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Imetelstat in Combination With Paclitaxel (With or Without Bevacizumab) in Patients With Locally Recurrent or Metastatic Breast Cancer

Information source: Geron Corporation
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Locally Recurrent or Metastatic Breast Cancer

Intervention: Imetelstat sodium (Drug); Bevacizumab (Drug); Paclitaxel (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Geron Corporation

Official(s) and/or principal investigator(s):
Ted Shih, PharmD, Study Director, Affiliation: Geron Corporation
Kathy Miller, MD, Principal Investigator, Affiliation: Indiana University Simon Cancer Center

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 patients with locally recurrent or metastatic breast cancer who have not received chemotherapy or have received one non-taxane based chemotherapy for metastatic breast cancer.

Clinical Details

Official title: A Randomized Phase II Study Of Imetelstat (GRN163L) In Combination With Paclitaxel (With Or Without Bevacizumab) in Patients With Locally Recurrent Or Metastatic Breast Cancer

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Progression-free survival

Secondary outcome:

Objective response

Clinical benefit rate

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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)

Locations and Contacts

Clearview Cancer Center, Huntsville, Alabama 35805, United States

Alta Bates Summit Medical Center, Berkeley, California 94704, United States

Southbay Oncology Hematology Partners, Campbell, California 95008, United States

Cancer Care Associates, Fresno, California 93720, United States

Memorial Miller Hospital, Long Beach, California 90806, United States

St. Joseph Hospital, Orange, California 92868, United States

Desert Regional Comprehensive Cancer Center, Palm Springs, California 92262, United States

UC San Diego, San Diego, California 92093, United States

Redwood Regional Medical Group, Santa Rosa, California 95403, United States

Univ. Colorado at Denver, Aurora, Colorado 80045, United States

Connecticut Oncology & Hematology, Torrington, Connecticut 06790, United States

Medical Oncology Hematology, Waterbury, Connecticut 06708, United States

Florida Oncology Associates, Jacksonville, Florida 32256, United States

Hematology Oncology Associates, Port St. Lucie, Florida 34952, United States

H. Lee Moffitt Cancer Center, Tampa, Florida 33612, United States

Northeast Georgia Cancer Care, Athens, Georgia 30607, United States

Emory University, Atlanta, Georgia 30322, United States

Peachtree Hematology Oncology, Atlanta, Georgia 30318, United States

Northeast Georgia Medical Center, Gainesville, Georgia 30501, United States

Central Georgia Cancer Care, Macon, Georgia 31201, United States

Summit Cancer Care, Savannah, Georgia 31405, United States

Kootenai Medical Center, Post Falls, Idaho 83854, United States

Ingalls Memorial Hospital, Chicago, Illinois 60426, United States

Rush University, Chicago, Illinois 60612, United States

Mid Illinois Hematology & Oncology, Normal, Illinois 61761, United States

Cancer Treatment Centers of America, Zion, Illinois 60099, United States

Community Hospitals of Indiana, Indianapolis, Indiana 46268, United States

Indiana University, Indianapolis, Indiana 46202, United States

Horizon Oncology Center, Lafayette, Indiana 47905, United States

Cancer Center of Kansas, Wichita, Kansas 67214, United States

Montgomery Cancer Care, Mount Sterling, Kentucky 40353, United States

Michigan State University, East Lansing, Michigan 48823, United States

New Mexico Cancer Center, Albuquerque, New Mexico 87109, United States

Prohealth Associates, Lake Success, New York 11402, United States

Stony Brook University, Stony Brook, New York 11794, United States

Carolinas Hematology/Oncology, Charlotte, North Carolina 28203, United States

Moses Cone Medical System, Greensboro, North Carolina 27403, United States

Case Western Reserve Univ., Cleveland, Ohio 44106, United States

Mercy Physicians of Oklahoma, Oklahoma City, Oklahoma 73120, United States

Cancer Care Associates, Tulsa, Oklahoma 74136, United States

Grand River Regional Cancer Centre, Kitchener, Ontario N2G 1G3, Canada

Stronach Regional Cancer Centre at Southlake, Newmarket, Ontario L3Y 2P9, Canada

The Ottawa Hospital Cancer Centre, Ottawa, Ontario K1H 8L6, Canada

Sunnybrook Health Services Centre, Toronto, Ontario M4N 3M5, Canada

Kaiser Northwest, Portland, Oregon 97232, United States

Pinnacle Health, Harrisburg, Pennsylvania 17110, United States

Penn. State Univ., Hershey, Pennsylvania 17033, United States

McGill University, Montreal, Quebec H2W 1S6, Canada

The Jones Clinic, Germantown, Tennessee 38138, United States

The West Clinic, Memphis, Tennessee 38120, United States

Scott & White Healthcare, Temple, Texas 76508, United States

Northern Utah Associates, Ogden, Utah 84403, United States

Peninsula Cancer Institute, Newport News, Virginia 23601, United States

Medical Oncology Associates, Spokane, Washington 99208, United States

Northwest Medical Specialties, Tacoma, Washington 98405, United States

Additional Information

Related publications:

Hochreiter AE, Xiao H, Goldblatt EM, Gryaznov SM, Miller KD, Badve S, Sledge GW, Herbert BS. Telomerase template antagonist GRN163L disrupts telomere maintenance, tumor growth, and metastasis of breast cancer. Clin Cancer Res. 2006 May 15;12(10):3184-92.

Goldblatt EM, Gentry ER, Fox MJ, Gryaznov SM, Shen C, Herbert BS. The telomerase template antagonist GRN163L alters MDA-MB-231 breast cancer cell morphology, inhibits growth, and augments the effects of paclitaxel. Mol Cancer Ther. 2009 Jul;8(7):2027-35. doi: 10.1158/1535-7163.MCT-08-1188. Epub 2009 Jun 9.

Herbert BS, Wright WE, Shay JW. Telomerase and breast cancer. Breast Cancer Res. 2001;3(3):146-9. Epub 2001 Feb 22. Review.

Starting date: November 2010
Last updated: March 13, 2015

Page last updated: August 23, 2015

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