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CompletedPhase 1NCT00510445
Official study title

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

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedImetelstat Sodium (GRN163L)

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Dec 24, 2015 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?4 U.S. locations

Locations may change over time.

Who runs it?Geron Corporation

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
Geron Corporation
Interventions being studied
Drug: Imetelstat Sodium (GRN163L)
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Disease setting
Metastatic or stage IV→
Treatment approach
Chemotherapy→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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%
Reasons someone may not be able to joinExclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • University of Maryland Greenebaum Cancer CenterBaltimore, Maryland
  • The University of Texas Southwestern Medical CenterDallas, Texas
  • UT MD Anderson Cancer CenterHouston, Texas
  • University of Wisconsin, Paul P. Carbone Comprehensive Cancer CenterMadison, Wisconsin

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Dec 24, 2015. Always confirm current availability with the study team.

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