Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Acrotech Biopharma Inc.
This is an open-label, uncontrolled, nonrandomized, multicenter, dose-finding, single-arm, Phase 1 study primarily to determine the optimal dose and schedule of Fusilev to prevent or reduce Folotyn-related Grade 3 or higher oral mucositis.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
At least 18 years of age
Relapsed or Refractory Non Small Cell Lung Cancer (NSCLC) after at least one line of therapy
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
Histologically or cytologically confirmed Stage III B/IV NSCLC
Adequate hematological, hepatic, and renal function
Available during the first 8 weeks of the study treatment period to visit the clinic for oral Mucositis assessments on scheduled days
You may not be if
Active concurrent malignancy. If there is a history of prior malignancies other than those exceptions listed above, the patient must be disease-free for at least 5 years
Congestive heart failure
Uncontrolled hypertension
Known human immunodeficiency virus (HIV)-positive diagnosis
Previous exposure to Pralatrexate
Pregnant or breast-feeding women
Major surgery within 14 days of enrollment
Active uncontrolled infection, underlying medical condition, or other serious illness that would impair the ability of the patient to receive protocol treatment
Symptomatic central nervous system (CNS) metastases or lesions for which treatment is required. Patients who received prophylactic CNS treatment are eligible
