A Phase 2 interventional study of Vinflunine in Carcinoma, Small Cell and Lung Cancer, sponsored by SCRI Development Innovations, LLC. Completed at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-03-13.
Sponsored by SCRI Development Innovations, LLC · Phase 2, Interventional, and Treatment
This clinical trial involves the administration of the chemotherapeutic medication vinflunine. Vinflunine is not approved by the FDA and is experimental in the treatment of extensive small cell lung cancer. The purpose of this research trial is to study the effectiveness of vinflunine in patients with relapsed extensive small cell lung cancer, evaluate the toxicity, and evaluate how long the response to this drug lasts.
Eligible patients will receive vinflunine as a 15-20 minute intravenous (IV)infusion once every three weeks (21 days). This three week treatment period is called a cycle. Patients whose cancer has not grown or if it has decreased in size may receive up to 6 cycles of vinflunine. Evaluation will be conducted every other cycle.
103 studies on the registry are indexed under Carcinoma, Small Cell; 14 are open to participants now.
This study's enrollment of 51 is above the median of 40 across 85 interventional studies indexed under Carcinoma, Small Cell.
Browse Carcinoma, Small Cell studies →SCRI Development Innovations, LLC is the lead sponsor of 179 studies on the registry; 5 are open to participants now.
Of its 15 completed or terminated interventional studies of FDA-regulated products, 15 (100%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients received vinflunine 320 mg/m2 every 21 days as a 15- to 20-minute infusion.
Drug: Vinflunine
320mg/m2 every 21 days as a 15-20 minute infusion
Also known as: Javlor
Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment
Overall response rate is the percentage of patients with complete response or partial response per RECIST v.1 Criteria. Complete response (CR) = Disappearance of all target lesions, disappearance of all nontarget lesions for at least 4 weeks. Partial Response (PR) = At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameters. The final response criteria assigned represented the best response obtained during treatment.
Time frame: 18 months
Duration of Response, the Length of Time, in Months, That Protocol Treatment Produced an Objective Improvement in Patients' Disease
The Response Duration was calculated from time of initial measured response to date of first observation of progressive disease.
Time frame: 18 months
Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death
Overall survival was measured from the date of study entry until the date of death.
Time frame: 18 months
Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease
Progression free survival was defined as the interval between the start date of treatment and the date of occurrence of progressive disease or death.
Time frame: 18 months
| Milestone | Vinflunine |
|---|---|
| Started | 51 |
| Completed | 9 |
| Not completed | 42 |
Overall response rate is the percentage of patients with complete response or partial response per RECIST v.1 Criteria. Complete response (CR) = Disappearance of all target lesions, disappearance of all nontarget lesions for at least 4 weeks. Partial Response (PR) = At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameters. The final response criteria assigned represented the best response obtained during treatment.
| percentage of participants | Vinflunine |
|---|---|
| Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment | 19.6 (10 to 33) |
The Response Duration was calculated from time of initial measured response to date of first observation of progressive disease.
| Months | Vinflunine |
|---|---|
| Duration of Response, the Length of Time, in Months, That Protocol Treatment Produced an Objective Improvement in Patients' Disease | 2.7 (1.9 to 3.9) |
Overall survival was measured from the date of study entry until the date of death.
| Months | Vinflunine |
|---|---|
| Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death | 4.9 (3.2 to 6.5) |
Progression free survival was defined as the interval between the start date of treatment and the date of occurrence of progressive disease or death.
| Months | Vinflunine |
|---|---|
| Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease | 1.6 (1.3 to 3.9) |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Vinflunine | — | 31/51 (60.8%) | 30/51 (58.8%) |
| Event | Vinflunine |
|---|---|
| Death not associated with CTCAE term - Disease Progression NOSGeneral disorders | 11/51 |
| NeutrophilsBlood and lymphatic system disorders | 4/51 |
| Febrile NeutropeniaInfections and infestations | 2/51 |
| HemoglobinBlood and lymphatic system disorders | 2/51 |
| Infection - Other (Pneumonia)Infections and infestations | 2/51 |
| Pain - abdomenGastrointestinal disorders | 2/51 |
| LeukocytesBlood and lymphatic system disorders | 2/51 |
| PlateletsBlood and lymphatic system disorders | 2/51 |
| ConstipationGastrointestinal disorders | 1/51 |
| DiarrheaGastrointestinal disorders | 1/51 |
| Event | Vinflunine |
|---|---|
| ConstipationGastrointestinal disorders | 30/51 |
| FatigueGeneral disorders | 30/51 |
| HemoglobinBlood and lymphatic system disorders | 28/51 |
| NauseaGastrointestinal disorders | 24/51 |
| NeutropeniaBlood and lymphatic system disorders | 21/51 |
| DyspneaRespiratory, thoracic and mediastinal disorders | 19/51 |
| AnorexiaGastrointestinal disorders | 16/51 |
| VomitingGastrointestinal disorders | 16/51 |
| LeukopeniaBlood and lymphatic system disorders | 15/51 |
| DiarrheaGastrointestinal disorders | 12/51 |
| Age, Categorical(Participants) | Vinflunine |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 33 |
| >=65 years | 18 |
| Age Continuous(years) | Vinflunine |
|---|---|
| Mean | 61 ± 10.1 |
| Sex: Female, Male(Participants) | Vinflunine |
|---|---|
| Female | 23 |
| Male | 28 |
| Region of Enrollment(participants) | Vinflunine |
|---|---|
| United States | 51 |
The record gives a start of Jan 2006, a primary completion of May 2009 and a completion of Nov 2009. It does not say whether these dates are actual or estimated.
Results were first posted in Mar 2013, 3 years 10 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Vinflunine
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