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

• Status: Completed
• Trial end date: 2011-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Geron Corporation
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Imetelstat; Motesanib diphosphate; Niacinamide; Paclitaxel

Criteria

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