Study of GRN163L With Paclitaxel and Carboplatin in Patients With Advanced or Metastatic Non Small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00510445
Recruitment Status : Completed
First Posted : August 2, 2007
Last Update Posted : December 24, 2015
Information provided by (Responsible Party):
Geron Corporation

July 31, 2007
August 2, 2007
December 24, 2015
July 2007
April 2011   (Final data collection date for primary outcome measure)
Safety and MTD [ Time Frame: First 3 weeks ]
  • Safety will be determined by PE, lab toxicity, and incidence and severity of AEs
  • Maximum tolerated dose will be determined by the observed occurrence of dose limiting toxicities.
  • Tolerability of each dose administration
Complete list of historical versions of study NCT00510445 on Archive Site
PK and efficacy [ Time Frame: Baseline to end of treatment ]
  • Pharmacokinetics will be determined by serial measurements of its concentration in plasma
  • Efficacy will be determined by evidence of OR, PFS, and OS calculated from the start of treatment.
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Study of GRN163L With Paclitaxel and Carboplatin in Patients With Advanced or Metastatic Non Small Cell Lung Cancer
A Phase I Study of GRN163L in Combination With Paclitaxel and Carboplatin in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer
The purpose of this study is to determine the safety and the maximum tolerated dose (MTD) of GRN163L when administered in combination with a standard paclitaxel/carboplatin regimen to patients with advanced or metastatic non-small cell lung cancer.
GRN163L is a telomerase template antagonist with in vitro and in vivo activity in a variety of tumor model systems. Telomerase is an enzyme that is active primarily in tumor cells and is crucial for the indefinite growth of tumor cells. Inhibition of telomerase may result in antineoplastic effects.
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Lung Cancer
Drug: Imetelstat Sodium (GRN163L)

The starting dose of GRN163L for this study will be 3.2 mg/kg. Subsequent dose levels will be 4.8, 6, 7.5, 9, 11, and 13.5 mg/kg. The maximum dose to be administered will not exceed 13.5 mg/kg.

Paclitaxel and carboplatin will be administered on Day 2 of each 21-day cycle.

Experimental: Single Arm Trial
Patients will be enrolled in the order of confirmation of eligibility. Dose cohorts will be filled sequentially with a minimum of 3 patients. Once assigned to a dose cohort, each patient will continue to be treated at the same dose level throughout the course of the study.
Intervention: Drug: Imetelstat Sodium (GRN163L)
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
April 2011
April 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histologically or cytologically confirmed diagnosis of NSCLC
  • Stage IIIb with pleural effusion, Stage IV, or recurrent disease
  • Measurable or evaluable disease by RECIST criteria
  • ECOG performance status 0-1
  • Adequate hepatic/renal function and platelet count
  • If previously treated with an anthracycline, anthracenedione, or trastuzumab, must have left ventricular ejection fraction > 50%

Exclusion Criteria:

  • More than 2 prior chemotherapy regimens for metastatic disease (prior adjuvant chemotherapy is allowed)
  • Tumor progression during treatment with paclitaxel (refractory to paclitaxel)
  • Taxane-based regimen within 12 weeks
  • Any systemic therapy for cancer within 4 weeks
  • Anti-platelet therapy within 2 weeks, other than low dose aspirin prophylaxis therapy
  • Therapeutic anticoagulation therapy except for low dose warfarin (eg, 1 mg by mouth per day)
  • Radiation therapy within 3 weeks
  • Major surgery within 4 weeks (central line placement is allowed)
  • Prolongation of PT or aPTT > the ULN or fibrinogen < the LLN
  • History of or active central nervous system metastatic disease
  • Any other active malignancy
  • Active or chronically recurrent bleeding (eg, active peptic ulcer disease)
  • Clinically significant infection
  • Active autoimmune disease requiring immunosuppressive therapy
  • Clinically significant cardiovascular disease or condition
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
GRN163L CP14A005
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Geron Corporation
Geron Corporation
Not Provided
Not Provided
Geron Corporation
December 2015

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