Phase 1 Study of Fusilev® to Prevent or Reduce Mucositis in Patients With Non-Small Cell Lung Cancer Receiving Folotyn®

• Status: Withdrawn
• Trial end date: 2015-04-01
• Target enrollment: 0
• Participant gender: All

Summary

To determine the optimal dose and schedule of Fusilev to prevent or reduce Folotyn-related Grade 3 or higher oral mucositis in patients with Non-Small Cell Lung Cancer.

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

Details

• Lead Sponsor: Acrotech Biopharma LLC; Spectrum Pharmaceuticals, Inc
• Treatments: Aminopterin; Leucovorin; Levoleucovorin

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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