Efficacy Study of Aminoflavone Prodrug to Treat Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01015521
Recruitment Status : Withdrawn (Study was not initiated as planned)
First Posted : November 18, 2009
Last Update Posted : November 3, 2010
Information provided by:
Tigris Pharmaceuticals

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

Condition or disease Intervention/treatment Phase
Breast Neoplasm Drug: Aminoflavone Prodrug Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : April 2010
Estimated Primary Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

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 Name: 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 Name: AFP464

Primary Outcome Measures :
  1. Clinical Benefit Response [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Progression Free Survival [ Time Frame: 6 monhts ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Binh Nguyen, MD PhD, Chief Medical Officer Identifier: NCT01015521     History of Changes
Other Study ID Numbers: TG-AFP-002
First Posted: November 18, 2009    Key Record Dates
Last Update Posted: November 3, 2010
Last Verified: November 2010

Keywords provided by Tigris Pharmaceuticals:
breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases