A Study of GRN163L With Paclitaxel and Bevacizumab to Treat Patients With Locally Recurrent Or Metastatic Breast Cancer

Completed · Phase 1

Conditions studied: Breast Cancer

In brief

The purpose of this study is to determine the maximum tolerated dose (MTD) of GRN163L in combination with paclitaxel and bevacizumab in patients with locally recurrent or metastatic breast cancer (MBC)

Key facts

Study ID

NCT00732056

Run by

Geron Corporation

People needed

24

Starts

2008-07-01

Expected to finish

2012-03-01

Last updated by the study team

2015-12-24

Who can join

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

You may qualify if…

• Histologically or cytologically confirmed adenocarcinoma of the breast with measurable locally recurrent or metastatic disease
• May have had one prior non-taxane chemotherapy regimen for metastatic disease
• If HER2 positive, must have had prior treatment with trastuzumab (Herceptin®)
• If previously treated with an anthracycline, anthracenedione, or trastuzumab must be tested by MUGA scan or echocardiogram and have LVEF ≥ 50%
• Must have recovered from most recent radiation treatment or surgical procedure
• ECOG performance status of 0 or 1
• Life expectancy ≥ 3 months

You may not qualify if…

• Locally recurrent disease amenable to resection with curative intent
• Prior adjuvant or neoadjuvant taxane chemotherapy within 12 months prior to first study drug administration
• Investigational therapy within 4 weeks prior to first study drug administration
• Prior hormonal therapy within 2 weeks prior to first study drug administration
• Prior radiotherapy within 2 weeks prior to first study drug administration
• Cytotoxic chemotherapy within 2 weeks prior to first study drug administration
• Therapeutic anticoagulation or regular use of anti-platelet therapy within 2 weeks prior to first study drug administration NOTE: Low-dose anticoagulant therapy to maintain patency of a vascular access device is allowed.
• Prolongation of PT or INR, aPTT > ULN, or fibrinogen < LLN
• Active or chronically current bleeding (eg, active peptic ulcer)
• Clinically significant cardiovascular or cerebrovascular disease including
• Any history of:
• Cerebrovascular disease including TIA, stroke or subarachnoid hemorrhage
• Ischemic bowel
• Within the last 12 months:
• MI
• Unstable angina
• NYHA grade II or greater CHF
• Grade 2 or greater peripheral vascular disease
• Active at study entry:
• Uncontrolled hypertension defined as SBP > 160 or DBP > 90
• Uncontrolled or clinically significant arrhythmia
• Clinically relevant active infection
• Nonhealing wound or fracture
• Serious co-morbid medical conditions, including cirrhosis and chronic obstructive or chronic restrictive pulmonary disease
• Active autoimmune disease requiring immunosuppressive therapy

Where it is running

• Ingalls Memorial Hospital — Harvey, Illinois, United States
• Indiana University Melvin and Bren Simon Cancer Center — Indianapolis, Indiana, United States

Full record on ClinicalTrials.gov

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