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

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ClinicalTrials.gov Identifier: NCT01233947
Recruitment Status : Terminated
First Posted : November 3, 2010
Last Update Posted : January 9, 2012
Sponsor:
Information provided by:
Tigris Pharmaceuticals

Brief Summary:
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 or disease Intervention/treatment Phase
Breast Neoplasm Drug: AFP464 Drug: AFP464 + Faslodex Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : May 2011
Estimated Primary Completion Date : August 2012
Estimated Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Fulvestrant
U.S. FDA Resources

Arm Intervention/treatment
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)



Primary Outcome Measures :
  1. Clinical Benefit Response [ Time Frame: 6 months ]
    Clinical Benefit Response (CBR) defined as Complete Response, Partial Response or Stable Disease for 6 months.


Secondary Outcome Measures :
  1. Progression Free Survival [ Time Frame: 6 months ]
    Determination of progression free survival

  2. Number of participants with adverse events [ Time Frame: 6 months ]
    Determination of the number of patients who experience adverse events



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:   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,

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: November 3, 2010    Key Record Dates
Last Update Posted: January 9, 2012
Last Verified: January 2012

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Fulvestrant
Estradiol
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Estrogen Receptor Antagonists
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Estrogens
Hormones