Study of AFP464 +/- Faslodex in ER + Breast Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01233947|
Recruitment Status : Terminated
First Posted : November 3, 2010
Last Update Posted : January 9, 2012
|Condition or disease||Intervention/treatment||Phase|
|Breast Neoplasm||Drug: AFP464 Drug: AFP464 + Faslodex||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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 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)
- Clinical Benefit Response [ Time Frame: 6 months ]Clinical Benefit Response (CBR) defined as Complete Response, Partial Response or Stable Disease for 6 months.
- Progression Free Survival [ Time Frame: 6 months ]Determination of progression free survival
- Number of participants with adverse events [ Time Frame: 6 months ]Determination of the number of patients who experience adverse events
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
|United States, Texas|
|Texas Oncology-Baylor Charles A. Sammons Cancer Center|
|Dallas, Texas, United States, 75246|
|Principal Investigator:||Joanne L. Blume, M.D.||Texas Oncology-Baylor Charles A. Sammons Cancer Center|