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Locally Recurrent or Metastatic Breast CancerPhase 2NCT01256762

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

A Phase 2 study testing Imetelstat sodium, Bevacizumab and Paclitaxel in people with Locally Recurrent or Metastatic Breast Cancer, run by Geron Corporation at 55 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Imetelstat sodium, Bevacizumab and Paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
166 participants
Where
55 sitesin 2 countries
Study dates
Nov 2010to Dec 2012
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 14Show fewer
  • 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)

Trial locations and contacts

55 sites in 2 countries.

55 sites in 2 countries

United States50 sites

  • New Mexico Cancer Center

    Albuquerque, New Mexico, 87109

  • Northeast Georgia Cancer Care

    Athens, Georgia, 30607

  • Peachtree Hematology Oncology

    Atlanta, Georgia, 30318

  • Emory University

    Atlanta, Georgia, 30322

  • Univ. Colorado at Denver

    Aurora, Colorado, 80045

  • Alta Bates Summit Medical Center

    Berkeley, California, 94704

  • Southbay Oncology Hematology Partners

    Campbell, California, 95008

  • Carolinas Hematology/Oncology

    Charlotte, North Carolina, 28203

  • Ingalls Memorial Hospital

    Chicago, Illinois, 60426

  • Rush University

    Chicago, Illinois, 60612

  • Case Western Reserve Univ.

    Cleveland, Ohio, 44106

  • Michigan State University

    East Lansing, Michigan, 48823

  • Cancer Care Associates

    Fresno, California, 93720

  • Northeast Georgia Medical Center

    Gainesville, Georgia, 30501

  • The Jones Clinic

    Germantown, Tennessee, 38138

  • Moses Cone Medical System

    Greensboro, North Carolina, 27403

  • Pinnacle Health

    Harrisburg, Pennsylvania, 17110

  • Penn. State Univ.

    Hershey, Pennsylvania, 17033

  • Clearview Cancer Center

    Huntsville, Alabama, 35805

  • Indiana University

    Indianapolis, Indiana, 46202

  • Community Hospitals of Indiana

    Indianapolis, Indiana, 46268

  • Florida Oncology Associates

    Jacksonville, Florida, 32256

  • Horizon Oncology Center

    Lafayette, Indiana, 47905

  • Prohealth Associates

    Lake Success, New York, 11402

  • Memorial Miller Hospital

    Long Beach, California, 90806

  • Central Georgia Cancer Care

    Macon, Georgia, 31201

  • The West Clinic

    Memphis, Tennessee, 38120

  • Montgomery Cancer Care

    Mount Sterling, Kentucky, 40353

  • Peninsula Cancer Institute

    Newport News, Virginia, 23601

  • Mid Illinois Hematology & Oncology

    Normal, Illinois, 61761

  • Northern Utah Associates

    Ogden, Utah, 84403

  • Mercy Physicians of Oklahoma

    Oklahoma City, Oklahoma, 73120

  • St. Joseph Hospital

    Orange, California, 92868

  • Desert Regional Comprehensive Cancer Center

    Palm Springs, California, 92262

  • Hematology Oncology Associates

    Port Saint Lucie, Florida, 34952

  • Kaiser Northwest

    Portland, Oregon, 97232

  • Kootenai Medical Center

    Post Falls, Idaho, 83854

  • UC San Diego

    San Diego, California, 92093

  • Redwood Regional Medical Group

    Santa Rosa, California, 95403

  • Summit Cancer Care

    Savannah, Georgia, 31405

  • Medical Oncology Associates

    Spokane, Washington, 99208

  • Stony Brook University

    Stony Brook, New York, 11794

  • Northwest Medical Specialties

    Tacoma, Washington, 98405

  • H. Lee Moffitt Cancer Center

    Tampa, Florida, 33612

  • Scott & White Healthcare

    Temple, Texas, 76508

  • Connecticut Oncology & Hematology

    Torrington, Connecticut, 06790

  • Cancer Care Associates

    Tulsa, Oklahoma, 74136

  • Medical Oncology Hematology

    Waterbury, Connecticut, 06708

  • Cancer Center of Kansas

    Wichita, Kansas, 67214

  • Cancer Treatment Centers of America

    Zion, Illinois, 60099

Other trials in United States

Canada5 sites

  • Grand River Regional Cancer Centre

    Kitchener, Ontario, N2G 1G3

  • McGill University

    Montreal, Quebec, H2W 1S6

  • Stronach Regional Cancer Centre at Southlake

    Newmarket, Ontario, L3Y 2P9

  • The Ottawa Hospital Cancer Centre

    Ottawa, Ontario, K1H 8L6

  • Sunnybrook Health Services Centre

    Toronto, Ontario, M4N 3M5

Other trials in Canada

About this study

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

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.

Read the 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.

Being tested
Imetelstat sodium, Bevacizumab, Paclitaxel
Keywords
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
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Imetelstat sodiumDrug

    Also called GRN163L

    Imetelstat is administered at a dose of 300 mg/m2 on day one of a 21 day cycle.

  • BevacizumabDrug

    Also called Avastin

    Bevacizumab is administered at 15 mg/kg on day one of a 21 day cycle

  • PaclitaxelDrug

    Also called Taxol

    Paclitaxel is administered at 90 mg/m2 on days one and eight of a 21 day cycle

Study groups in NCT01256762
Study groupRoleWhat they receive
Imetelstat + Paclitaxel (with or without bevacizumab)ExperimentalNot described
Receives: Drug: Imetelstat sodium; Drug: Bevacizumab; Drug: Paclitaxel
Paclitaxel (with or without bevacizumab) aloneExperimentalNot described
Receives: Drug: Bevacizumab; Drug: Paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival

    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.

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

Secondary outcomes (2)

  1. Objective response

    Objective response as determined by the investigator according to RECIST for patients with measurable disease at baseline.

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

  2. Clinical benefit rate

    Clinical response rate includes patients with objective response and stable disease lasting at least 6 months.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2010 (estimated)
  2. Study startNov 2010
  3. Primary completionOct 2012
  4. Study completionDec 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
166 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01256762
Sponsor's protocol ID
CP14B014
Status last verified
Dec 2015
First submitted
2 Dec 2010
Last updated
26 Jan 2016
Results posted
No
Data monitoring committee
No

Publications

  • Hochreiter AE, Xiao H, Goldblatt EM, Gryaznov SM, Miller KD, Badve S, Sledge GW, Herbert BS. Telomerase template antagonist GRN163L disrupts telomere maintenance, tumor growth, and metastasis of breast cancer. Clin Cancer Res. 2006 May 15;12(10):3184-92. doi: 10.1158/1078-0432.CCR-05-2760.

    PubMed 16707619

  • Goldblatt EM, Gentry ER, Fox MJ, Gryaznov SM, Shen C, Herbert BS. The telomerase template antagonist GRN163L alters MDA-MB-231 breast cancer cell morphology, inhibits growth, and augments the effects of paclitaxel. Mol Cancer Ther. 2009 Jul;8(7):2027-35. doi: 10.1158/1535-7163.MCT-08-1188. Epub 2009 Jun 9.

    PubMed 19509275

  • Herbert BS, Wright WE, Shay JW. Telomerase and breast cancer. Breast Cancer Res. 2001;3(3):146-9. doi: 10.1186/bcr288. Epub 2001 Feb 22.

    PubMed 11305948

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Imetelstat sodium, Bevacizumab and Paclitaxel in people with Locally Recurrent or Metastatic Breast Cancer, run by Geron Corporation at 55 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 55 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (time frame: Occurring post randomization through end of study period (9 mos. after the last participant is randomized)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01256762, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2016.

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