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.”

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.

Intervention(s) in this Clinical Trial

• Drug: Vinorelbine Tartrate

Primary Measures

• Bioequivalence with reference product.

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 Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Adventrx Pharmaceuticals Industry

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00432562

Study ID Number: 530-01

ClinicalTrials.gov Identifier: NCT00432562

Health Authority: United States: Food and Drug Administration