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

Completed · Phase 2 · Has a placebo group

Conditions studied: Metastatic Breast Cancer

In brief

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.

Key facts

Study ID

NCT00645177

Run by

AbbVie (prior sponsor, Abbott)

People needed

10

Starts

2008-07-01

Expected to finish

2009-12-01

Last updated by the study team

2013-01-29

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Site Reference ID/Investigator# 8352 — San Francisco, California, United States
• Site Reference ID/Investigator# 6920 — Harvey, Illinois, United States
• Site Reference ID/Investigator# 10181 — Durango, DGO., Mexico

Full record on ClinicalTrials.gov

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