We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

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.
ClinicalTrials.gov 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Recruitment Status : Withdrawn (Study was not initiated as planned)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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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 ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Binh Nguyen, MD PhD, Chief Medical Officer
ClinicalTrials.gov 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