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This study has been withdrawn prior to enrollment.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
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, see Learn About Clinical Studies.

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 July 22, 2014