Phase 1
Completed N=31
A Bioequivalence Study of Vinorelbine Tartrate Injectable Emulsion in Patients With Advanced Cancer.
Source: ClinicalTrials.gov NCT00432562 ↗Enrolled (actual)
31
Serious AEs
19.4%
Results posted
Feb 2012
Primary outcomePrimary: Time to Reach Maximum Observed Plasma Concentration (Tmax) — 0.35; 0.34 hours
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Reach Maximum Observed Plasma Concentration (Tmax) |
0.35; 0.34 | — |
| PRIMARY Maximum Observed Plasma Concentration (Cmax) |
227; 223 | — |
| PRIMARY Area Under the Plasma Concentratio-Time Curve From Time 0 to the Time of the Last Measurable Concentration (AUClast) |
757.8; 716.1 | — |
| PRIMARY Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) |
810.1; 718.5 | — |
| PRIMARY Percentage of AUCinf Based on Extrapolation (AUCextrap) |
6.23; 4.72 | — |
| PRIMARY Observed Elimination Rate Constant Associated With the Terminal Portion of the Curve (λ z) |
0.0160; 0.0187 | — |
| PRIMARY Observed Terminal Elimination Half-Life (t1/2) |
46.50; 40.48 | — |
| PRIMARY Time of Last Measurable Concentration (Tlast) |
141.83; 141.79 | — |
| PRIMARY Last Quantifiable Drug Concentration (Clast) |
0.819; 0.824 | — |
| PRIMARY Mean Residence Time (MRTinf) |
35.39; 31.31 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00432562). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.