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

Tigris Pharmaceuticals

Status and phase: Terminated; Phase 2

Conditions: Breast Neoplasm

Treatments: Drug: AFP464; Drug: AFP464 + Faslodex

Study type: Interventional

Funder types: Industry

Identifiers

NCT01233947

TG-AFP-003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 7 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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,

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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7 participants in 2 patient groups

AFP464

Experimental group

Description:

74 mg/m2 AFP464 administered as a 3 hour IV infusion on Days 1 and 8 of a 21-day cycle.

Treatment:

Drug: AFP464

AFP464 + Faslodex

Experimental group

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.

Treatment:

Drug: AFP464 + Faslodex