Clinical trial · Interventional
Safety Study of Oral Vinorelbine in Subjects With Non-Hematologic Malignancies
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
NCT00641160CI-TRIAL-00001701unknownPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Nonhematologic Malignancies | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| vinorelbine tartrate | Drug | Vinorelbine | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Cohort 1
- interventionNames
- Drug: vinorelbine tartrate
- type
- EXPERIMENTAL
- label
- Cohort 2
- interventionNames
- Drug: vinorelbine tartrate
- type
- EXPERIMENTAL
- label
- Cohort 3
- interventionNames
- Drug: vinorelbine tartrate
Primary outcomes (1)
- measure
- Safety as measured by adverse events, physical examinations, clinical laboratory assessments, and vital signs
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.