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Efficacy Study of Aminoflavone Prodrug to Treat Breast Cancer

Primary Purpose

Breast Neoplasm

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Aminoflavone Prodrug
Sponsored by
Tigris Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Neoplasm focused on measuring breast cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ER+ or TN Breast Cancer
  • Progression on an aromatase inhibitor if ER+
  • Prior treatment with taxane if TN
  • 18 years or older
  • Adequate organ function
  • Measurable lesion

Exclusion Criteria:

  • symptomatic pulmonary disease
  • brain metastases
  • pregnant females

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Aminoflavone Prodrug

    Aminoflavone Prodrug with pretreatment

    Arm Description

    Aminoflavone to treat ER positive breast cancer patients

    Aminoflavone Prodrug to treat Triple Negative Breast Cancer

    Outcomes

    Primary Outcome Measures

    Clinical Benefit Response

    Secondary Outcome Measures

    Progression Free Survival

    Full Information

    First Posted
    November 16, 2009
    Last Updated
    November 1, 2010
    Sponsor
    Tigris Pharmaceuticals
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01015521
    Brief Title
    Efficacy Study of Aminoflavone Prodrug to Treat Breast Cancer
    Official Title
    A Two-Arm Open Label Phase II Study of AFP464 (Aminoflavone Prodrug) in Previously-treated ER-positive or Triple-negative Breast Cancer Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2010
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Study was not initiated as planned
    Study Start Date
    April 2010 (undefined)
    Primary Completion Date
    December 2012 (Anticipated)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Tigris Pharmaceuticals

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This is a phase II study to assess the efficacy of Aminoflavone prodrug in triple negative and ER+ breast cancer.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Breast Neoplasm
    Keywords
    breast cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Aminoflavone Prodrug
    Arm Type
    Experimental
    Arm Description
    Aminoflavone to treat ER positive breast cancer patients
    Arm Title
    Aminoflavone Prodrug with pretreatment
    Arm Type
    Experimental
    Arm Description
    Aminoflavone Prodrug to treat Triple Negative Breast Cancer
    Intervention Type
    Drug
    Intervention Name(s)
    Aminoflavone Prodrug
    Other Intervention Name(s)
    AFP464
    Intervention Description
    Aminoflavone Prodrug administered D1, D8 of 21-day cycle
    Primary Outcome Measure Information:
    Title
    Clinical Benefit Response
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Progression Free Survival
    Time Frame
    6 monhts

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: ER+ or TN Breast Cancer Progression on an aromatase inhibitor if ER+ Prior treatment with taxane if TN 18 years or older Adequate organ function Measurable lesion Exclusion Criteria: symptomatic pulmonary disease brain metastases pregnant females

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    27900579
    Citation
    Saito R, Miki Y, Hata S, Ishida T, Suzuki T, Ohuchi N, Sasano H. Aryl hydrocarbon receptor induced intratumoral aromatase in breast cancer. Breast Cancer Res Treat. 2017 Feb;161(3):399-407. doi: 10.1007/s10549-016-4063-x. Epub 2016 Nov 30.
    Results Reference
    derived

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    Efficacy Study of Aminoflavone Prodrug to Treat Breast Cancer

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