NCT01015521

Brief Summary

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

Trial Health

10
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 16, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 18, 2009

Completed
4 months until next milestone

Study Start

First participant enrolled

April 1, 2010

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Last Updated

November 3, 2010

Status Verified

November 1, 2010

Enrollment Period

2.7 years

First QC Date

November 16, 2009

Last Update Submit

November 1, 2010

Conditions

Breast Neoplasm

Keywords

breast cancer

Outcome Measures

Primary Outcomes (1)

  • Clinical Benefit Response

    6 months

Secondary Outcomes (1)

  • Progression Free Survival

    6 monhts

Study Arms (2)

Aminoflavone Prodrug

EXPERIMENTAL

Aminoflavone to treat ER positive breast cancer patients

Drug: Aminoflavone Prodrug

Aminoflavone Prodrug with pretreatment

EXPERIMENTAL

Aminoflavone Prodrug to treat Triple Negative Breast Cancer

Drug: Aminoflavone Prodrug

Interventions

Aminoflavone ProdrugDRUG

Aminoflavone Prodrug administered D1, D8 of 21-day cycle

Also known as: AFP464
Aminoflavone ProdrugAminoflavone Prodrug with pretreatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • symptomatic pulmonary disease
  • brain metastases
  • pregnant females

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 27900579DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 16, 2009

First Posted

November 18, 2009

Study Start

April 1, 2010

Primary Completion

December 1, 2012

Last Updated

November 3, 2010

Record last verified: 2010-11