Lung CancerPhase 4NCT04145570

A Single-Dose,ComparativeBioavailability Study ofTwo Formulations ofErlotinib150mgTabletsunderFastingConditions

A Phase 4 study testing Erlotinib HCl 150 mg and Tarceva® in people with Lung Cancer, run by Quadras Scientific Solutions.

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

Theobjectiveofthisstudyistoevaluatethecomparativebioavailabilitybetween: ErlotinibHCl150mgTablets(Novopharm Limited,Canada)and Tarceva® 150mgTablets(Hoffmann-LaRocheLimited,Canada) afterasingle-doseinhealthysubjectsunderfastingconditions. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Lung Cancer
What is being tested?: Erlotinib HCl 150 mg and Tarceva®
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: No sites listed yet
Study dates: 23 Oct 2008to 9 Nov 2008
Phase: Phase 4
Are there results?: None posted in the registry

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 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy, non-smoking, post-menopausal and/or surgically sterile female subjects
Healthy,non-smoking male subjects. Allsubjects willbe from 18 to 55 years ofage.

Who cannot join

Known history or presence of any clinically significant medicalcondition.
Known or suspected carcinoma.
Presence ofclinically significant gastrointestinal disease or history of malabsorption within the last year.
Presence of a medical condition requiring regular medication (prescription and/or over-the-counter) with systemic absorption.
Use of tobacco or nicotine-containing products within 6 months priorto drug administration.

About this study

Theobjectiveofthisstudyistoevaluatethecomparativebioavailabilitybetween:

ErlotinibHCl150mgTablets(Novopharm Limited,Canada)and
Tarceva® 150mgTablets(Hoffmann-LaRocheLimited,Canada) afterasingle-doseinhealthysubjectsunderfastingconditions.

Read the detailed description

This is a blinded,single-dose,randomized,two-period,two-sequence,two-treatment,cross over study, designed to evaluate the comparative bioavailability of two formulations of erlotinib HCl 150mg tablets administered to healthy male and female subjects under fasting conditions.

SubjectswererandomlyassignedtooneofthetwodosingsequencesABorBA underfasting conditions.

Conditions: Lung Cancer
Being tested: Erlotinib HCl 150 mg, Tarceva®
Medical subject headings: Lung Neoplasms

What participants receive

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

Erlotinib HCl 150 mgDrug
Concentrations of erlotinib were measured from the samples collected over a 72 hour interval after receiving either Erotinib generic or Tarceva original. Later, after 14 days, a crossover was took place with the same measures.
dosing in each period.
Tarceva®Drug
Tarceva® 150 mg

Study groups in NCT04145570
Study group	Role	What they receive
Erlotinib HCl 150 mg	Experimental	Crossover Receives: Drug: Erlotinib HCl 150 mg
Tarceva® 150 mg	Active comparator	Crossover Receives: Drug: Tarceva®

What is being measured

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

Bioequivalence (Biodisponibility)
Compared Bioequivalence
Measured: 72 hours

Timeline

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

23 Oct 20089 Nov 2008

First posted30 Oct 2019
Study start23 Oct 2008
Primary completion9 Nov 2008
Study completion9 Nov 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Lung 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 4
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Model description: Based on the log-transformed parameters, the following criteria were used to evaluate the bioequivalence between the test and reference products: * The 90% confidence interval of the relative mean AUCt of the test to reference products should be between80% and125%. * TherelativemeanCmaxofthetesttoreferenceproductsshouldbebetween80% and125%
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04145570
Sponsor's protocol ID: 2008-1877
Status last verified: Oct 2019
First submitted: 24 Oct 2019
Last updated: 30 Oct 2019
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 30 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-Dose,ComparativeBioavailability Study ofTwo Formulations ofErlotinib150mgTabletsunderFastingConditions
ClinicalTrials.gov ID: NCT04145570
Acronym / sponsor ID: 2008-1877
Conditions: Lung Cancer
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Quadras Scientific SolutionsUniversity, hospital or other
Study start: 23 Oct 2008 (actual)
Primary completion: 9 Nov 2008 (actual)
Study completion: 9 Nov 2008 (actual)
First posted: 30 Oct 2019 (actual)
Results: Not posted in the source record

Clinical summary

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

Theobjectiveofthisstudyistoevaluatethecomparativebioavailabilitybetween:

ErlotinibHCl150mgTablets(Novopharm Limited,Canada)and
Tarceva® 150mgTablets(Hoffmann-LaRocheLimited,Canada) afterasingle-doseinhealthysubjectsunderfastingconditions.

Detailed description

SubjectswererandomlyassignedtooneofthetwodosingsequencesABorBA underfasting conditions.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2
Model description: Based on the log-transformed parameters, the following criteria were used to evaluate the bioequivalence between the test and reference products: * The 90% confidence interval of the relative mean AUCt of the test to reference products should be between80% and125%. * TherelativemeanCmaxofthetesttoreferenceproductsshouldbebetween80% and125%

Arm	Type	Receives
Erlotinib HCl 150 mg	Experimental	Drug: Erlotinib HCl 150 mgCrossover
Tarceva® 150 mg	Active comparator	Drug: Tarceva®Crossover

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

Healthy, non-smoking, post-menopausal and/or surgically sterile female subjects
Healthy,non-smoking male subjects. Allsubjects willbe from 18 to 55 years ofage.

Key exclusion criteria (5 listed)

Known history or presence of any clinically significant medicalcondition.
Known or suspected carcinoma.
Presence ofclinically significant gastrointestinal disease or history of malabsorption within the last year.
Presence of a medical condition requiring regular medication (prescription and/or over-the-counter) with systemic absorption.
Use of tobacco or nicotine-containing products within 6 months priorto drug administration.

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
Erlotinib HCl 150 mgConcentrations of erlotinib were measured from the samples collected over a 72 hour interval after receiving either Erotinib generic or Tarceva original. Later, after 14 days, a crossover was took place with the same measures. dosing in each period.	Drug	Erlotinib HCl 150 mg
Tarceva®Tarceva® 150 mg	Drug	Tarceva® 150 mg

Primary outcome

Bioequivalence (Biodisponibility)
Time frame: 72 hours
Compared Bioequivalence

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2019.
Individual participant dataSharing planned: No

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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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Erlotinib HCl 150 mg and Tarceva® in people with Lung Cancer, run by Quadras Scientific Solutions.

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 2 inclusion and 5 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 30 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Bioequivalence (Biodisponibility) (time frame: 72 hours). 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 NCT04145570.

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 30 Oct 2019.