A Bioequivalence Study of Vinorelbine Tartrate Injectable Emulsion in Patients With Advanced Cancer. - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information
First Received Date ^†	February 6, 2007
Last Updated Date	November 15, 2007
Start Date ^†	February 2007
Current Primary Outcome Measures ^† (submitted: February 7, 2007)	Bioequivalence with reference product.
Original Primary Outcome Measures ^†	Same as current
Change History	Complete list of historical versions of study NCT00432562 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^†
Original Secondary Outcome Measures ^†

Descriptive Information
Brief Title ^†	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.
Brief Summary	This study is a randomized, single dose crossover comparison of the investigational product with a Reference Product (vinorelbine tartrate injection, NAVELBINE®). The primary objective is to demonstrate the equivalence of ANX-530 and the Reference Product, NAVELBINE.
Detailed Description
Study Phase	Phase I
Study Type ^†	Interventional
Study Design ^†	Randomized, Open Label, Dose Comparison, Crossover Assignment, Bio-equivalence Study
Condition ^†	Breast Cancer Non-Small Cell Lung Cancer Non-Hodgkins Lymphoma
Intervention ^†	Drug: Vinorelbine Tartrate
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^†	Completed
Enrollment ^†	28
Completion Date
Primary Completion Date
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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^††
Location Countries ^†	Argentina
Expanded Access Status

Administrative Information
NCT ID ^†	NCT00432562
Responsible Party
Secondary IDs ^††
Study Sponsor ^†	Adventrx Pharmaceuticals
Collaborators ^††
Investigators ^†
Information Provided By	Adventrx Pharmaceuticals
Verification Date	November 2007
^† Required WHO trial registration data element. ^†† WHO trial registration data element that is required only if it exists.