- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01820091
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)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Phase
- Phase 1
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cohort 1 - Fusilev - 20 doses
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 |
A cycle of Folotyn treatment is 28 days, with treatment on Days 1 and 15 in each cycle.
Other Names:
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.
Other Names:
|
Experimental: Cohort 2 - Fusilev - 12 doses
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 |
A cycle of Folotyn treatment is 28 days, with treatment on Days 1 and 15 in each cycle.
Other Names:
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.
Other Names:
|
Experimental: Cohort 3 - Fusilev - 8 doses
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 |
A cycle of Folotyn treatment is 28 days, with treatment on Days 1 and 15 in each cycle.
Other Names:
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.
Other Names:
|
Experimental: Cohort 4 - Fusilev - 4 doses
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 |
A cycle of Folotyn treatment is 28 days, with treatment on Days 1 and 15 in each cycle.
Other Names:
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.
Other Names:
|
Experimental: Cohort 5 - Fusilev - 2 doses
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 |
A cycle of Folotyn treatment is 28 days, with treatment on Days 1 and 15 in each cycle.
Other Names:
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Optimal dose and Schedule of Fusilev to prevent or reduce Oral Mucositis
Time Frame: Up to 8 weeks
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Impact of Fusilev on the number of Folotyn-related dose modifications secondary to oral mucositis
Time Frame: Up to 8 weeks
|
Analysis will involve the number, percent and type of Folotyn dose modification as a function of Fusilev dose.
|
Up to 8 weeks
|
Impact of Fusilev on the frequency of Oral Mucositis
Time Frame: Up to 8 weeks
|
Distribution of the number of cases of oral mucositis will be described by cohort and by degree of mucositis.
|
Up to 8 weeks
|
Impact of Fusilev on use of Analgesics for Oral Mucositis
Time Frame: Up to 8 weeks
|
Oral mucositis assessment form will be provided by the sponsor and is to be completed during treatment visits on day 1 & 15, days 4 &18, end of treatment visits.
Patients will complete an Oral Mucositis Daily Questionnaire (OMDQ) starting at Day 1 of Cycle 1 and ending at the End of Treatment visit.
Oral mucositis assessment will be assessed in the clinic by the investigator, or designee, and graded according to AE severity as established in the NCI CTCAE scale, Version 4.0.
|
Up to 8 weeks
|
Impact of Fusilev on number of Folotyn doses delivered
Time Frame: Up to 8 weeks
|
All treatment-emergent AEs will be managed per the investigator's judgment or the site's clinical standard of care.
Folotyn decrease dose modifications will be made based on Hematologic Adverse Events (absolute neutrophil count) and Non- Hematologic Adverse events (CTCAE v.4) excluding nausea/vomiting for dose adjustments
|
Up to 8 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Gastrointestinal Diseases
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Gastroenteritis
- Stomatognathic Diseases
- Mouth Diseases
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Mucositis
- Physiological Effects of Drugs
- Protective Agents
- Antidotes
- Levoleucovorin
Other Study ID Numbers
- SPI-FUS-12-103
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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