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

Primary Purpose

Non-Small Cell Lung Cancer

Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Folotyn
Fusilev
Sponsored by
Acrotech Biopharma Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Non-Small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    Cohort 1 - Fusilev - 20 doses

    Cohort 2 - Fusilev - 12 doses

    Cohort 3 - Fusilev - 8 doses

    Cohort 4 - Fusilev - 4 doses

    Cohort 5 - Fusilev - 2 doses

    Arm 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

    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

    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

    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

    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

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Impact of Fusilev on the number of Folotyn-related dose modifications secondary to oral mucositis
    Analysis will involve the number, percent and type of Folotyn dose modification as a function of Fusilev dose.
    Impact of Fusilev on the frequency of Oral Mucositis
    Distribution of the number of cases of oral mucositis will be described by cohort and by degree of mucositis.
    Impact of Fusilev on use of Analgesics for Oral Mucositis
    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.
    Impact of Fusilev on number of Folotyn doses delivered
    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

    Full Information

    First Posted
    March 21, 2013
    Last Updated
    January 21, 2020
    Sponsor
    Acrotech Biopharma Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01820091
    Brief Title
    Phase 1 Study of Fusilev® to Prevent or Reduce Mucositis in Patients With Non-Small Cell Lung Cancer Receiving Folotyn®
    Official Title
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2020
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    April 2013 (undefined)
    Primary Completion Date
    April 2015 (Anticipated)
    Study Completion Date
    April 2015 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Acrotech Biopharma Inc.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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-related Grade 3 or higher oral mucositis.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Non-Small Cell Lung Cancer

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Cohort 1 - Fusilev - 20 doses
    Arm Type
    Experimental
    Arm 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
    Arm Title
    Cohort 2 - Fusilev - 12 doses
    Arm Type
    Experimental
    Arm 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
    Arm Title
    Cohort 3 - Fusilev - 8 doses
    Arm Type
    Experimental
    Arm 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
    Arm Title
    Cohort 4 - Fusilev - 4 doses
    Arm Type
    Experimental
    Arm 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
    Arm Title
    Cohort 5 - Fusilev - 2 doses
    Arm Type
    Experimental
    Arm 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
    Intervention Type
    Drug
    Intervention Name(s)
    Folotyn
    Other Intervention Name(s)
    Pralatrexate
    Intervention Description
    A cycle of Folotyn treatment is 28 days, with treatment on Days 1 and 15 in each cycle.
    Intervention Type
    Drug
    Intervention Name(s)
    Fusilev
    Other Intervention Name(s)
    Levoleucovorin
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Optimal dose and Schedule of Fusilev to prevent or reduce Oral Mucositis
    Description
    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.
    Time Frame
    Up to 8 weeks
    Secondary Outcome Measure Information:
    Title
    Impact of Fusilev on the number of Folotyn-related dose modifications secondary to oral mucositis
    Description
    Analysis will involve the number, percent and type of Folotyn dose modification as a function of Fusilev dose.
    Time Frame
    Up to 8 weeks
    Title
    Impact of Fusilev on the frequency of Oral Mucositis
    Description
    Distribution of the number of cases of oral mucositis will be described by cohort and by degree of mucositis.
    Time Frame
    Up to 8 weeks
    Title
    Impact of Fusilev on use of Analgesics for Oral Mucositis
    Description
    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.
    Time Frame
    Up to 8 weeks
    Title
    Impact of Fusilev on number of Folotyn doses delivered
    Description
    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
    Time Frame
    Up to 8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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

    12. IPD Sharing Statement

    Learn more about this trial

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

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