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

Non-Small Cell Lung Cancer Clinical Trial

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)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01820091
• Other study ID #: SPI-FUS-12-103
• Status: Withdrawn
• Phase: Phase 1
• Start date: April 2013
• Est. completion date: April 2015

Study information

• Verified date: January 2020
• Source: Acrotech Biopharma LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Mucositis
• Non-Small Cell Lung Cancer

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Acrotech Biopharma LLC

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Up to 8 weeks
Secondary	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.	Up to 8 weeks
Secondary	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.	Up to 8 weeks
Secondary	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	Up to 8 weeks