Status:
COMPLETED
Imetelstat in Combination With Paclitaxel (With or Without Bevacizumab) in Patients With Locally Recurrent or Metastatic Breast Cancer
Lead Sponsor:
Geron Corporation
Conditions:
Locally Recurrent or Metastatic Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of treatment with imetelstat + paclitaxel (with or without bevacizumab) versus paclitaxel (with or without bevacizumab) alone for patie...
Detailed Description
Patients will be randomized in a 1:1 ratio to imetelstat + paclitaxel (with or without bevacizumab) versus paclitaxel (with or without bevacizumab) alone.
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Histologically or cytologically confirmed adenocarcinoma of the breast that is either locally recurrent or metastatic. Locally recurrent disease must not be amenable to surgical resection or radiation with curative intent
- Either have not received chemotherapy or may have had one prior non-taxane chemotherapy regimen for metastatic disease (there are no restrictions on prior hormonal therapy)
- Prior use of bevacizumab is allowed provided that it was not administered in combination with a taxane
- ECOG performance status 0-1
- Adequate bone marrow reserve as indicated by:
- ANC \> 1500/uL (without use of growth factors within 7 days)
- Platelet count \> 100,000 (without transfusion in prior 7 days)
- Hemoglobin \> 9.0 g/dL
- Exclusion Criteria:
- Women who are pregnant or breast feeding
- Locally recurrent disease amenable to resection with curative intent
- HER-2-positive breast cancer
- Active central nervous system (CNS) metastatic disease including those patients receiving radiotherapy and/or steroid treatment (within the last 3 months)
- Prior adjuvant or neoadjuvant taxane chemotherapy within 12 months prior of first relapse
- Investigational therapy within 4 weeks of first study drug administration
- Prior radiation, cytotoxic, or hormonal therapy within 2 weeks of first study drug administration
- Therapeutic anti-coagulation or regular use of anti-platelet therapy within 2 weeks prior to first study drug administration (low dose anti-coagulant therapy to maintain patency of a vascular access device is allowed)
- Grade ≥ 2 neuropathy
- Uncontrolled clinically significant atrial or ventricular arrhythmias (unless pacemaker in place)
- Severe conduction disturbance including clinically significant QTC prolongation \> 450 ms (unless pacemaker in place)
- Active or chronically recurrent bleeding (e.g., active peptic ulcer disease)
- Clinically relevant active infection
- Known positive serology for human immunodeficiency virus (HIV)
Exclusion
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
166 Patients enrolled
Trial Details
Trial ID
NCT01256762
Start Date
November 1 2010
End Date
December 1 2012
Last Update
January 26 2016
Active Locations (55)
Enter a location and click search to find clinical trials sorted by distance.
1
Clearview Cancer Center
Huntsville, Alabama, United States, 35805
2
Alta Bates Summit Medical Center
Berkeley, California, United States, 94704
3
Southbay Oncology Hematology Partners
Campbell, California, United States, 95008
4
Cancer Care Associates
Fresno, California, United States, 93720