Suspended
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)
What is being tested
Folotyn
+ Fusilev
+ Folotyn
Drug
Who is being recruted
Bronchial Neoplasms+7
+ Carcinoma, Bronchogenic
+ Lung Diseases
Over 18 Years
+15 Eligibility Criteria
How is the trial designed
Prevention Study
Phase 1
Interventional
Study Start: April 2013
Summary
Principal SponsorAcrotech Biopharma Inc.
Last updated: January 23, 2020
Sourced from a government-validated database.Claim as a partner
Study start date: April 1, 2013
Actual date on which the first participant was enrolled.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.
Principal SponsorAcrotech Biopharma Inc.
Last updated: January 23, 2020
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Prevention Study
Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Bronchial NeoplasmsCarcinoma, BronchogenicLung DiseasesLung NeoplasmsNeoplasmsNeoplasms by SiteRespiratory Tract DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsCarcinoma, Non-Small-Cell Lung
Criteria
6 inclusion criteria required to participate
Adequate hematological, hepatic, and renal function
At least 18 years of age
Available during the first 8 weeks of the study treatment period to visit the clinic for oral Mucositis assessments on scheduled days
Eastern Cooperative Oncology Group (ECOG) performance status <= 2
Show More Criteria
9 exclusion criteria prevent from participating
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
Active uncontrolled infection, underlying medical condition, or other serious illness that would impair the ability of the patient to receive protocol treatment
Congestive heart failure
Known human immunodeficiency virus (HIV)-positive diagnosis
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
5 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Experimental5 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
Group II
Experimental5 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
Group III
Experimental5 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
Group IV
Experimental5 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
Group 5
Experimental5 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
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has no location dataSave this study to your profile to know when the location data is available.
SuspendedNo study centers