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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
Not Enrolling
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

- Investigational therapy within 4 weeks of first study drug administration

- Prior radiation, cytotoxic, or hormonal therapy within 2 weeks of first study drug

- 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:


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:


Principal Investigator

Ted Shih, PharmD

Investigator Role:

Study Director

Investigator Affiliation:

Geron Corporation


United States: Food and Drug Administration

Study ID:




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



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