Efficacy Study of Aminoflavone Prodrug to Treat Breast Cancer

November 1, 2010 updated by: Tigris Pharmaceuticals

A Two-Arm Open Label Phase II Study of AFP464 (Aminoflavone Prodrug) in Previously-treated ER-positive or Triple-negative Breast Cancer Patients

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Aminoflavone Prodrug
Aminoflavone to treat ER positive breast cancer patients
Drug: Aminoflavone Prodrug
Aminoflavone Prodrug administered D1, D8 of 21-day cycle
Other Names:
  • AFP464
EXPERIMENTAL: Aminoflavone Prodrug with pretreatment
Aminoflavone Prodrug to treat Triple Negative Breast Cancer
Drug: Aminoflavone Prodrug
Aminoflavone Prodrug administered D1, D8 of 21-day cycle
Other Names:
  • AFP464

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical Benefit Response
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Progression Free Survival
Time Frame: 6 monhts
6 monhts

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tigris Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (ANTICIPATED)

December 1, 2012

Study Registration Dates

First Submitted

November 16, 2009

First Submitted That Met QC Criteria

November 17, 2009

First Posted (ESTIMATE)

November 18, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

November 3, 2010

Last Update Submitted That Met QC Criteria

November 1, 2010

Last Verified

November 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TG-AFP-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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