Status:
WITHDRAWN
Phase 1 Study of Fusilev® to Prevent or Reduce Mucositis in Patients With Non-Small Cell Lung Cancer Receiving Folotyn®
Lead Sponsor:
Acrotech Biopharma Inc.
Conditions:
Non-Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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.
Detailed Description
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-re...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01820091
Start Date
April 1 2013
End Date
April 1 2015
Last Update
January 23 2020
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