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

Primary Purpose

Lung Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Imetelstat Sodium (GRN163L)
Sponsored by
Geron Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring Non Small Cell Lung Cancer, Advanced Non Small Cell Lung Cancer, Metastatic Non Small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Maryland Greenebaum Cancer Center
  • The University of Texas Southwestern Medical Center
  • UT MD Anderson Cancer Center
  • University of Wisconsin, Paul P. Carbone Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single Arm Trial

Arm Description

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.

Outcomes

Primary Outcome Measures

Safety and MTD

Secondary Outcome Measures

PK and efficacy

Full Information

First Posted
July 31, 2007
Last Updated
December 22, 2015
Sponsor
Geron Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00510445
Brief Title
Study of GRN163L With Paclitaxel and Carboplatin in Patients With Advanced or Metastatic Non Small Cell Lung Cancer
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 Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Geron Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
Non Small Cell Lung Cancer, Advanced Non Small Cell Lung Cancer, Metastatic Non Small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single Arm Trial
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
Imetelstat Sodium (GRN163L)
Intervention Description
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 Measure Information:
Title
Safety and MTD
Time Frame
First 3 weeks
Secondary Outcome Measure Information:
Title
PK and efficacy
Time Frame
Baseline to end of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of Maryland Greenebaum Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
The University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
UT MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Wisconsin, Paul P. Carbone Comprehensive Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.geron.com
Description
Related Info

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

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