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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Geron Corporation
ClinicalTrials.gov Identifier:
NCT01256762
First received: December 2, 2010
Last updated: January 27, 2013
Last verified: January 2013

December 2, 2010
January 27, 2013
November 2010
October 2012   (final data collection date for primary outcome measure)
Progression-free survival [ Time Frame: Occurring post randomization through end of study period (9 mos. after the last participant is randomized) ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01256762 on ClinicalTrials.gov Archive Site
  • Objective response [ Time Frame: Occurring post randomization through end of study period (9 mos. after the last participant is randomized) ] [ Designated as safety issue: No ]
    Objective response as determined by the investigator according to RECIST for patients with measurable disease at baseline.
  • Clinical benefit rate [ Time Frame: Occurring post randomization through end of study period (9 mos. after the last participant is randomized) ] [ Designated as safety issue: No ]
    Clinical response rate includes patients with objective response and stable disease lasting at least 6 months.
  • Objective response [ Time Frame: Occurring post randomization through end of study period (9 mos. after the last participant is randomized) ] [ Designated as safety issue: No ]
    Objective response as determined by the investigator according to RECIST for patients with measurable disease at baseline.
  • Clinical benefit rate [ Time Frame: Occurring post randomization through end of study period (9 mos. after the last participant is randomized) ] [ Designated as safety issue: No ]
    Clinical response rate includes patients with objective response and stable disease lasting at least 6 months.
  • The safety and tolerability [ Time Frame: Occurring post randomization through end of study period (9 mos. after the last participant is randomized) ] [ Designated as safety issue: Yes ]
    Safety and tolerability will be assessed by the incidence, nature, and severity of adverse events, laboratory abnormalities, and vital signs.
Not Provided
Not Provided
 
Imetelstat in Combination With Paclitaxel (With or Without Bevacizumab) in Patients With Locally Recurrent or Metastatic Breast Cancer
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

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.

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

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Locally Recurrent or Metastatic Breast Cancer
  • Drug: Imetelstat sodium
    Imetelstat is administered at a dose of 300 mg/m2 on day one of a 21 day cycle.
    Other Name: GRN163L
  • Drug: Bevacizumab
    Bevacizumab is administered at 15 mg/kg on day one of a 21 day cycle
    Other Name: Avastin
  • Drug: Paclitaxel
    Paclitaxel is administered at 90 mg/m2 on days one and eight of a 21 day cycle
    Other Name: Taxol
  • Experimental: Imetelstat + Paclitaxel (with or without bevacizumab)
    Interventions:
    • Drug: Imetelstat sodium
    • Drug: Bevacizumab
    • Drug: Paclitaxel
  • Experimental: Paclitaxel (with or without bevacizumab) alone
    Interventions:
    • Drug: Bevacizumab
    • Drug: Paclitaxel

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
166
December 2012
October 2012   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT01256762
CP14B014
No
Geron Corporation
Geron Corporation
Not Provided
Study Director: Ted Shih, PharmD Geron Corporation
Principal Investigator: Kathy Miller, MD Indiana University Simon Cancer Center
Geron Corporation
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP