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OpenTrials
Completed

NCT Number: NCT02048059

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.

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Key information

Conditions

Breast Cancer Brain Diseases Brain Metastases Brain Neoplasms Breast Diseases Breast Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Skin Diseases Skin and Connective Tissue Diseases Triple Negative Breast Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Arizona Cancer Center, Tucson, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥ 18 years old
  • Breast cancer
  • Recurrent brain metastases from breast cancer
  • At least one radiologically-confirmed and measurable metastatic brain lesion ( ≥ 0.5 cm)
  • Neurologically stable
  • Karnofsky Performance Status (KPS) score ≥ 70
  • Adequate hematology and serum chemistry laboratory test results
  • Expected survival of ≥ 3 months

Exclusion criteria

  • Prior treatment with ANG1005/GRN1005
  • Evidence of symptomatic intracranial hemorrhage
  • Pregnancy or lactation
  • Inadequate bone marrow reserve
  • Any evidence of severe or uncontrolled diseases
  • Patients with the presence of an infection including abscess or fistulae, or known infection with hepatitis B or C or HIV
  • History of interstitial lung disease or evidence of clinically significant interstitial lung disease
  • Severe cardiac conduction disturbance
  • Central nervous system (CNS) disease requiring immediate neurosurgery intervention
  • Known severe hypersensitivity or allergy to paclitaxel or any of its components

Treatment and study plan

ANG1005

Drug

Primary outcomes

  1. Intracranial objective response rate (iORR)

    Time frame: Upon enrollment through end of study period (1 year after last patient is enrolled)

Secondary outcomes

  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)

Sponsors and collaborators

Lead sponsor

Angiochem Inc

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Jan 29, 2014
Registry last updated
Feb 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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