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

Completed · Phase 1

Conditions studied: Lung Cancer

In brief

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.

Key facts

Study ID

NCT00510445

Run by

Geron Corporation

People needed

27

Starts

2007-07-01

Expected to finish

2011-04-01

Last updated by the study team

2015-12-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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%

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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