Non-Small Cell Lung CancerPhase 2NCT00251446
A Phase II Single Arm Trial of Single-agent Vinflunine as Second-line Treatment of Advanced Non-Small Cell Lung Cancer
A Phase 2 study testing Vinflunine in people with Non-Small Cell Lung Cancer, run by Veeda Oncology at 1 site in United States.
Trial summary
This is a Phase II, single-arm study in patients with stage IIIB (with malignant pleural effusion) and IV NSCLC who have been previously treated with a platinum-based doublet. Each cycle will be 21 days. On Day 1 of each cycle, patients will receive vinflunine 320 mg/m2 as a 20-minute IV infusion. 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?
- Vinflunine
- Type of treatment
- Injection or infusion
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2005to Mar 2008
- Phase
- Phase 2
- 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
- To be eligible for the study, patients must fulfill all of the following criteria:
- Patients must have signed an IRB-approved informed consent.
- Patients must have recurrent or metastatic stage IIIB (with malignant pleural effusion) and IV NSCLC that has progressed after receiving a platinum-based doublet as first-line therapy.
- Patients must have measurable disease, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Previously irradiated lesions will not be allowed as measurable disease.
- Patients must have an ECOG Performance Status of 0, 1, or 2.
- Patients must be <18 years of age.
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- Previous chemotherapy must have been completed at least 4 weeks prior to enrollment.
- Patients must either be not of child bearing potential or have a negative serum pregnancy test within 7 days prior to registration. Patients are considered not of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or they are postmenopausal for at least 12 months.
- Patients of childbearing potential must agree to use effective contraceptive measures during study treatment and for a reasonable time thereafter.
- Patients must have an absolute neutrophil count (ANC) >1500/uL, platelet count >100,000/uL, and hemoglobin >8 g/dL.
- Patients must have a serum creatinine <2 x institutional upper limit of normal (ULN).
- Patients must have a total bilirubin <2.5 x ULN and aspartate transaminase (AST) <5.0 x ULN.
Who cannot join
- Any of the following criteria will make the patient ineligible to participate in this study:
- Patients previously treated with vinflunine or another vinca alkaloid.
- Patients with untreated and clinically unstable brain metastases.
- Significant history of uncontrolled cardiac disease; i.e., uncontrolled hypertension, unstable angina, recent myocardial infarction (within prior 6 months), uncontrolled congestive heart failure, and cardiomyopathy with decreased ejection fraction.
- Patients with a serious uncontrolled intercurrent medical or psychiatric illness, including serious infection.
- Patient has a co-existing malignancy or had a malignancy diagnosed within the last 3 years, with the exception of basal cell carcinoma or cervical cancer in situ.
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- Patient received treatment with a non-approved or investigational drug within 30 days before planned start of study treatment.
- Patient is not completely healed from a previous oncologic or other major surgery.
- Patient is receiving or planning to receive any concurrent chemotherapy not indicated in the study protocol or an investigational agent during the study period.
- Patients who have a history of hypersensitivity to vinflunine or any of the components in vinflunine or another vinca alkaloid.
- Any patient who is pregnant or lactating.
- Any patient who is unable to comply with requirements of study.
Trial locations and contacts
1 site in 1 country.
About this study
This is a Phase II, single-arm study in patients with stage IIIB (with malignant pleural effusion) and IV NSCLC who have been previously treated with a platinum-based doublet.
Each cycle will be 21 days. On Day 1 of each cycle, patients will receive vinflunine 320 mg/m2 as a 20-minute IV infusion.
Patients will continue to receive study treatment until disease progression or unacceptable toxicity.
Patients will be evaluated every 2 cycles for response using RECIST criteria.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- Vinflunine
- 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.
VinflunineDrug
320 mg/m2 as a 20-minute IV infusion
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the 1-year survival rate in patients with stage IIIB-IV NSCLC receiving single-agent vinflunine who were previously treated with a platinum-based doublet.
Measured: unk
Secondary outcomes (7)
To assess response rate (RR) of single-agent vinflunine in patients with stage IIIB-IV NSCLC who were previously treated with a platinum-based doublet.
Measured: unk
To assess overall survival in patients with stage IIIB-IV NSCLC receiving single-agent vinflunine who were previously treated with a platinum-based doublet.
Measured: unk
To determine the progression-free survival (PFS) in patients with stage IIIB-IV NSCLC receiving single-agent vinflunine who were previously treated with a platinum-based doublet
Measured: unk
To assess time to response (TTR) in patients with stage IIIB-IV NSCLC receiving single-agent vinflunine who were previously treated with a platinum-based doublet.
Measured: unk
To assess duration of overall response in patients with stage IIIB-IV NSCLC receiving single-agent vinflunine who were previously treated with a platinum-based doublet.
Measured: unk
To assess duration of stable disease in patients with stage IIIB-IV NSCLC receiving single-agent vinflunine who were previously treated with a platinum-based doublet.
Measured: unk
To assess the safety of single-agent vinflunine in patients with stage IIIB-IV NSCLC who were previously treated with a platinum-based doublet.
Measured: unk
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2005 (estimated)
- Study startOct 2005
- Primary completionMar 2008
- Study completionMar 2008
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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Veeda Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- Marcos Joppert, MD, Principal investigator, Veeda Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00251446
- Sponsor's protocol ID
- I-05-009
- Status last verified
- May 2012
- First submitted
- 8 Nov 2005
- Last updated
- 11 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Single Arm Trial of Single-agent Vinflunine as Second-line Treatment of Advanced Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00251446
- Acronym / sponsor ID
- I-05-009
- Conditions
- Non-Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Veeda OncologyUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- Oct 2005
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 10 Nov 2005 (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.
This is a Phase II, single-arm study in patients with stage IIIB (with malignant pleural effusion) and IV NSCLC who have been previously treated with a platinum-based doublet.
Each cycle will be 21 days. On Day 1 of each cycle, patients will receive vinflunine 320 mg/m2 as a 20-minute IV infusion.
Patients will continue to receive study treatment until disease progression or unacceptable toxicity.
Patients will be evaluated every 2 cycles for response using RECIST criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients must have signed an IRB-approved informed consent.
- Patients must have recurrent or metastatic stage IIIB (with malignant pleural effusion) and IV NSCLC that has progressed after receiving a platinum-based doublet as first-line therapy.
- Patients must have measurable disease, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Previously irradiated lesions will not be allowed as measurable disease.
- Patients must have an ECOG Performance Status of 0, 1, or 2.
- Patients must be <18 years of age.
Key exclusion criteria (12 listed)
- Any of the following criteria will make the patient ineligible to participate in this study:
- Patients previously treated with vinflunine or another vinca alkaloid.
- Patients with untreated and clinically unstable brain metastases.
- Significant history of uncontrolled cardiac disease; i.e., uncontrolled hypertension, unstable angina, recent myocardial infarction (within prior 6 months), uncontrolled congestive heart failure, and cardiomyopathy with decreased ejection fraction.
- Patients with a serious uncontrolled intercurrent medical or psychiatric illness, including serious infection.
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 |
|---|---|---|
| Vinflunine320 mg/m2 as a 20-minute IV infusion | Drug | – |
Primary outcome
To determine the 1-year survival rate in patients with stage IIIB-IV NSCLC receiving single-agent vinflunine who were previously treated with a platinum-based doublet.
Time frame: unk
7 secondary outcomes
To assess response rate (RR) of single-agent vinflunine in patients with stage IIIB-IV NSCLC who were previously treated with a platinum-based doublet.
Time frame: unk
To assess overall survival in patients with stage IIIB-IV NSCLC receiving single-agent vinflunine who were previously treated with a platinum-based doublet.
Time frame: unk
To determine the progression-free survival (PFS) in patients with stage IIIB-IV NSCLC receiving single-agent vinflunine who were previously treated with a platinum-based doublet
Time frame: unk
To assess time to response (TTR) in patients with stage IIIB-IV NSCLC receiving single-agent vinflunine who were previously treated with a platinum-based doublet.
Time frame: unk
To assess duration of overall response in patients with stage IIIB-IV NSCLC receiving single-agent vinflunine who were previously treated with a platinum-based doublet.
Time frame: unk
To assess duration of stable disease in patients with stage IIIB-IV NSCLC receiving single-agent vinflunine who were previously treated with a platinum-based doublet.
Time frame: unk
To assess the safety of single-agent vinflunine in patients with stage IIIB-IV NSCLC who were previously treated with a platinum-based doublet.
Time frame: unk
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2012.
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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.
Marcos Joppert, MD principal investigator
Veeda Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vinflunine in people with Non-Small Cell Lung Cancer, run by Veeda Oncology at 1 site in United States.
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 12 inclusion and 12 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: finished, as of the sponsor's last update on 11 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To determine the 1-year survival rate in patients with stage IIIB-IV NSCLC receiving single-agent vinflunine who were previously treated with a platinum-based doublet. (time frame: unk). 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 11 May 2012; AzTrials last refreshed its copy on 7 Nov 2026.