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Non-small Cell Lung CancerPhase 4NCT03264794

the Clinical Trial of Gefitinib(Non - Small Cell Lung Cancer)

A Phase 4 study testing Gefitinib Tab （CTTQ），First medication；Gefitinib Tab （CTTQ），From the 8th day of trial, Gefitinib tablets (Yi Ruisha），First medication and Gefitinib Tab 250 MG（CTTQ），From the 8th day of trial. in people with Non-small Cell Lung Cancer, run by Jiangsu Famous Medical Technology Co., Ltd..

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

1. Gefitinib CTTQ production gefitinib and erlotinib sheet AstraZeneca imatinib sheet (trade name: Iressa ®) comparison, human pharmacokinetics and relative bioavailability of comparative studies which examine people in vivo pharmacokinetic behavior, provide the basis for clinical use. 2. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-small Cell Lung Cancer
What is being tested?
Gefitinib Tab （CTTQ），First medication；Gefitinib Tab （CTTQ），From the 8th day of trial, Gefitinib tablets (Yi Ruisha），First medication and Gefitinib Tab 250 MG（CTTQ），From the 8th day of trial.
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
No sites listed yet
Study dates
Aug 2017to Jun 2022
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients volunteered to participate in this study, signed informed consent;
  • ≥18 years old; ECOG PS score: 0 ~ 1; expected survival period of more than 3 months;
  • patients with locally advanced or metastatic non-small cell lung cancer diagnosed by histology or cytology, who can not receive radical surgery or radiotherapy; patients with measurable lesions(according to RECIST criteria);
  • Detection of EGFR-positive exon 19 deletion or exon 21 (L858R) mutation was performed by providing a detectable specimen (tissue or cancerous pleural effusion) prior to enrollment;
  • The main organ function within 7 days before treatment, meet the following criteria:
  • blood routine examination criteria (14 days without blood transfusion): A) hemoglobin≥ 90g / L; B) neutrophil absolute ≥ 1.5 × 109 / L; C) platelet ≥80 × 109 / L (2) biochemical tests to meet the following criteria: A) total bilirubin ≤ 1.5 times the upper limit of normal (ULN); B) alanine aminotransferase and aspartate aminotransferase AST ≤ 2.5ULN, such as liver metastasis, ALT and AST ≤ 5ULN; C) serum creatinine ≤ 1.5ULN or creatinine clearance ≥ 60ml / min; (3) Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) ≥ normal low (50%).
  • 6.Women of childbearing age should agree that contraceptive measures (such as intrauterine devices, birth control pills or condoms) must be used within the study period and within 6 months after the end of the study; serum or urine pregnancy test is negative within 7 days prior to enrollment, And must be non-lactating patients; men should agree to patients who have contraceptive use during the study period and six months after the end of the study period.

Who cannot join

  • patients who have previously used EGFR-TKI drugs;
  • small cell lung cancer (including small cell carcinoma and non-small cell carcinoma mixed lung cancer);
  • central type, with empty lung squamous cell carcinoma, or with non-small cell lung cancer with hemoptysis (> 50 ml / day) 4.5 years or at the same time with other malignancies, cured cervical carcinoma in situ, non-melanoma skin cancer and superficial bladder tumor except [Ta (non-invasive tumor), Tis (carcinoma in situ ) And T1 (tumor infiltrating basement membrane)];
  • 5.Whole-body antitumor therapy was planned within 4 weeks prior to randomization or during the course of this study, including cytotoxic therapy, signal transduction inhibitors, immunotherapy (or use of mitogen at 6 weeks prior to administration of the test drug) C); 6.patients with symptomatic or unstable brain metastases; 7.patients with any severe and / or uncontrolled disease, including: A) cirrhosis, acute or active hepatitis; B) history of immunodeficiency, including HIV-positive or other acquired, congenital immunodeficiency disease, or history of organ transplantation; C) patients with seizures and who need treatment; 8.active or uncontrollable serious infection (≥CTC AE Level 2 infection); 9.with a history of mental illness and can not quit or have mental disorders; 10.participated in other anti-tumor drug clinical trials within four weeks; 11.According to the judge's judgment, there is an impact on the absorption of oral drugs or serious harm to the safety of patients is not suitable for participation in the study of the situation.

About this study

Official title: Evaluation of the Efficacy of Domestic Gefitinib Tablets in the Treatment of Locally Advanced or Metastatic Non-small Cell Lung Cancer Patients Using a Multicenter, Randomized, Positive Drug Gefitinib Pharmacodynamics and Pharmacodynamics

  1. Gefitinib CTTQ production gefitinib and erlotinib sheet AstraZeneca imatinib sheet (trade name: Iressa ®) comparison, human pharmacokinetics and relative bioavailability of comparative studies which examine people in vivo pharmacokinetic behavior, provide the basis for clinical use.
  2. Evaluation CTTQ gefitinib imatinib sheet production efficacy and safety of Chinese patients with locally advanced or metastatic non-small cell lung cancer.
Being tested
Gefitinib Tab （CTTQ），First medication；Gefitinib Tab （CTTQ），From the 8th day of trial, Gefitinib tablets (Yi Ruisha），First medication, Gefitinib Tab 250 MG（CTTQ），From the 8th day of trial.
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

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

  • Gefitinib Tab （CTTQ），First medication；Gefitinib Tab （CTTQ），From the 8th day of trialDrug

    Gefitinib Tab （CTTQ），First medication,250mg；

  • Gefitinib tablets (Yi Ruisha），First medicationDrug

    Gefitinib tablets (Yi Ruisha），First medication,250mg；

  • Gefitinib Tab 250 MG（CTTQ），From the 8th day of trial.Drug

    From the 8th day of the experiment, two groups of subjects were treated with Gefitinib（CTTQ）

Study groups in NCT03264794
Study groupRoleWhat they receive
trial groupExperimentalGefitinib tablets (CTTQ），First medication.From the 8th day of the experiment, treated with Gefitinib Tab（CTTQ）
Receives: Drug: Gefitinib Tab （CTTQ），First medication；Gefitinib Tab （CTTQ），From the 8th day of trial; Drug: Gefitinib Tab 250 MG（CTTQ），From the 8th day of trial.
control groupActive comparatorGefitinib tablets (Yi Ruisha），First medication.From the 8th day of the experiment, treated with Gefitinib Tab（CTTQ）
Receives: Drug: Gefitinib tablets (Yi Ruisha），First medication; Drug: Gefitinib Tab 250 MG（CTTQ），From the 8th day of trial.

What is being measured

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

  1. Gefitinib plasma concentration

    After the use of gefitinib to reach the highest plasma concentration

    Measured: 0hour before administration and 1, 2, 3, 4, 5, 6, 7, 8,9,13,24,48,72,120,168 16 hour time points after administration

  2. Tmax time

    Taking the time required for the concentration of gefitinib to reach the peak

    Measured: 0hour before administration and 1, 2, 3, 4, 5, 6, 7, 8,9,13,24,48,72,120,168 16 hour time points after administration

  3. AUC0-t

    The area between the axis of the coordinate and the time drug concentration curve

    Measured: 0hour before administration and 1, 2, 3, 4, 5, 6, 7, 8,9,13,24,48,72,120,168 16 hour time points after administration

  4. t 1/2

    The time required for gefitinib to decrease by half the highest concentration in plasma

    Measured: 0hour before administration and 1, 2, 3, 4, 5, 6, 7, 8,9,13,24,48,72,120,168 16 hour time points after administration

  5. F

    Gefitinib absorbs the relative amount of blood into the cycle

    Measured: 0hour before administration and 1, 2, 3, 4, 5, 6, 7, 8,9,13,24,48,72,120,168 16 hour time points after administration

Timeline

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

  1. First posted29 Aug 2017
  2. Study startAug 2017 (estimated)
  3. Primary completionDec 2021 (estimated)
  4. Study completionJun 2022 (estimated)

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03264794
Sponsor's protocol ID
CTTQ-20161017
Status last verified
Jan 2017
First submitted
3 Jul 2017
Last updated
29 Aug 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Gefitinib Tab （CTTQ），First medication；Gefitinib Tab （CTTQ），From the 8th day of trial, Gefitinib tablets (Yi Ruisha），First medication and Gefitinib Tab 250 MG（CTTQ），From the 8th day of trial. in people with Non-small Cell Lung Cancer, run by Jiangsu Famous Medical Technology Co., Ltd..

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 7 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 29 Aug 2017. 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?

Results are not available in the source record.

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?

Gefitinib plasma concentration (time frame: 0hour before administration and 1, 2, 3, 4, 5, 6, 7, 8,9,13,24,48,72,120,168 16 hour time points after administration). The study lists 5 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 NCT03264794.

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 29 Aug 2017.

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