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

Breast Neoplasm Clinical Trial

Official title:

A Randomized Phase II Study of AFP464 +/- Faslodex in ER Positive Breast Cancer Patients Who Had Progressed on Aromatase Inhibitor (AI) Therapy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01233947
• Other study ID #: TG-AFP-003
• Status: Terminated
• Phase: Phase 2
• First received: November 1, 2010
• Last updated: January 6, 2012
• Start date: May 2011
• Est. completion date: August 2012

Study information

• Verified date: January 2012
• Source: Tigris Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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,

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasm
• Breast Neoplasms

Intervention

Drug:
• AFP464
AFP464 administered as a 3-hour IV infusion on Days 1 and 8 of a 21-day cycle
• 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

Locations

Country	Name	City	State
United States	Texas Oncology-Baylor Charles A. Sammons Cancer Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Tigris Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Benefit Response	Clinical Benefit Response (CBR) defined as Complete Response, Partial Response or Stable Disease for 6 months.	6 months	No
Secondary	Progression Free Survival	Determination of progression free survival	6 months	No
Secondary	Number of participants with adverse events	Determination of the number of patients who experience adverse events	6 months	Yes