Study of GRN163L With Paclitaxel and Carboplatin in Patients With Advanced or Metastatic Non Small Cell Lung Cancer
NCT ID: NCT00510445
Last Updated: 2015-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
27 participants
INTERVENTIONAL
2007-07-31
2011-04-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Geron Corporation
INDUSTRY
Responsible Party
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Locations
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University of Maryland Greenebaum Cancer Center
Baltimore, Maryland, United States
The University of Texas Southwestern Medical Center
Dallas, Texas, United States
UT MD Anderson Cancer Center
Houston, Texas, United States
University of Wisconsin, Paul P. Carbone Comprehensive Cancer Center
Madison, Wisconsin, United States
Countries
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Related Links
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Related Info
Other Identifiers
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GRN163L CP14A005
Identifier Type: -
Identifier Source: org_study_id