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

Primary Purpose

Breast Cancer, Non-small Cell Lung Cancer, Non-Hodgkins Lymphoma

Status

Completed

Phase

Phase 1

Locations

Argentina

Study Type

Interventional

Intervention

Vinorelbine Tartrate

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Clinical Investigative Site
Clinical Investigative Site
Clinical Investigative Site
Clinical Investigative Site
Clinical Investigative Site

Outcomes

Primary Outcome Measures

Time to Reach Maximum Observed Plasma Concentration (Tmax)

Maximum Observed Plasma Concentration (Cmax)

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

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

AUCinf = AUClast + (Clast/lamda z)

Percentage of AUCinf Based on Extrapolation (AUCextrap)

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

Estimated via linear regression of the time versus log concentration

Observed Terminal Elimination Half-Life (t1/2)

t1/2 = [ln(2)/λ z]

Time of Last Measurable Concentration (Tlast)

Last Quantifiable Drug Concentration (Clast)

Mean Residence Time (MRTinf)

MRT = (AUMCinf)/(AUCinf)

Secondary Outcome Measures

Full Information

NCT ID

NCT00432562

First Posted

February 6, 2007

Last Updated

January 19, 2012

Sponsor

Mast Therapeutics, Inc.

Collaborators

Synteract, Inc., Thywill Latam Solutions SRL, OCASA Soluciones Logísticas S.A., Worldwide Clinical Trials

1. Study Identification

Unique Protocol Identification Number

NCT00432562

Brief Title

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.

Study Type

Interventional

2. Study Status

Record Verification Date

January 2012

Overall Recruitment Status

Completed

Study Start Date

February 2007 (undefined)

Primary Completion Date

November 2007 (Actual)

Study Completion Date

December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Mast Therapeutics, Inc.

Collaborators

Synteract, Inc., Thywill Latam Solutions SRL, OCASA Soluciones Logísticas S.A., Worldwide Clinical Trials

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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 solution. ADVENTRX Pharmaceuticals, Inc. of San Diego, California, developed ANX-530 as a vinorelbine tartrate formulation to be used in clinical settings where Vinorelbine Tartrate Injection (NAVELBINE) is indicated. Nonclinical toxicology studies suggest either equivalent or less toxicity of ANX-530 compared to Reference Product. In particular, ANX-530 caused less vein toxicity in a rabbit vein irritation model, suggesting ANX-530 could potentially cause less venous irritation than NAVELBINE in a clinical setting. ADVENTRX is investigating whether ANX-530 could substitute for NAVELBINE in these settings.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer, Non-small Cell Lung Cancer, Non-Hodgkins Lymphoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

31 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Vinorelbine Tartrate

Other Intervention Name(s)

Exelbine (proposed), ANX-530

Intervention Description

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.

Primary Outcome Measure Information:

Title

Time to Reach Maximum Observed Plasma Concentration (Tmax)

Time Frame

0-144 hours post dose

Title

Maximum Observed Plasma Concentration (Cmax)

Time Frame

0-144 hours post-dose

Title

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

Description

Determined Using the Linear Trapezoidal Rule

Time Frame

0-144 hours post-dose

Title

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

Description

AUCinf = AUClast + (Clast/lamda z)

Time Frame

0-144 hours post-dose

Title

Percentage of AUCinf Based on Extrapolation (AUCextrap)

Time Frame

0-144 hours post-dose

Title

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

Description

Estimated via linear regression of the time versus log concentration

Time Frame

0-144 hours post-dose

Title

Observed Terminal Elimination Half-Life (t1/2)

Description

t1/2 = [ln(2)/λ z]

Time Frame

0-144 hours post-dose

Title

Time of Last Measurable Concentration (Tlast)

Time Frame

0-144 hours post-dose

Title

Last Quantifiable Drug Concentration (Clast)

Time Frame

0-144 hours post-dose

Title

Mean Residence Time (MRTinf)

Description

MRT = (AUMCinf)/(AUCinf)

Time Frame

0-144 hours post-dose

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials: