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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Geron Corporation

ClinicalTrials.gov Identifier:

NCT00510445

First received: July 31, 2007

Last updated: January 24, 2012

Last verified: January 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	July 31, 2007
Last Updated Date	January 24, 2012
Start Date ^ICMJE	July 2007
Primary Completion Date	April 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: July 16, 2008)	Safety and MTD [ Time Frame: First 3 weeks ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE (submitted: July 31, 2007)	Tolerability of each dose administration 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.
Change History	Complete list of historical versions of study NCT00510445 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: July 16, 2008)	PK and efficacy [ Time Frame: Baseline to end of treatment ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE (submitted: July 31, 2007)	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.
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Study of GRN163L With Paclitaxel and Carboplatin in Patients With Advanced or Metastatic Non Small Cell Lung Cancer
Official Title ^ICMJE	A Phase I Study of GRN163L in Combination With Paclitaxel and Carboplatin in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer
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.
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Lung Cancer
Intervention ^ICMJE	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.
Study Arm (s)	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)
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	27
Completion Date	April 2011
Primary Completion Date	April 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00510445
Other Study ID Numbers ^ICMJE	GRN163L CP14A005
Has Data Monitoring Committee	No
Responsible Party	Geron Corporation
Study Sponsor ^ICMJE	Geron Corporation
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Geron Corporation
Verification Date	January 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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