NCT01820091View on ClinicalTrials.gov

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

PHASE1WithdrawnINTERVENTIONAL

Timeline

Start Date

April 30, 2013

Primary Completion Date

April 30, 2015

Study Completion Date

April 30, 2015

Conditions

Non-Small Cell Lung Cancer

Interventions

DRUG

Folotyn

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

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.