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Non-small Cell Lung CancerPhase 2NCT01137968

Imetelstat as Maintenance Therapy After Initial Induction Chemotherapy in Non-small Cell Lung Cancer (NSCLC)

A Phase 2 study testing imetelstat and Bevacizumab in people with Non-small Cell Lung Cancer, run by Geron Corporation at 33 sites in 3 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 is to evaluate the efficacy and safety of imetelstat (GRN163L) as maintenance therapy for patients with advanced stage NSCLC who have not progressed after 4 cycles of platinum based therapy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-small Cell Lung Cancer
What is being tested?
imetelstat and Bevacizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
116 participants
Where
33 sitesin 3 countries
Study dates
May 2010to Sep 2013
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

  • Signed informed consent.
  • Ability and willingness to comply with requirements of the study protocol.
  • Male or female, age 18 or over.
  • Histologically or cytologically confirmed diagnosis of NSCLC
  • Stage IV (using the 7th edition of AJCC, or wet IIIb / IV using the 6th edition), or recurrent locally advanced disease not amenable to radiation or surgery with curative intent and not amenable to concurrent chemoradiation.
  • Patients have completed four to six cycles of platinum-based chemotherapy doublet for first line, advanced NSCLC, with no evidence of disease progression according to RECIST version 1.1. Adjuvant chemotherapy greater than one year prior to progression is allowed.
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  • Patients are willing and able to continue treatment with bevacizumab, if they received it with their platinum based chemotherapy.
  • ECOG performance status 0-1
  • Adequate bone marrow reserve as measured by ANC ≥ 1500/mm3, hemoglobin
  • ≥ 9 g/dL, platelet count ≥ 75,000 μL. Must be measured ≥ 1 week after last transfusion of blood products and/or last dose of hematopoietic growth factor.
  • Prothrombin time (PT) or INR or aPTT ≤ 1.5 x ULN.
  • Serum creatinine < 1.5 mg/dL or creatinine clearance > 45 mL/min.
  • Urinalysis with < 2+ protein or urinary excretion of < 2 g of protein/day (for patients to receive bevacizumab).
  • AST (SGOT) and ALT (SGPT) < 2.5 x the ULN, (AST (SGOT) and ALT (SGPT) < 5 x the ULN if documented liver metastases).
  • Serum bilirubin < 2.0 mg/dL (patients with Gilbert's syndrome: serum bilirubin < 3 x ULN).
  • Alkaline phosphatase < 2.5 x ULN (patients with documented liver or bone metastases, alkaline phosphatase ≤ 5 x ULN).
  • No other obvious related major organ toxicities which would compromise the patient's ability to participate in a clinical trial of a novel agent.
  • Patients may have received prior radiation therapy for local or locally advanced disease providing that any clinically significant adverse effects associated with prior therapy have recovered to Grade 1 or less.
  • Women of childbearing potential must have a negative serum pregnancy test and agree to use effective birth control during and for 12 weeks after the last treatment with imetelstat.
  • Males must agree to use effective birth control for themselves or their partner during and for 12 weeks after the last treatment with imetelstat.

Who cannot join

  • Patients who meet any of the following criteria will be excluded from screening and study entry:
  • Patients who are not eligible for induction therapy with a platinum based chemotherapy doublet.
  • Patients who have received, or are scheduled to receive pemetrexed or erlotinib as maintenance therapy.
  • Patients receiving bevacizumab must not have a recent history of hemoptysis ≥ ½ teaspoon of red blood or history of ≥ 2 g/24 hr urine protein while receiving prior bevacizumab, or squamous cell histology.
  • Patients will be excluded from being randomized if any of the following criteria apply:
  • Last dose of induction chemotherapy < 21 days prior to randomization or > 42 days prior to randomization
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  • History of pulmonary hemorrhage (> 1 teaspoon) within the 4 weeks prior to randomization.
  • Anti-platelet therapy within 2 weeks prior to randomization, other than low dose aspirin prophylaxis therapy.
  • Therapeutic anticoagulation therapy except for low dose warfarin (e.g., 1 mg by mouth per day).
  • Radiation therapy within 3 weeks prior to randomization (palliative radiation therapy is allowed, provided that sites of bone marrow production, i.e. iliac crests are not in the radiation field)
  • Major surgery within 4 weeks prior to first study drug administration (central line placement is allowed)
  • Active central nervous system (CNS) metastatic disease. Patients with stable CNS disease following completion of radiation therapy and/or surgery are eligible.
  • Any other active malignancy
  • Active or chronically recurrent bleeding (e.g., active peptic ulcer disease)
  • Clinically significant infection
  • Active autoimmune disease requiring immunosuppressive therapy
  • Clinically significant cardiovascular disease or condition including:
  • Congestive heart failure (CHF) requiring therapy
  • Need for anti-arrhythmic therapy for a ventricular arrhythmia
  • Severe conduction disturbance
  • Angina pectoris requiring therapy
  • Medically uncontrolled hypertension per the Investigator's discretion
  • Myocardial infarction within 6 months prior to first study drug administration
  • New York Heart Association Class II, III, or IV cardiovascular disease
  • Any other severe, acute, or chronic medical or psychiatric condition, laboratory abnormality, or difficulty complying with protocol requirements that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient inappropriate for the study.

Trial locations and contacts

33 sites in 3 countries.

33 sites in 3 countries

United States26 sites

  • Pacific Cancer Medical Center, Inc.

    Anaheim, California, 92801

  • University of Colorado Denver School of Medicine

    Aurora, Colorado, 80045

  • Auerbach Hematology Oncology

    Baltimore, Maryland, 21237

  • Hematology Oncology Centers

    Billings, Montana, 59101

  • Achieve Clinical Research, Llc

    Birmingham, Alabama, 35216

  • Blumenthal Cancer Center

    Charlotte, North Carolina, 28204

  • South Carolina Oncology Associates

    Columbia, South Carolina, 29210

  • UT Southwestern Medical Center

    Dallas, Texas, 75390

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Florida Cancer Specialists

    Fort Myers, Florida, 33901

  • Cancer Care Associates of Fresno Medical Group Inc

    Fresno, California, 93720

  • The Jones Clinic

    Germantown, Tennessee, 38138

  • Ingalls Memorial Hospital

    Harvey, Illinois, 60426

  • Clearview Cancer Institute

    Huntsville, Alabama, 35805

  • Integrated Community Oncology Network

    Jacksonville, Florida, 32256

  • University of Wisconsin

    Madison, Wisconsin, 53792

  • Montgomery Cancer Center

    Mount Sterling, Kentucky, 40353

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

  • St. Joseph's Hospital

    Orange, California, 92868

  • Kaiser Northwest

    Portland, Oregon, 97227

  • Swedish Cancer Institute

    Seattle, Washington, 98104

  • Northwest Medical Specialties

    Tacoma, Washington, 98405

  • H. Moffitt Lee Cancer Center

    Tampa, Florida, 33612

  • Scott and White Memorial Hospital (Texas A & M)

    Temple, Texas, 76508

  • Kaiser Permanente Medical Center

    Vallejo, California, 94589

  • Cancer Center of Kansas

    Wichita, Kansas, 67214

Other trials in United States

Germany5 sites

  • Krankenhaus Nordwest

    Frankfurt, Frankfurt, 60488

  • Asklepios Klinik Gauting GmbH

    Gauting, Munich, 82131

  • Krankenhaus Grosshansdorf

    Grosshansdorf, Free and Hanseatic City of Hamburg, 22927

  • Universitaetsklinikum Mainz

    Mainz, Mainz, 55131

  • Klinikum rechts der Isar der TU München

    München, Munich

Other trials in Germany

Canada2 sites

  • Hôpital Charles Lemoyne

    Greenfield Park, Quebec, J4V 2H1

  • Hospital Notre-Dame

    Montreal, Quebec, H2L 4M1

Other trials in Canada

About this study

Official title: A Randomized Phase II Study of Imetelstat as Maintenance Therapy After Initial Induction Chemotherapy for Advance Non-small Cell Lung Cancer(NSCLC)

The purpose of this is to evaluate the efficacy and safety of imetelstat (GRN163L) as maintenance therapy for patients with advanced stage NSCLC who have not progressed after 4 cycles of platinum based therapy.

Participants will be randomized in a 2:1 ratio to imetelstat + standard of care versus standard of care alone. Participants who received bevacizumab with their induction chemotherapy will continue to receive bevacizumab on this study.

Being tested
imetelstat, Bevacizumab
Keywords
imetelstat, imetelstat sodium, GRN163L, telomerase inhibitor, telomerase inhibition, maintenance therapy, non-small cell lung cancer, relapsed non-small cell lung cancer, advanced non-small cell lung cancer, NSCLC, cancer stem cells, Bevacizumab, post induction chemotherapy
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

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

  • imetelstatDrug

    Also called GRN163L

    9.4 mg/kg over a 2 hour IV infusion on Day 1 and Day 8 of each 21 day cycle until disease progression.

  • BevacizumabDrug

    Also called Avastin

    Dosage and duration will be according to the FDA-approved bevacizumab package insert. Bevacizumab will be administered on Day 1 of each 21-day cycle.

Study groups in NCT01137968
Study groupRoleWhat they receive
imetelstat plus standard of careExperimentalimetelstat plus standard of care (bevacizumab or observation)
Receives: Drug: imetelstat; Drug: Bevacizumab
Standard of careOtherBevacizumab or observation
Receives: Drug: Bevacizumab

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 or death, whichever occurs earlier,as determined by the Investigator's assessment according to RECIST, or death from any cause, whichever occurs earlier.

    Measured: From randomization to documented disease progression or death, whichever occurs earlier, through the end of the study period (8 mos. after the last participant is randomized)

Secondary outcomes (3)

  1. Objective response

    Objective response (partial response plus complete response) occurring post-randomization as determined by the Investigator's assessment according to RECIST criteria using post-induction tumor dimensions as a baseline.

    Measured: Occurring post randomization through end of study period (8 mos. after the last participant is randomized)

  2. Time to all-cause mortality

    Defined as the time from the date of radomization to death from any cause during the study period.

    Measured: From the date of randomization through end of study period (8 mos. after the last participant is randomized)

  3. Safety and tolerability

    Safety and tolerability will be assessed by the incidence, nature, and severity of adverse events, laboratory abnormalities, and vital signs.

    Measured: From the date of randomization through the end of the study period (8 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 posted7 Jun 2010 (estimated)
  2. Study startMay 2010
  3. Primary completionSep 2013
  4. Study completionSep 2013

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
116 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01137968
Sponsor's protocol ID
CP14B012
Status last verified
Mar 2015
First submitted
3 Jun 2010
Last updated
26 Jan 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing imetelstat and Bevacizumab in people with Non-small Cell Lung Cancer, run by Geron Corporation at 33 sites in 3 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 20 inclusion and 25 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 33 sites in United States, Germany, 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: From randomization to documented disease progression or death, whichever occurs earlier, through the end of the study period (8 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 NCT01137968.

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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