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Study of GRN163L With Paclitaxel and Carboplatin in Patients With Advanced or Metastatic Non Small Cell Lung Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

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

NCT00510445•Geron Corporation

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

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
+5 more criteria

Locations (4)

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

Key Dates

Start Date

July 1, 2007

Primary Completion Date

April 1, 2011

Completion Date

April 1, 2011

Last Updated

December 24, 2015

Enrollment

ACTUAL participants

Conditions

Lung Cancer

Interventions

Imetelstat Sodium (GRN163L)

DRUG

A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)

NCT07190248

Non-small Cell Lung Cancer

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Locally Advanced Alveolar Soft Part SarcomaMetastatic Alveolar Soft Part Sarcoma+8 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 24, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)

A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing

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