Efficacy Study of Aminoflavone Prodrug to Treat Breast Cancer

This study has been withdrawn prior to enrollment.
(Study was not initiated as planned)
Sponsor:
Information provided by:
Tigris Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01015521
First received: November 16, 2009
Last updated: November 1, 2010
Last verified: November 2010
  Purpose

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


Condition Intervention Phase
Breast Neoplasm
Drug: Aminoflavone Prodrug
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Tigris Pharmaceuticals:

Primary Outcome Measures:
  • Clinical Benefit Response [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression Free Survival [ Time Frame: 6 monhts ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: April 2010
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Binh Nguyen, MD PhD, Chief Medical Officer
ClinicalTrials.gov Identifier: NCT01015521     History of Changes
Other Study ID Numbers: TG-AFP-002
Study First Received: November 16, 2009
Last Updated: November 1, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Tigris Pharmaceuticals:
breast cancer

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

ClinicalTrials.gov processed this record on April 17, 2014