Phase 1 Study of Fusilev® to Prevent or Reduce Mucositis in Patients With Non-Small Cell Lung Cancer Receiving Folotyn®
Status and phase
Withdrawn
Phase 1
Conditions
Non-Small Cell Lung Cancer
Treatments
Drug: Folotyn
Drug: Fusilev
Details and patient eligibility
About
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.
Full 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-related Grade 3 or higher oral mucositis.
Sex
All
Ages
18+ years old
Volunteers
No Healthy Volunteers
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
Trial design
Primary purpose
Prevention
Allocation
Non-Randomized
Interventional model
Parallel Assignment
Masking
None (Open label)
0 participants in 5 patient groups
Cohort 1 - Fusilev - 20 doses
Experimental group
Description:
5 mg/m2 QID (6 hours apart) starting on Days 2 and 16 (24 hours after Folotyn dose) for a total of 20 doses in a 28-day cycle
Days 2 and 16: 4 doses/day
Days 3 and 17: 4 doses/day
Days 4 and 18: 2 doses/day
Folotyn: 190 mg/m2 on Days 1 and 15 in a 28-day cycle
Treatment:
Drug: Fusilev
Drug: Folotyn
Cohort 2 - Fusilev - 12 doses
Experimental group
Description:
5 mg/m2 BID 8 hours apart on Days 2, 3, 4, 16, 17, and 18 for a total of 12 doses in a 28-day cycle.
Fusilev dose to start 24 hours after Folotyn dose.
Folotyn: 190 mg/m2 on Days 1 and 15 in a 28-day cycle
Treatment:
Drug: Fusilev
Drug: Folotyn
Cohort 3 - Fusilev - 8 doses
Experimental group
Description:
5 mg/m2 BID 8 hours apart on Days 2, 3, 16, and 17 for a total of 8 doses in a 28-day cycle.
Fusilev dose to start 24 hours after Folotyn dose.
Folotyn: 190 mg/m2 on Days 1 and 15 in a 28-day cycle
Treatment:
Drug: Fusilev
Drug: Folotyn
Cohort 4 - Fusilev - 4 doses
Experimental group
Description:
5 mg/m2 BID 8 hours apart on Days 2 and 16 for a total of 4 doses in a 28-day cycle.
Fusilev dose to start 24 hours after Folotyn dose.
Folotyn: 190 mg/m2 on Days 1 and 15 in a 28-day cycle
Treatment:
Drug: Fusilev
Drug: Folotyn
Cohort 5 - Fusilev - 2 doses
Experimental group
Description:
5 mg/m2 once on Days 2 and 16 for a total of 2 doses in a 28-day cycle
Folotyn: 190 mg/m2 on Days 1 and 15 in a 28-day cycle
Treatment:
Drug: Fusilev
Drug: Folotyn
Trial contacts and locations
0
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Data sourced from clinicaltrials.gov
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