Safety Study of Oral Vinorelbine in Subjects With Non-Hematologic Malignancies

Study Overview
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Brief Summary
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The purpose of this study is to determine the safety of oral administration of vinorelbine once daily for at least 7 days. The study will be conducted in subjects with a non-hematologic malignancy for which there are no currently accepted therapies.

Official Title
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A Phase 1 Study of the Safety, Pharmacokinetics, and Biological Activity of Metronomic Dosing With Orally Administered Vinorelbine Tablets in Subjects With Non-Hematologic Malignancies For Which There Are No Currently Accepted Therapies

Conditions
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Nonhematologic Malignancies

Intervention / Treatment
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* Drug: vinorelbine tartrate
* Drug: vinorelbine tartrate
* Drug: vinorelbine tartrate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: capable of understanding study requirements and able to provide Informed Consent diagnosed with a non-hematologic malignancy for which there are no currently accepted therapies life expectancy at least 3 months agreement to use medically acceptable contraception throughout the study willing and able to comply with the protocol requirements Exclusion Criteria: currently receiving systemic treatment for malignancy not yet recovered from the toxicity of prior therapies platelet count < 100,000 cells/mm3 within 7 days prior to study entry ANC < 1500 cells/mm3 within 7 days prior to study entry hemoglobin < 8.5 g/dL within 7 days prior to study entry AST and/or ALT > 2.5 X ULN within 7 days prior to study entry total bilirubin > 1.5 X ULN within 7 days prior to study entry creatinine clearance < 60 mL/min (Cockroft-Gault formula) within 7 days prior to study entry receipt of any investigational therapy within 3 weeks prior to study entry known history of HIV, HBV, and/or HCV infection clinically relevant active infection or serious co-morbid medical condition at study entry major surgery within 4 weeks prior to study entry other malignancy within 3 year prior to study entry pregnant or breast-feeding presence of a concomitant disease or condition which, in the opinion of the Investigator, could interfere with the conduct of the study or could put the subject at unacceptable risk

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br> | Drug: vinorelbine tartrate<br>* Dose Level #1 PO for at least 7 days<br>|
| Experimental: Cohort 2<br> | Drug: vinorelbine tartrate<br>* Dose Level #2 PO for at least 7 days<br>|
| Experimental: Cohort 3<br> | Drug: vinorelbine tartrate<br>* Dose Level #3 PO for at least 7 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety as measured by adverse events, physical examinations, clinical laboratory assessments, and vital signs |  | Assessed at each subject visit to the study center | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics of orally administered vinorelbine |  | Samples collected on Study Days 1, 2, and 8 | 
| Exploratory analysis of blood markers of biological activity |  | Blood samples collected at selected subject visits to the study center | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vinorelbine, metronomic dosing, oral administration, nonhematologic malignancies, pharmacokinetics