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

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mast Therapeutics, Inc.
• Collaborators: OCASA Soluciones Logísticas S.A.; Synteract, Inc.; Thywill Latam Solutions SRL; Worldwide Clinical Trials
• Treatments: Vinblastine; Vinorelbine

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.