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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 HospitalHarvey, Illinois  60426
Michigan State UniversityEast Lansing, Michigan  48824
Hematology Oncology AssociatesAtlantis, Florida  33462
Northeast Georgia Medical CenterGainesville, Georgia  30501
Florida Oncology AssociatesOrange Park, Florida  32073
Cancer Care AssociatesTulsa, Oklahoma  74136
Northern Utah AssociatesOgden, Utah  84403
Kootenai Medical CenterCoeur d'Alene, Idaho  83814
H. Lee Moffitt Cancer CenterTampa, Florida  33612
Emory UniversityAtlanta, Georgia  30322
Cancer Care AssociatesFresno, California  93720
Redwood Regional Medical GroupSanta Rosa, California  95403
The West ClinicMemphis, Tennessee  38120
Northwest Medical SpecialtiesTacoma, Washington  98405
Peninsula Cancer InstituteNewport News, Virginia  23601
Indiana UniversityIndianapolis, Indiana  46202
The Jones ClinicGermantown, Tennessee  38138
Cancer Center of KansasWichita, Kansas  67214
New Mexico Cancer CenterAlbuquerque, New Mexico  87109
Southbay Oncology Hematology PartnersCampbell, California  95008
Horizon Oncology CenterLafayette, Indiana  47905
Northeast Georgia Cancer CareAthens, Georgia  30607
Summit Cancer CareSavannah, Georgia  31405
Rush UniversityChicago, Illinois  60612
Mercy Physicians of OklahomaTulsa, Oklahoma  74136
Clearview Cancer CenterHuntsville, Alabama  35801
Central Georgia Cancer CareMacon, Georgia  31201
St. Joseph HospitalOrange, California  92868
Connecticut Oncology & HematologyTorrington, Connecticut  06790
Alta Bates Summit Medical CenterBerkeley, California  94704
Kaiser NorthwestPortland, Oregon  97227
Medical Oncology AssociatesSpokane, Washington  99208
UC San DiegoLa Jolla, California  92093
Memorial Miller HospitalLong Beach, California  90806
Desert Regional Comprehensive Cancer CenterPalm Springs, California  92262
Univ. Colorado at DenverAurora, Colorado  80045
Medical Oncology HematologyWaterbury, Connecticut  06708
Peachtree Hematology OncologyAtlanta, Georgia  30318
Mid Illinois Hematology & OncologyNormal, Illinois  61761
Cancer Treatment Centers of AmericaZion, Illinois  60099
Community Hospitals of IndianaIndianapolis, Indiana  46268
Montgomery Cancer CareMount Sterling, Kentucky  40353
Prohealth AssociatesLake Success, New York  11402
Stony Brook UniversityStony Brook, New York  11794
Carolinas Hematology/OncologyCharlotte, North Carolina  28203
Moses Cone Medical SystemGreensboro, North Carolina  27403
Case Western Reserve Univ.Cleveland, Ohio  44106
Pinnacle HealthHarrisburg, Pennsylvania  17110
Penn. State Univ.Hershey, Pennsylvania  17033
Scott & White HealthcareTemple, Texas  76508