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

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Lung Cancer Drug: Imetelstat Sodium (GRN163L) Phase 1

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study of GRN163L in Combination With Paclitaxel and Carboplatin in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer
Study Start Date : July 2007
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
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.
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.

Primary Outcome Measures :
  1. Safety and MTD [ Time Frame: First 3 weeks ]

Secondary Outcome Measures :
  1. PK and efficacy [ Time Frame: Baseline to end of treatment ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00510445

United States, Maryland
University of Maryland Greenebaum Cancer Center
Baltimore, Maryland, United States, 21201
United States, Texas
The University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
United States, Wisconsin
University of Wisconsin, Paul P. Carbone Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
Geron Corporation

Additional Information:
Responsible Party: Geron Corporation Identifier: NCT00510445     History of Changes
Other Study ID Numbers: GRN163L CP14A005
First Posted: August 2, 2007    Key Record Dates
Last Update Posted: December 24, 2015
Last Verified: December 2015

Keywords provided by Geron Corporation:
Non Small Cell Lung Cancer
Advanced Non Small Cell Lung Cancer
Metastatic Non Small Cell Lung Cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action