Study of AFP464 +/- Faslodex in ER + Breast Cancer
This study has been terminated.
Sponsor:
Tigris Pharmaceuticals
Information provided by:
Tigris Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01233947
First received: November 1, 2010
Last updated: January 6, 2012
Last verified: January 2012
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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:
Genetics Home Reference related topics:
breast cancer
Drug Information available for:
Fulvestrant
U.S. FDA Resources
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
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 Antineoplastic Agents Therapeutic Uses |
Pharmacologic Actions Estrogen Antagonists Estrogen Receptor Modulators Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 22, 2013