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

Sponsor

Geron Corporation (Industry)

Overall Status

Completed

CT.gov ID

NCT00510445

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

6.8

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

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.

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 Design

Study Type:

Interventional

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 :

Jul 1, 2007

Actual Primary Completion Date :

Apr 1, 2011

Actual Study Completion Date :

Apr 1, 2011

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Safety and MTD [First 3 weeks]

Secondary Outcome Measures

PK and efficacy [Baseline to end of treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Maryland Greenebaum Cancer Center	Baltimore	Maryland	United States	21201
2	The University of Texas Southwestern Medical Center	Dallas	Texas	United States	75390
3	UT MD Anderson Cancer Center	Houston	Texas	United States	77030
4	University of Wisconsin, Paul P. Carbone Comprehensive Cancer Center	Madison	Wisconsin	United States	53792