Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01820091
Recruitment Status : Withdrawn
First Posted : March 28, 2013
Last Update Posted : January 23, 2020
Sponsor:
Information provided by (Responsible Party):
Acrotech Biopharma LLC

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.

Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer Drug: Folotyn Drug: Fusilev Phase 1

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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 Start Date : April 2013
Estimated Primary Completion Date : April 2015
Estimated Study Completion Date : April 2015

Resource links provided by the National Library of Medicine


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

Drug: Folotyn
A cycle of Folotyn treatment is 28 days, with treatment on Days 1 and 15 in each cycle.
Other Name: Pralatrexate

Drug: Fusilev
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 Name: Levoleucovorin

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

Drug: Folotyn
A cycle of Folotyn treatment is 28 days, with treatment on Days 1 and 15 in each cycle.
Other Name: Pralatrexate

Drug: Fusilev
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 Name: Levoleucovorin

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

Drug: Folotyn
A cycle of Folotyn treatment is 28 days, with treatment on Days 1 and 15 in each cycle.
Other Name: Pralatrexate

Drug: Fusilev
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 Name: Levoleucovorin

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

Drug: Folotyn
A cycle of Folotyn treatment is 28 days, with treatment on Days 1 and 15 in each cycle.
Other Name: Pralatrexate

Drug: Fusilev
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 Name: Levoleucovorin

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

Drug: Folotyn
A cycle of Folotyn treatment is 28 days, with treatment on Days 1 and 15 in each cycle.
Other Name: Pralatrexate

Drug: Fusilev
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 Name: Levoleucovorin




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Layout table for additonal information
Responsible Party: Acrotech Biopharma LLC
ClinicalTrials.gov Identifier: NCT01820091    
Other Study ID Numbers: SPI-FUS-12-103
First Posted: March 28, 2013    Key Record Dates
Last Update Posted: January 23, 2020
Last Verified: January 2020
Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Mucositis
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases
Levoleucovorin
Antidotes
Protective Agents
Physiological Effects of Drugs