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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase I Study of GRN163L in Combination With Paclitaxel and Carboplatin in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer

Conditions
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Lung Cancer

Intervention / Treatment
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* Drug: Imetelstat Sodium (GRN163L)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Arm Trial<br>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)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and MTD |  | First 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK and efficacy |  | Baseline to end of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non Small Cell Lung Cancer, Advanced Non Small Cell Lung Cancer, Metastatic Non Small Cell Lung Cancer