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

This study has been terminated.
Sponsor:
Information provided by:
Tigris Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01233947
First received: November 1, 2010
Last updated: January 6, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention Phase
Breast Neoplasm
Drug: AFP464
Drug: AFP464 + Faslodex
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Phase II Study of AFP464 +/- Faslodex in ER Positive Breast Cancer Patients Who Had Progressed on Aromatase Inhibitor (AI) Therapy

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 ]
    Clinical Benefit Response (CBR) defined as Complete Response, Partial Response or Stable Disease for 6 months.


Secondary Outcome Measures:
  • Progression Free Survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Determination of progression free survival

  • Number of participants with adverse events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Determination of the number of patients who experience adverse events


Enrollment: 7
Study Start Date: May 2011
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: (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 Name: (aminoflavone) + (Fulvestrant)

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.

  Eligibility

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

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,
  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.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01233947

Locations
United States, Texas
Texas Oncology-Baylor Charles A. Sammons Cancer Center
Dallas, Texas, United States, 75246
Sponsors and Collaborators
Tigris Pharmaceuticals
Investigators
Principal Investigator: Joanne L. Blume, M.D. Texas Oncology-Baylor Charles A. Sammons Cancer Center
  More Information

No publications provided

Responsible Party: Binh Nguyen, MD PhD / Chief Medical Officer, Tigris Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01233947     History of Changes
Other Study ID Numbers: TG-AFP-003
Study First Received: November 1, 2010
Last Updated: January 6, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Fulvestrant
Aromatase Inhibitors
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014