Phase 1 Study of Fusilev® to Prevent or Reduce Mucositis in Patients With Non-Small Cell Lung Cancer Receiving Folotyn®
An Open Label, Multicenter, Dose Finding, Single Arm, Phase 1 Study of Fusilev® (Levoleucovorin) to Prevent or Reduce Mucositis in Patients With Relapsed or Refractory Non-Small Cell Lung Cancer Receiving Folotyn® (Pralatrexate)
1 other identifier
interventional
N/A
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Apr 2013
Shorter than P25 for phase_1 nonsmall-cell-lung-cancer
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 21, 2013
CompletedFirst Posted
Study publicly available on registry
March 28, 2013
CompletedStudy Start
First participant enrolled
April 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedJanuary 23, 2020
January 1, 2020
2 years
March 21, 2013
January 21, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Optimal dose and Schedule of Fusilev to prevent or reduce Oral Mucositis
The study period will begin on the first day of Folotyn treatment (Day 1). Folotyn will be administered intravenously (IV) at a dose of 190 mg/m2 on Days 1 and 15 in a 28-day treatment cycle. Twenty-four hours after the Folotyn dose, Fusilev will be administered either four times a day (QID) (6 hours apart, ±10 minutes), twice a day (BID) (8 hours apart, ±10 minutes) or once a day (QD) by IV push (3-5 minutes) at a dose of 5 mg/m2 according to the cohort to which patients are assigned. Within a given cohort, Fusilev will be administered at the same dose and schedule after each Folotyn dose for the duration of the study.
Up to 8 weeks
Secondary Outcomes (4)
Impact of Fusilev on the number of Folotyn-related dose modifications secondary to oral mucositis
Up to 8 weeks
Impact of Fusilev on the frequency of Oral Mucositis
Up to 8 weeks
Impact of Fusilev on use of Analgesics for Oral Mucositis
Up to 8 weeks
Impact of Fusilev on number of Folotyn doses delivered
Up to 8 weeks
Study Arms (5)
Cohort 1 - Fusilev - 20 doses
EXPERIMENTAL5 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
Cohort 2 - Fusilev - 12 doses
EXPERIMENTAL5 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
Cohort 3 - Fusilev - 8 doses
EXPERIMENTAL5 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
Cohort 4 - Fusilev - 4 doses
EXPERIMENTAL5 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
Cohort 5 - Fusilev - 2 doses
EXPERIMENTAL5 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
Interventions
A cycle of Folotyn treatment is 28 days, with treatment on Days 1 and 15 in each cycle.
Fusilev will be administered either four times a day (QID) (6 hours apart, ±10 minutes), twice a day (BID) (8 hours apart, ±10 minutes) or once a day (QD) by IV push (3-5 minutes) at a dose of 5 mg/m2 according to the cohort to which patients are assigned.
Eligibility Criteria
You may qualify 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 qualify 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 21, 2013
First Posted
March 28, 2013
Study Start
April 1, 2013
Primary Completion
April 1, 2015
Study Completion
April 1, 2015
Last Updated
January 23, 2020
Record last verified: 2020-01