial objective response rate (eORR) and duration of response
timeFrame: Upon enrollment through end of study period (1 year after last patient is enrolled
measure: Number of Patients with adverse events
timeFrame: Upon enrollment through end of study period (1 year after last patient is enrolled
measure: Plasma pharmacokinetics of ANG1005
timeFrame: On Day 1 of Cycles 1 and 3
measure: Intracranial ORR by modified Response Assessment in Neuro-Oncology (RANO) criteria
timeFrame: Upon enrollment through end of study period (1 year after last patient is enrolled)
measure: Intracranial clinical benefit rate (iCBR) at 3 and 6 months
timeFrame: Upon enrollment through end of study period (1 year after last patient is enrolled)
measure: Potential immunogenicity of ANG1005
timeFrame: Upon enrollment through end of study period (1 year after last patient is enrolled)
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona Cancer Center
state: Arizona
city: La Jolla
country: United States
facility: UC San Diego Moores Cancer Center
state: California
city: Los Angeles
country: United States
facility: University of California - LAC Medical Center
state: California
city: Los Angeles
country: United States
facility: University of Southern California - Norris Comprehensive Cancer Center
state: California
city: Orange
country: United States
facility: UC - Irvine Chao Family Comprehensive Cancer Center
state: California
city: Aurora
country: United States
facility: University of Colorado Cancer Center
state: Colorado
city: Augusta
country: United States
facility: GRU Cancer Center - Georgia Regents University
state: Georgia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Baltimore
country: United States
facility: University of Maryland - Greenebaum Cancer Center
state: Maryland
city: Bethesda
country: United States
facility: National Cancer Institute
state: Maryland
city: Grand Rapids
country: United States
facility: Cancer & Hematology Centers of Western Michigan
state: Michigan
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
city: Commack
country: United States
facility: The Long Islan Brain Tumor Center at Neurological Surgery P.C.
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Pittsburgh
country: United States
facility: Magee Womens Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Cancer Center
state: Pennsylvania
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: San Antonio
country: United States
facility: Univeristy of Texas Health Science Center in San Antonio
state: Texas
Study officials:
affiliation: Angiochem Inc
name: Betty Lawrence
role: STUDY_DIRECTOR
References: