Phase 2 Study of ABT-869 in Combination With Paclitaxel Versus Paclitaxel Alone to Treat Metastatic Breast Cancer

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to determine the effect of ABT-869 plus paclitaxel compared to paclitaxel alone on disease progression in metastatic breast cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AbbVie (prior sponsor, Abbott)
• Collaborator: Genentech, Inc.
• Treatments: Albumin-Bound Paclitaxel; Paclitaxel

Criteria

Inclusion Criteria:

• Subject must be female and > 18 years of age.

• Subject must be diagnosed with adenocarcinoma of the breast.

• Subject must have metastatic disease or locally recurrent disease that is not amenable to surgical resection with curative intent.

• No prior chemotherapy for locally recurrent or metastatic breast cancer.

• At least 12 months since prior adjuvant or neoadjuvant chemotherapy (including prior taxane therapy and prior anti-angiogenic therapy [i.e. bevacizumab or a TKI]).

• No HER-2 -over-expression (3+) breast cancer (unless treated with trastuzumab or lapatinib).

• Subject has measurable disease by RECIST criteria (randomized portion only).

• Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-1.

• Subject must have adequate bone marrow, renal and hepatic function.

• Subject must have PTT < 1.5 x ULN and INR < 1.5.

Exclusion Criteria:

• Subject has received anti-cancer therapy (other than chemotherapy) including investigational agents, or biologic therapy within 21 days or within a period defined by 5 half lives, whichever is shorter, prior to Study Day 1.

• Subject has not recovered to less than or equal to grade 1 clinically significant adverse effects/toxicities of the previous therapy.

• Subject has received radiation therapy within 14 days of Study Day 1.

• Subject has received anti-cancer hormonal therapy within 14 days of Study Day 1.

• Subject has undergone major surgery within 21 days of Study Day 1.

• The subject has untreated brain or meningeal metastases.

• Subject is receiving therapeutic anticoagulation therapy.

• Subject has a history of or currently exhibits clinically significant cancer related events of bleeding (e.g., hemoptysis).

• Subject currently exhibits symptomatic or persistent, uncontrolled hypertension.

• Subject has a history of myocardial infarction, stroke, or transient ischemic attack (TIA) within 6 months of study day 1.

• Subject has a documented left ventricular (LV) ejection fraction < 50%

• Subject has known autoimmune disease with renal involvement.