Don't get left behind! The modernized ClinicalTrials.gov is coming. Check it out now.
Say goodbye to ClinicalTrials.gov!
The new site is coming soon - go to the modernized ClinicalTrials.gov
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

ANG1005 in Breast Cancer Patients With Recurrent Brain Metastases

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02048059
Recruitment Status : Completed
First Posted : January 29, 2014
Last Update Posted : February 25, 2020
Sponsor:
Information provided by (Responsible Party):
Angiochem Inc

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Brain Metastases Drug: ANG1005 Phase 2

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II, Open-Label, Multi-Center Study of ANG1005 in Breast Cancer Patients With Recurrent Brain Metastases
Actual Study Start Date : April 2014
Actual Primary Completion Date : March 2016
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Intracranial objective response rate (iORR) [ Time Frame: Upon enrollment through end of study period (1 year after last patient is enrolled) ]

Secondary Outcome Measures :
  1. Duration of intracranial objective response [ Time Frame: Upon enrollment through end of study period (1 year after last patient is enrolled) ]
  2. Median intracranial progression-free survival (PFS) [ Time Frame: Upon enrollment through end of study period (1 year after last patient is enrolled) ]
  3. 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) ]
  4. 6-month overall survival (OS) rate [ Time Frame: Upon enrollment through end of study period (1 year after last patient is enrolled ]
  5. 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 ]
  6. Number of Patients with adverse events [ Time Frame: Upon enrollment through end of study period (1 year after last patient is enrolled ]
  7. Plasma pharmacokinetics of ANG1005 [ Time Frame: On Day 1 of Cycles 1 and 3 ]
    To determine the drug concentration and distribution in the plasma. (AUC, Cmax, T1/2)

  8. 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) ]
  9. Intracranial clinical benefit rate (iCBR) at 3 and 6 months [ Time Frame: Upon enrollment through end of study period (1 year after last patient is enrolled) ]
  10. Potential immunogenicity of ANG1005 [ Time Frame: Upon enrollment through end of study period (1 year after last patient is enrolled) ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02048059


Locations
Show Show 19 study locations
Sponsors and Collaborators
Angiochem Inc
Investigators
Layout table for investigator information
Study Director: Betty Lawrence Angiochem Inc
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
Responsible Party: Angiochem Inc
ClinicalTrials.gov Identifier: NCT02048059    
Other Study ID Numbers: ANG1005-CLN-04
First Posted: January 29, 2014    Key Record Dates
Last Update Posted: February 25, 2020
Last Verified: February 2020
Keywords provided by Angiochem Inc:
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Brain Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
 Neoplastic Processes
Pathologic Processes
Central Nervous System Neoplasms
Nervous System Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases