Back to resultsStudy of AFP464 +/- Faslodex in ER + Breast Cancer
Primary Purpose
Breast Neoplasm
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
AFP464
AFP464 + Faslodex
Sponsored by
About this trial
This is an interventional treatment trial for Breast Neoplasm
Eligibility 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,
Sites / Locations
- Texas Oncology-Baylor Charles A. Sammons Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
AFP464
AFP464 + Faslodex
Arm Description
74 mg/m2 AFP464 administered as a 3 hour IV infusion on Days 1 and 8 of a 21-day cycle.
AFP464 administered as a 3 hour IV infusion on Days 1 and 8 of a 21-day cycles and Faslodex administered per package label.
Outcomes
Primary Outcome Measures
Clinical Benefit Response
Clinical Benefit Response (CBR) defined as Complete Response, Partial Response or Stable Disease for 6 months.
Secondary Outcome Measures
Progression Free Survival
Determination of progression free survival
Number of participants with adverse events
Determination of the number of patients who experience adverse events
Full Information
NCT ID
NCT01233947
First Posted
November 1, 2010
Last Updated
January 6, 2012
Sponsor
Tigris Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT01233947
Brief Title
Study of AFP464 +/- Faslodex in ER + Breast Cancer
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 Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Terminated
Study Start Date
May 2011 (undefined)
Primary Completion Date
August 2012 (Anticipated)
Study Completion Date
August 2012 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Tigris Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasm
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AFP464
Arm Type
Experimental
Arm Description
74 mg/m2 AFP464 administered as a 3 hour IV infusion on Days 1 and 8 of a 21-day cycle.
Arm Title
AFP464 + Faslodex
Arm Type
Experimental
Arm Description
AFP464 administered as a 3 hour IV infusion on Days 1 and 8 of a 21-day cycles and Faslodex administered per package label.
Intervention Type
Drug
Intervention Name(s)
AFP464
Other Intervention Name(s)
(aminoflavone)
Intervention Description
AFP464 administered as a 3-hour IV infusion on Days 1 and 8 of a 21-day cycle
Intervention Type
Drug
Intervention Name(s)
AFP464 + Faslodex
Other Intervention Name(s)
(aminoflavone) + (Fulvestrant)
Intervention Description
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
Primary Outcome Measure Information:
Title
Clinical Benefit Response
Description
Clinical Benefit Response (CBR) defined as Complete Response, Partial Response or Stable Disease for 6 months.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Progression Free Survival
Description
Determination of progression free survival
Time Frame
6 months
Title
Number of participants with adverse events
Description
Determination of the number of patients who experience adverse events
Time Frame
6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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,
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joanne L. Blume, M.D.
Organizational Affiliation
Texas Oncology-Baylor Charles A. Sammons Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Texas Oncology-Baylor Charles A. Sammons Cancer Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
12. IPD Sharing Statement
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Study of AFP464 +/- Faslodex in ER + Breast Cancer
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