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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Locally Recurrent or Metastatic Breast Cancer
 Drug: Imetelstat sodium
Drug: Bevacizumab
Drug: Paclitaxel
 Phase 2

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Geron Corporation:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 166
Study Start Date: November 2010
Study Completion Date: December 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Imetelstat + Paclitaxel (with or without bevacizumab) 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: Paclitaxel (with or without bevacizumab) alone 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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01256762

  Show 55 Study Locations
Sponsors and Collaborators
Geron Corporation
Investigators
Study Director: Ted Shih, PharmD Geron Corporation
Principal Investigator: Kathy Miller, MD Indiana University Simon Cancer Center
  More Information

Publications:

Responsible Party: Geron Corporation
ClinicalTrials.gov Identifier: NCT01256762     History of Changes
Other Study ID Numbers: CP14B014
Study First Received: December 2, 2010
Last Updated: January 27, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Geron Corporation:
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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Bevacizumab
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on May 23, 2013