Non-Small Cell Lung CancerPhase 1NCT01820091
Phase 1 Study of Fusilev® to Prevent or Reduce Mucositis in Patients With Non-Small Cell Lung Cancer Receiving Folotyn®
A Phase 1 study testing Folotyn and Fusilev in people with Non-Small Cell Lung Cancer, run by Acrotech Biopharma Inc..
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- Folotyn and Fusilev
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2013to Apr 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
About this study
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)
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.
Read the 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.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- Folotyn, Fusilev
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FolotynDrug
Also called Pralatrexate
A cycle of Folotyn treatment is 28 days, with treatment on Days 1 and 15 in each cycle.
FusilevDrug
Also called Levoleucovorin
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.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 - Fusilev - 20 doses | Experimental | 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 Receives: Drug: Folotyn; Drug: Fusilev |
| Cohort 2 - Fusilev - 12 doses | Experimental | 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 Receives: Drug: Folotyn; Drug: Fusilev |
| Cohort 3 - Fusilev - 8 doses | Experimental | 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 Receives: Drug: Folotyn; Drug: Fusilev |
| Cohort 4 - Fusilev - 4 doses | Experimental | 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 Receives: Drug: Folotyn; Drug: Fusilev |
| Cohort 5 - Fusilev - 2 doses | Experimental | 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 Receives: Drug: Folotyn; Drug: Fusilev |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 8 weeks
Secondary outcomes (4)
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.
Measured: Up to 8 weeks
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.
Measured: Up to 8 weeks
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.
Measured: Up to 8 weeks
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
Measured: Up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2013 (estimated)
- Study startApr 2013
- Primary completionApr 2015 (estimated)
- Study completionApr 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acrotech Biopharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01820091
- Sponsor's protocol ID
- SPI-FUS-12-103
- Status last verified
- Jan 2020
- First submitted
- 21 Mar 2013
- Last updated
- 23 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01820091
- Acronym / sponsor ID
- SPI-FUS-12-103
- Conditions
- Non-Small Cell Lung Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Acrotech Biopharma Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Apr 2015 (estimated)
- Study completion
- Apr 2015 (estimated)
- First posted
- 28 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 - Fusilev - 20 doses | Experimental | Drug: Folotyn, Drug: Fusilev5 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 |
| Cohort 2 - Fusilev - 12 doses | Experimental | Drug: Folotyn, Drug: Fusilev5 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 |
| Cohort 3 - Fusilev - 8 doses | Experimental | Drug: Folotyn, Drug: Fusilev5 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 |
| Cohort 4 - Fusilev - 4 doses | Experimental | Drug: Folotyn, Drug: Fusilev5 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 |
| Cohort 5 - Fusilev - 2 doses | Experimental | Drug: Folotyn, Drug: Fusilev5 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FolotynAlso: PralatrexateA cycle of Folotyn treatment is 28 days, with treatment on Days 1 and 15 in each cycle. | Drug | Cohort 1 - Fusilev - 20 doses, Cohort 2 - Fusilev - 12 doses, Cohort 3 - Fusilev - 8 doses, Cohort 4 - Fusilev - 4 doses, Cohort 5 - Fusilev - 2 doses |
| FusilevAlso: LevoleucovorinFusilev 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. | Drug | Cohort 1 - Fusilev - 20 doses, Cohort 2 - Fusilev - 12 doses, Cohort 3 - Fusilev - 8 doses, Cohort 4 - Fusilev - 4 doses, Cohort 5 - Fusilev - 2 doses |
Primary outcome
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.
4 secondary outcomes
Impact of Fusilev on the number of Folotyn-related dose modifications secondary to oral mucositis
Time frame: Up to 8 weeks
Impact of Fusilev on the frequency of Oral Mucositis
Time frame: Up to 8 weeks
Impact of Fusilev on use of Analgesics for Oral Mucositis
Time frame: Up to 8 weeks
Impact of Fusilev on number of Folotyn doses delivered
Time frame: Up to 8 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Folotyn and Fusilev in people with Non-Small Cell Lung Cancer, run by Acrotech Biopharma Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 23 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Optimal dose and Schedule of Fusilev to prevent or reduce Oral Mucositis (time frame: Up to 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2020.