Breast CancerPhase 1NCT00432562

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

A Phase 1 study testing Vinorelbine Tartrate in people with Breast Cancer and Non-small Cell Lung Cancer, run by Mast Therapeutics, Inc. at 5 sites in Argentina.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Breast Cancer, Non-small Cell Lung Cancer, Non-Hodgkins Lymphoma
What is being tested?: Vinorelbine Tartrate
How many people: 31 participants
Where: 5 sitesArgentina
Study dates: Feb 2007to Dec 2007
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Show all 12Show fewer

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.

Who cannot join

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).

Show all 9Show fewer

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.

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

Argentina5 sites

Clinical Investigative Site
Buenos Aires
Clinical Investigative Site
Mendoza
Clinical Investigative Site
Rosario
Clinical Investigative Site
San Miguel de Tucumán
Clinical Investigative Site
Santa Fe

Other trials in Argentina

About this study

Official title: A Bioequivalence Study of Vinorelbine Tartrate Injectable Emulsion (ANX-530) in Patients With Advanced Cancer.

Read the 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.

Conditions: Breast Cancer, Non-small Cell Lung Cancer, Non-Hodgkins Lymphoma
Being tested: Vinorelbine Tartrate
Medical subject headings: Breast Neoplasms, Carcinoma, Non-Small-Cell Lung, Lymphoma, Non-Hodgkin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Vinorelbine TartrateDrug
Also called Exelbine (proposed), ANX-530
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.

What is being measured

The primary outcome is the main question the study is designed to answer.

Time to Reach Maximum Observed Plasma Concentration (Tmax)
Measured: 0-144 hours post dose
Maximum Observed Plasma Concentration (Cmax)
Measured: 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
Measured: 0-144 hours post-dose
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf)
AUCinf = AUClast + (Clast/lamda z)
Measured: 0-144 hours post-dose
Percentage of AUCinf Based on Extrapolation (AUCextrap)
Measured: 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
Measured: 0-144 hours post-dose
Observed Terminal Elimination Half-Life (t1/2)
t1/2 = [ln(2)/λ z]
Measured: 0-144 hours post-dose
Time of Last Measurable Concentration (Tlast)
Measured: 0-144 hours post-dose
Last Quantifiable Drug Concentration (Clast)
Measured: 0-144 hours post-dose
Mean Residence Time (MRTinf)
MRT = (AUMCinf)/(AUCinf)
Measured: 0-144 hours post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2007Dec 2007

First posted8 Feb 2007 (estimated)
Study startFeb 2007
Primary completionNov 2007
Study completionDec 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Breast CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 31 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00432562
Sponsor's protocol ID: 530-01
Status last verified: Jan 2012
First submitted: 6 Feb 2007
Last updated: 23 Feb 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 23 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Bioequivalence Study of Vinorelbine Tartrate Injectable Emulsion (ANX-530) in Patients With Advanced Cancer.
ClinicalTrials.gov ID: NCT00432562
Acronym / sponsor ID: 530-01
Conditions: Breast Cancer, Non-small Cell Lung Cancer, Non-Hodgkins Lymphoma
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 31 participants (actual)
Lead sponsor: Mast Therapeutics, Inc.Industry (pharma, biotech, devices)
Collaborators: Synteract, Inc., Thywill Latam Solutions SRL, OCASA Soluciones Logísticas S.A., Worldwide Clinical Trials
Study start: Feb 2007
Primary completion: Nov 2007 (actual)
Study completion: Dec 2007 (actual)
First posted: 8 Feb 2007 (estimated)
Results: Posted 23 Feb 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

Age > 18 years.
Advanced cancer potentially sensitive to vinorelbine:
Breast cancer.
Stage 3 or 4 non-small cell lung cancer.
Non-Hodgkins lymphoma.

Key exclusion criteria (9 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Vinorelbine TartrateAlso: Exelbine (proposed), ANX-530Subjects 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.	Drug	–

Primary outcome

Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: 0-144 hours post dose
Maximum Observed Plasma Concentration (Cmax)
Time frame: 0-144 hours post-dose
Area Under the Plasma Concentratio-Time Curve From Time 0 to the Time of the Last Measurable Concentration (AUClast)
Time frame: 0-144 hours post-dose
Determined Using the Linear Trapezoidal Rule
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf)
Time frame: 0-144 hours post-dose
AUCinf = AUClast + (Clast/lamda z)
Percentage of AUCinf Based on Extrapolation (AUCextrap)
Time frame: 0-144 hours post-dose
Observed Elimination Rate Constant Associated With the Terminal Portion of the Curve (λ z)
Time frame: 0-144 hours post-dose
Estimated via linear regression of the time versus log concentration
Observed Terminal Elimination Half-Life (t1/2)
Time frame: 0-144 hours post-dose
t1/2 = [ln(2)/λ z]
Time of Last Measurable Concentration (Tlast)
Time frame: 0-144 hours post-dose
Last Quantifiable Drug Concentration (Clast)
Time frame: 0-144 hours post-dose
Mean Residence Time (MRTinf)
Time frame: 0-144 hours post-dose
MRT = (AUMCinf)/(AUCinf)

Results and safety

Results posted to the registry on 23 Feb 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ANX-530/Navelbine	16	13
Navelbine/ANX-530	15	15

Primary outcome: Time to Reach Maximum Observed Plasma Concentration (Tmax)

Time frame: 0-144 hours post dose. Mean (Standard Deviation). Unit: hours

Measure	ANX-530 n = 31	Navelbine n = 31
Value	0.35 (0.13)	0.34 (0.08)

Primary outcome: Maximum Observed Plasma Concentration (Cmax)

Time frame: 0-144 hours post-dose. Mean (Standard Deviation). Unit: ng/mL

Measure	ANX-530 n = 31	Navelbine n = 31
Value	227 (108)	223 (125)

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

Time frame: 0-144 hours post-dose. Mean (Standard Deviation). Unit: hr*ng/mL

Measure	ANX-530 n = 31	Navelbine n = 31
Value	757.8 (363.7)	716.1 (272.6)

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

Time frame: 0-144 hours post-dose. Mean (Standard Deviation). Unit: hr*ng/mL

Measure	ANX-530 n = 31	Navelbine n = 30
Value	810.1 (400.9)	718.5 (223.5)

Adverse events

Time frame: AEs and their treatment were documented from the time of the first dose of study medication until 30 days after the last dose. Mild, moderate and severe AEs not related to study treatment were followed for approx 30 days after the last study drug dose.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ANX-530/Navelbine	5 of 16 (31.3%)	21 of 31 (67.7%)	Not reported
Navelbine/ANX-530	1 of 15 (6.7%)	22 of 31 (71%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Not yet recruitingObservational study
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RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Lino Arboit, M.D. principal investigator

Fundación Centro Oncológico de Integración Regional - COIR.

Gerardo F Arroyo, M.D. principal investigator

Hospital Privado De Santa Clara De Asis

Cesar R Blajman, M.D. principal investigator

Isis Clínica Especializada

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Vinorelbine Tartrate in people with Breast Cancer and Non-small Cell Lung Cancer, run by Mast Therapeutics, Inc. at 5 sites in Argentina.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Feb 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to Reach Maximum Observed Plasma Concentration (Tmax) (time frame: 0-144 hours post dose). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00432562.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2012.