Status:
COMPLETED
A Bioequivalence Study of Vinorelbine Tartrate Injectable Emulsion in Patients With Advanced Cancer.
Lead Sponsor:
Mast Therapeutics, Inc.
Collaborating Sponsors:
Synteract, Inc.
Thywill Latam Solutions SRL
Conditions:
Breast Cancer
Non-small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 demonst...
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 solutio...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT00432562
Start Date
February 1 2007
End Date
December 1 2007
Last Update
February 23 2012
Active Locations (5)
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1
Clinical Investigative Site
Buenos Aires, Argentina
2
Clinical Investigative Site
Mendoza, Argentina
3
Clinical Investigative Site
Rosario, Argentina
4
Clinical Investigative Site
San Miguel de Tucumán, Argentina