Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AFP464 | Experimental | 74 mg/m2 AFP464 administered as a 3 hour IV infusion on Days 1 and 8 of a 21-day cycle. |
|
| AFP464 + Faslodex | Experimental | AFP464 administered as a 3 hour IV infusion on Days 1 and 8 of a 21-day cycles and Faslodex administered per package label. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AFP464 | Drug | AFP464 administered as a 3-hour IV infusion on Days 1 and 8 of a 21-day cycle |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Benefit Response | Clinical Benefit Response (CBR) defined as Complete Response, Partial Response or Stable Disease for 6 months. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival | Determination of progression free survival | 6 months |
| Number of participants with adverse events | Determination of the number of patients who experience adverse events |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Joanne L. Blume, M.D. | Texas Oncology-Baylor Charles A. Sammons Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Texas Oncology-Baylor Charles A. Sammons Cancer Center | Dallas | Texas | 75246 | United States |
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C413760 | aminoflavone |
| D000077267 | Fulvestrant |
| ID | Term |
|---|---|
| D004958 | Estradiol |
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| AFP464 + Faslodex | Drug | 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 |
|
|
| 6 months |
| D017437 |
| Skin and Connective Tissue Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |