Study of GRN163L With Paclitaxel and Carboplatin in Patients With Advanced or Metastatic Non Small Cell Lung Cancer
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.
Checked against the public recordLast updated Dec 24, 2015 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Geron Corporation
- Interventions being studied
- Drug: Imetelstat Sodium (GRN163L)
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
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.