A Bioequivalence Study of Vinorelbine Tartrate Injectable Emulsion in Patients With Advanced Cancer.
Information source: Adventrx Pharmaceuticals
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Breast Cancer; Non-Small Cell Lung Cancer; Non-Hodgkins Lymphoma
Intervention: Vinorelbine Tartrate (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Adventrx Pharmaceuticals
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.
Clinical Details
Official title: A Bioequivalence Study of Vinorelbine Tartrate Injectable Emulsion (ANX-530) in Patients With Advanced Cancer.
Study design: Randomized, Open Label, Dose Comparison, Crossover Assignment, Bio-equivalence Study
Primary outcome: Bioequivalence with reference product.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Clinical Investigative Site, Rosario, Argentina
Clinical Investigative Site, Tucuman, Argentina
Clinical Investigative Site, Santa Fe, Argentina
Clinical Investigative Site, Buenos Aires, Argentina
Clinical Investigative Site, Mendoza, Argentina
Additional Information
Starting date: February 2007
Last updated: November 15, 2007
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