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

Phase 2
18 Years
Open (Enrolling)
Non-small Cell Lung Cancer

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Trial Information

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

Inclusion Criteria:

- 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.

- 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

- 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

- Males must agree to use effective birth control for themselves or their partner
during and for 12 weeks after the last treatment with imetelstat.

Exclusion Criteria:

Patients who meet any of the following criteria will be excluded from screening and study

- 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

- History of pulmonary hemorrhage (> 1 teaspoon) within the 4 weeks prior to

- 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.

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

Outcome 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)

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:

May 2010

Completion Date:

June 2013

Related Keywords:

  • Non-Small Cell Lung Cancer
  • 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
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Ingalls Memorial Hospital Harvey, Illinois  60426
Swedish Cancer Institute Seattle, Washington  98104
Florida Cancer Specialists Fort Myers, Florida  33901
Integrated Community Oncology Network Jacksonville Beach, Florida  32250
South Carolina Oncology Associates Columbia, South Carolina  29201
Kaiser Permanente Medical Center Vallejo, California  94589
Blumenthal Cancer Center Charlotte, North Carolina  28203
Northwest Medical Specialties Tacoma, Washington  98405
Karmanos Cancer Institute Detroit, Michigan  48201
The Jones Clinic Germantown, Tennessee  38138
University of Wisconsin Madison,, Wisconsin  53792-5666
Clearview Cancer Institute Huntsville, Alabama  35805
Ut Southwestern Medical Center Dallas, Texas  75390
Cancer Center of Kansas Wichita, Kansas  67214
Sarah Cannon Research Institute Nashville, Tennessee  37203
Montgomery Cancer Center Mt. Sterling, Kentucky  40353
Pacific Cancer Medical Center, Inc. Anaheim, California  92801
Achieve Clinical Research, LLC Tuscaloosa, Alabama  35406
Cancer Care Associates of Fresno Medical Group Inc Fresno, California  93720
St. Joseph's Hospital Orange, California  92868
University of Colorado Denver School of Medicine Aurora, Colorado  80045
H. Moffitt Lee Cancer Center Tampa, Florida  33612
Auerbach Hematology Oncology Baltimore, Maryland  21237
Hematology Oncology Centers Billings, Montana  59101
Kaiser Northwest Portland, Oregon  97227
Scott and White Memorial Hospital (Texas A & M) Temple, Texas  76508