Clinical trial · Interventional
A Bioequivalence Study of Vinorelbine Tartrate Injectable Emulsion in Patients With Advanced Cancer.
A Bioequivalence Study of Vinorelbine Tartrate Injectable Emulsion (ANX-530) in Patients With Advanced Cancer.
NCT00432562CI-TRIAL-00006324completedPhase 1Results postedClinicalTrials.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)
This study was a randomized, single dose crossover comparison of the investigational product with a Reference Product (vinorelbine tartrate injection, NAVELBINE®). The primary objective was to demonstrate the equivalence of ANX-530 and the Reference Product, NAVELBINE.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Non-Hodgkins Lymphoma | Non-Hodgkin Lymphoma | ALIAS | 0.90 |
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Vinorelbine Tartrate | Drug | Vinorelbine | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (10)
- measure
- Time to Reach Maximum Observed Plasma Concentration (Tmax)
- timeFrame
- 0-144 hours post dose
- measure
- Maximum Observed Plasma Concentration (Cmax)
- timeFrame
- 0-144 hours post-dose
- measure
- Area Under the Plasma Concentratio-Time Curve From Time 0 to the Time of the Last Measurable Concentration (AUClast)
- timeFrame
- 0-144 hours post-dose
- description
- Determined Using the Linear Trapezoidal Rule
- measure
- Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf)
- timeFrame
- 0-144 hours post-dose
- description
- AUCinf = AUClast + (Clast/lamda z)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age \> 18 years. * Advanced cancer potentially sensitive to vinorelbine: * Breast cancer. * Stage 3 or 4 non-small cell lung cancer. * Non-Hodgkins lymphoma. * Cancer of other histologic type, sensitive to vinca alkaloids. * Rare tumor type with no standard treatment, for which single agent vinorelbine is appropriate therapy. * Failure of standard treatment(s) of the tumor. * Life expectancy of at least three months. * ECOG performance level 0-2 or Karnofsky score 100-70. * Hematological and serum chemistry results with defined ranges. * Willingness and ability to provide written informed consent. Exclusion Criteria: * Pregnancy or lactation. In a woman of childbearing potential, a positive pregnancy test result, no pregnancy test result, or no use of reliable contraception, at baseline. A postmenopausal woman will be considered to be of childbearing potential until there has been amenorrhea for at least 12 consecutive months. * Previous treatment with vinorelbine or mitomycin. * Any history suggesting or demonstrating resistance to, lack of response to, or intolerance of any prior vinca alkaloid treatment. * Active infection. * Prior anticancer therapy completed within four weeks prior to the first day of study treatment. * Failure to have recovered from any toxicity of previous cancer treatment (patients with alopecia will not be excluded). * Participation in another experimental drug study within four weeks prior to the first day of study treatment. * Requirement for any concomitant chemotherapeutic agent other than the study medication. * Any investigator judgment that the individual would not be an appropriate study subject.
References
Publications (0)
Data not yet available
No reference posted for this study.