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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)


Phase 1
18 Years
N/A
Not Enrolling
Both
Non-Small Cell Lung Cancer

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Trial Information

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)


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Optimal dose and Schedule of Fusilev to prevent or reduce Oral Mucositis

Outcome 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.

Outcome Time Frame:

Up to 8 weeks

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

SPI-FUS-12-103

NCT ID:

NCT01820091

Start Date:

April 2013

Completion Date:

April 2015

Related Keywords:

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

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