NCT00432562

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 demonstrate the equivalence of ANX-530 and the Reference Product, NAVELBINE.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for phase_1 breast-cancer

Timeline
Completed

Started Feb 2007

Shorter than P25 for phase_1 breast-cancer

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

February 6, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 8, 2007

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
4.2 years until next milestone

Results Posted

Study results publicly available

February 23, 2012

Completed
Last Updated

February 23, 2012

Status Verified

January 1, 2012

Enrollment Period

9 months

First QC Date

February 6, 2007

Results QC Date

January 19, 2012

Last Update Submit

January 19, 2012

Conditions

Breast CancerNon-small Cell Lung CancerNon-Hodgkins Lymphoma

Outcome Measures

Primary Outcomes (10)

  • Time to Reach Maximum Observed Plasma Concentration (Tmax)

    0-144 hours post dose

  • Maximum Observed Plasma Concentration (Cmax)

    0-144 hours post-dose

  • Area Under the Plasma Concentratio-Time Curve From Time 0 to the Time of the Last Measurable Concentration (AUClast)

    Determined Using the Linear Trapezoidal Rule

    0-144 hours post-dose

  • Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf)

    AUCinf = AUClast + (Clast/lamda z)

    0-144 hours post-dose

  • Percentage of AUCinf Based on Extrapolation (AUCextrap)

    0-144 hours post-dose

  • Observed Elimination Rate Constant Associated With the Terminal Portion of the Curve (λ z)

    Estimated via linear regression of the time versus log concentration

    0-144 hours post-dose

  • Observed Terminal Elimination Half-Life (t1/2)

    t1/2 = \[ln(2)/λ z\]

    0-144 hours post-dose

  • Time of Last Measurable Concentration (Tlast)

    0-144 hours post-dose

  • Last Quantifiable Drug Concentration (Clast)

    0-144 hours post-dose

  • Mean Residence Time (MRTinf)

    MRT = (AUMCinf)/(AUCinf)

    0-144 hours post-dose

Interventions

Vinorelbine TartrateDRUG

Subjects received one dose each of ANX-530 and NAVELBINE, each providing 30 mg/m2 vinorelbine. Study drugs will be infused into an arm vein over ten minutes.

Also known as: Exelbine (proposed), ANX-530

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Clinical Investigative Site

Buenos Aires, Argentina

Location

Clinical Investigative Site

Mendoza, Argentina

Location

Clinical Investigative Site

Rosario, Argentina

Location

Clinical Investigative Site

San Miguel de Tucumán, Argentina

Location

Clinical Investigative Site

Santa Fe, Argentina

Location

MeSH Terms

Conditions

Breast NeoplasmsCarcinoma, Non-Small-Cell LungLymphoma, Non-Hodgkin

Interventions

Vinorelbine

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesCarcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesLymphomaNeoplasms by Histologic TypeLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Vinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizines

Results Point of Contact

Title
Chief Executive Officer
Organization
Adventrx Pharmaceuticals
culley@adventrx.com
858-768-6325

Study Officials

  • Lino Arboit, M.D.

    Fundación Centro Oncológico de Integración Regional - COIR.

    PRINCIPAL INVESTIGATOR

  • Gerardo F Arroyo, M.D.

    Hospital Privado De Santa Clara De Asis

    PRINCIPAL INVESTIGATOR

  • Cesar R Blajman, M.D.

    Isis Clínica Especializada

    PRINCIPAL INVESTIGATOR

  • Matias Chacon, M.D.

    Instituto Médico Espcializado Alexander Fleming

    PRINCIPAL INVESTIGATOR

  • Luis E Fein, M.D.

    Centro Oncológico

    PRINCIPAL INVESTIGATOR

  • Hugo R. Requejo, M.D.

    Hospital Regional De Concepción

    PRINCIPAL INVESTIGATOR

  • Edgar P Quintana, M.D.

    CIMA Salud

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 6, 2007

First Posted

February 8, 2007

Study Start

February 1, 2007

Primary Completion

November 1, 2007

Study Completion

December 1, 2007

Last Updated

February 23, 2012

Results First Posted

February 23, 2012

Record last verified: 2012-01

Locations

AR(5)