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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Locally Recurrent or Metastatic Breast Cancer

Thank you

Trial Information

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


Patients will be randomized in a 1:1 ratio to imetelstat + paclitaxel (with or without
bevacizumab) versus paclitaxel (with or without bevacizumab) alone.

Inclusion 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)

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Progression-free survival

Outcome Description:

Defined as the time from randomization to documented disease progression, as determined by the investigator's assessment according to RECIST, or death from any cause, whichever occurs first.

Outcome Time Frame:

Occurring post randomization through end of study period (9 mos. after the last participant is randomized)

Safety Issue:

No

Principal Investigator

Ted Shih, PharmD

Investigator Role:

Study Director

Investigator Affiliation:

Geron Corporation

Authority:

United States: Food and Drug Administration

Study ID:

CP14B014

NCT ID:

NCT01256762

Start Date:

November 2010

Completion Date:

December 2012

Related Keywords:

  • Locally Recurrent or Metastatic Breast Cancer
  • imetelstat
  • imetelstat sodium
  • GRN163L
  • telomerase inhibitor
  • telomerase inhibition
  • metastatic breast cancer
  • locally recurrent breast cancer
  • Bevacizumab
  • Paclitaxel
  • Avastin
  • Taxol
  • HER-2-negative
  • First-Line Chemotherapy
  • Second-Line Chemotherapy
  • Breast Neoplasms

Name

Location

Ingalls Memorial Hospital Harvey, Illinois  60426
Michigan State University East Lansing, Michigan  48824
Hematology Oncology Associates Atlantis, Florida  33462
Northeast Georgia Medical Center Gainesville, Georgia  30501
Florida Oncology Associates Orange Park, Florida  32073
Cancer Care Associates Tulsa, Oklahoma  74136
Northern Utah Associates Ogden, Utah  84403
Kootenai Medical Center Coeur d'Alene, Idaho  83814
H. Lee Moffitt Cancer Center Tampa, Florida  33612
Emory University Atlanta, Georgia  30322
Cancer Care Associates Fresno, California  93720
Redwood Regional Medical Group Santa Rosa, California  95403
The West Clinic Memphis, Tennessee  38120
Northwest Medical Specialties Tacoma, Washington  98405
Peninsula Cancer Institute Newport News, Virginia  23601
Indiana University Indianapolis, Indiana  46202
The Jones Clinic Germantown, Tennessee  38138
Cancer Center of Kansas Wichita, Kansas  67214
New Mexico Cancer Center Albuquerque, New Mexico  87109
Southbay Oncology Hematology Partners Campbell, California  95008
Horizon Oncology Center Lafayette, Indiana  47905
Northeast Georgia Cancer Care Athens, Georgia  30607
Summit Cancer Care Savannah, Georgia  31405
Rush University Chicago, Illinois  60612
Mercy Physicians of Oklahoma Tulsa, Oklahoma  74136
Clearview Cancer Center Huntsville, Alabama  35801
Central Georgia Cancer Care Macon, Georgia  31201
St. Joseph Hospital Orange, California  92868
Connecticut Oncology & Hematology Torrington, Connecticut  06790
Alta Bates Summit Medical Center Berkeley, California  94704
Kaiser Northwest Portland, Oregon  97227
Medical Oncology Associates Spokane, Washington  99208
UC San Diego La Jolla, California  92093
Memorial Miller Hospital Long Beach, California  90806
Desert Regional Comprehensive Cancer Center Palm Springs, California  92262
Univ. Colorado at Denver Aurora, Colorado  80045
Medical Oncology Hematology Waterbury, Connecticut  06708
Peachtree Hematology Oncology Atlanta, Georgia  30318
Mid Illinois Hematology & Oncology Normal, Illinois  61761
Cancer Treatment Centers of America Zion, Illinois  60099
Community Hospitals of Indiana Indianapolis, Indiana  46268
Montgomery Cancer Care Mount Sterling, Kentucky  40353
Prohealth Associates Lake Success, New York  11402
Stony Brook University Stony Brook, New York  11794
Carolinas Hematology/Oncology Charlotte, North Carolina  28203
Moses Cone Medical System Greensboro, North Carolina  27403
Case Western Reserve Univ. Cleveland, Ohio  44106
Pinnacle Health Harrisburg, Pennsylvania  17110
Penn. State Univ. Hershey, Pennsylvania  17033
Scott & White Healthcare Temple, Texas  76508