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ANG1005 in Breast Cancer Patients With Recurrent Brain Metastases

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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

Tracking Information
First Submitted Date  ICMJE January 21, 2014
First Posted Date  ICMJE January 29, 2014
Last Update Posted Date February 25, 2020
Actual Study Start Date  ICMJE April 2014
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 20, 2017)
Intracranial objective response rate (iORR) [ Time Frame: Upon enrollment through end of study period (1 year after last patient is enrolled) ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 27, 2014)
Intracranial objective response rate [ Time Frame: Upon enrollment through end of study period (1 year after last patient is enrolled) ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 19, 2020)
  • 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 [ Time Frame: On Day 1 of Cycles 1 and 3 ]
    To determine the drug concentration and distribution in the plasma. (AUC, Cmax, T1/2)
  • 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) ]
  • 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) ]
  • Potential immunogenicity of ANG1005 [ Time Frame: Upon enrollment through end of study period (1 year after last patient is enrolled) ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 27, 2014)
  • 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 rate [ Time Frame: Upon enrollment through end of study period (1 year after last patient is enrolled ]
  • Extracranial ORR [ 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 ]
  • Pharmacokinetics [ Time Frame: On Day 1 of Cycles 1 and 3 ]
    To determine the drug concentration and distribution in the plasma. (AUC, Cmax, T1/2)
  • Duration of Response [ Time Frame: Upon enrollment through end of study period (1 year after last patient is enrolled) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ANG1005 in Breast Cancer Patients With Recurrent Brain Metastases
Official Title  ICMJE A Phase II, Open-Label, Multi-Center Study of ANG1005 in Breast Cancer Patients With Recurrent Brain Metastases
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Breast Cancer
  • Brain Metastases
Intervention  ICMJE Drug: ANG1005
Study Arms  ICMJE 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.
Intervention: Drug: ANG1005
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 20, 2017)
72
Original Estimated Enrollment  ICMJE
 (submitted: January 27, 2014)
40
Actual Study Completion Date  ICMJE September 2017
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02048059
Other Study ID Numbers  ICMJE ANG1005-CLN-04
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Angiochem Inc
Study Sponsor  ICMJE Angiochem Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Betty Lawrence Angiochem Inc
PRS Account Angiochem Inc
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP