Clinical trial NCT00432562: A Bioequivalence Study of Vinorelbine Tartrate Injectable Emulsion in Patients With Advanced Cancer.
Official title: A Bioequivalence Study of Vinorelbine Tartrate Injectable Emulsion (ANX-530) in Patients With Advanced Cancer.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Breast Cancer
Non-small Cell Lung Cancer
Non-Hodgkins Lymphoma
Lead sponsor: Mast Therapeutics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Synteract, Inc.
name: Thywill Latam Solutions SRL
name: OCASA Soluciones Logísticas S.A.
name: Worldwide Clinical Trials
First posted: 2007-02-08
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

Detailed description: ANX-530 (vinorelbine tartrate injectable emulsion), an investigational drug, is an oil-in-water emulsion of vinorelbine tartrate composed of an oil phase and emulsifier dispersed in an aqueous solution. ADVENTRX Pharmaceuticals, Inc. of San Diego, California, developed ANX-530 as a vinorelbine tartrate formulation to be used in clinical settings where Vinorelbine Tartrate Injection (NAVELBINE) is indicated. Nonclinical toxicology studies suggest either equivalent or less toxicity of ANX-530 compared to Reference Product. In particular, ANX-530 caused less vein toxicity in a rabbit vein irritation model, suggesting ANX-530 could potentially cause less venous irritation than NAVELBINE in a clinical setting. ADVENTRX is investigating whether ANX-530 could substitute for NAVELBINE in these settings.

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.

Primary outcomes:
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
measure: Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf)
timeFrame: 0-144 hours post-dose
measure: Percentage of AUCinf Based on Extrapolation (AUCextrap)
timeFrame: 0-144 hours post-dose
measure: Observed Elimination Rate Constant Associated With the Terminal Portion of the Curve (λ z)
timeFrame: 0-144 hours post-dose
measure: Observed Terminal Elimination Half-Life (t1/2)
timeFrame: 0-144 hours post-dose
measure: Time of Last Measurable Concentration (Tlast)
timeFrame: 0-144 hours post-dose
measure: Last Quantifiable Drug Concentration (Clast)
timeFrame: 0-144 hours post-dose
measure: Mean Residence Time (MRTinf)
timeFrame: 0-144 hours post-dose
Secondary outcomes:
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Clinical Investigative Site
city: Mendoza
country: Argentina
facility: Clinical Investigative Site
city: Rosario
country: Argentina
facility: Clinical Investigative Site
city: Santa Fe
country: Argentina
facility: Clinical Investigative Site
city: Tucuman
country: Argentina
facility: Clinical Investigative Site
Study officials:
affiliation: Fundación Centro Oncológico de Integración Regional - COIR.
name: Lino Arboit, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Privado De Santa Clara De Asis
name: Gerardo F Arroyo, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Isis Clínica Especializada
name: Cesar R Blajman, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto Médico Espcializado Alexander Fleming
name: Matias Chacon, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Centro Oncológico
name: Luis E Fein, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Regional De Concepción
name: Hugo R. Requejo, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: CIMA Salud
name: Edgar P Quintana, M.D.
role: PRINCIPAL_INVESTIGATOR
References: