Study of AFP464 +/- Faslodex in ER + Breast Cancer

January 6, 2012 updated by: Tigris Pharmaceuticals

A Randomized Phase II Study of AFP464 +/- Faslodex in ER Positive Breast Cancer Patients Who Had Progressed on Aromatase Inhibitor (AI) Therapy

AFP464 is an investigational agent which may be effective in the treatment of cancer. The purpose of this study is to test the efficacy of AFP464 +/- Faslodex in ER+ breast cancer patients.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

This is a randomized, open-label study. Patients will be randomized in a 1:1 ratio to single arm AFP464, or AFP464+Faslodex. Patients will be treated until disease progression is noted.

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75246
        • Texas Oncology-Baylor Charles A. Sammons Cancer Center

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

Female

Description

Inclusion Criteria:

  • proven breast cancer, ER+ status; progression on an aromatase inhibitor; measurable disease or evaluable disease with serum CA27.29>=50 U/mL; adequate bone marrow, liver and renal function; DLco grade 0 or 1.

Exclusion Criteria:

  • HER2 positive, thoracic radiotherapy or symptomatic pulmonary disease, brain metastases,

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AFP464
74 mg/m2 AFP464 administered as a 3 hour IV infusion on Days 1 and 8 of a 21-day cycle.
Drug: AFP464
AFP464 administered as a 3-hour IV infusion on Days 1 and 8 of a 21-day cycle
Other Names:
  • (aminoflavone)
Experimental: AFP464 + Faslodex
AFP464 administered as a 3 hour IV infusion on Days 1 and 8 of a 21-day cycles and Faslodex administered per package label.
Drug: AFP464 + Faslodex
AFP464 administered as a 3-hour IV infusion on Days 1 and 8 of a 21-day cycles and faslodex administered per the package label
Other Names:
  • (aminoflavone) + (Fulvestrant)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Benefit Response
Time Frame: 6 months
Clinical Benefit Response (CBR) defined as Complete Response, Partial Response or Stable Disease for 6 months.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival
Time Frame: 6 months
Determination of progression free survival
6 months
Number of participants with adverse events
Time Frame: 6 months
Determination of the number of patients who experience adverse events
6 months

Collaborators and Investigators

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

Sponsor

Tigris Pharmaceuticals

Investigators

  • Principal Investigator: Joanne L. Blume, M.D., Texas Oncology-Baylor Charles A. Sammons Cancer Center

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

May 1, 2011

Primary Completion (Anticipated)

August 1, 2012

Study Completion (Anticipated)

August 1, 2012

Study Registration Dates

First Submitted

November 1, 2010

First Submitted That Met QC Criteria

November 2, 2010

First Posted (Estimate)

November 3, 2010

Study Record Updates

Last Update Posted (Estimate)

January 9, 2012

Last Update Submitted That Met QC Criteria

January 6, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TG-AFP-003

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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