Status:
COMPLETED
Phase 2 Study of ABT-869 in Combination With Paclitaxel Versus Paclitaxel Alone to Treat Metastatic Breast Cancer
Lead Sponsor:
AbbVie (prior sponsor, Abbott)
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Metastatic Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief 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.
Detailed Description
Only the open-label lead-in portion of the study was enrolled (n=10). The randomized portion was not initiated. N = approximately 102 (90 randomized in a 1:1 ratio in Phase 2, approximately 6-12 enrol...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00645177
Start Date
July 1 2008
End Date
December 1 2009
Last Update
January 29 2013
Active Locations (3)
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1
Site Reference ID/Investigator# 8352
San Francisco, California, United States, 94115
2
Site Reference ID/Investigator# 6920
Harvey, Illinois, United States, 60426
3
Site Reference ID/Investigator# 10181
Durango, DGO., Mexico, CP 34000