Clareo Health | Study of Talabostat and Pemetrexed vs. Pemetrexed in Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC) After Failure of Platinum-Based Chemotherapy
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Point Therapeutics
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Men or women age ≥18 years
Histologically or cytologically confirmed NSCLC (Recurrent, locally advanced or metastatic, inoperable NSCLC \[Stage IIIB/IV\]. Patients with Stage IIIB NSCLC must have a cytologically documented pleural effusion.)
Failed or relapsed after receiving a platinum-containing chemotherapy regimen as first-line therapy for advanced NSCLC
Measurable disease on computerized tomography (CT) scan
ECOG Performance Status of 0 or 1
Expected survival ≥12 weeks
Provide written informed consent
You may not be if
More than 2 prior chemotherapy regimens
Progression of disease on prior pemetrexed treatment
Brain metastases (exception: patients who had a resection and/or completed a course of cranial irradiation, have no worsening CNS symptoms, and have discontinued all corticosteroids for that indication for at least 1 month)
Serum creatinine ≥2.0mg/dL or creatinine clearance \<45mL/min
Absolute neutrophil count \<1500/μL or platelets \<100,000/μL
Any malignancy within 5 years immediately prior to the first dose of study medication (exception: basal cell or non-metastatic squamous cell carcinoma of the skin, and carcinoma in-situ of the cervix)
Any comorbidity or condition which, in the opinion of the investigator, may interfere with the assessments and procedures of this protocol
Patients who are within 28 days of chemotherapy, radiation therapy, immunotherapy, or investigational medication for NSCLC. Patients must have recovered from all of the side effects of treatment.
Pregnancy or lactation. Women of childbearing potential and non-vasectomized men must agree to use a barrier method of contraception during treatment.
