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Small-cell Lung CancerPhase 2MK 01NCT03547804

A Prospective, Single-center, One-arm Clinical Study of Apatinib Combined With Chemotherapy for Pretreated Patients With Advanced Small Cell Lung Cancer

A Phase 2 study testing Apatinib and chemotherapy in people with Small-cell Lung Cancer, run by The First Hospital of Jilin University at 1 site in China.

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

At present, with the increasing intensities of the tobacco industry and air pollution in China, the incidence and mortality of lung cancer have become the most important issue that threatens human health.Over the past two decades, the treatment of SCLC still stays in the mode of treatment based on radiotherapy and… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Small-cell Lung Cancer
What is being tested?
Apatinib and chemotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
1 siteChina
Study dates
31 May 2018to 1 Sep 2020
Phase
Phase 2
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1, male or female patients: 18-75 years old;
  • 2. ECOG performance status score: 0~2 points;
  • 3, pathological examination specifically for small cell lung cancer
  • 4. Expected survival period ≥12 weeks;
  • 5. The normal function of major organs, that is, the relevant inspection indicators within the first 14 days of randomness, meet the following requirements:
  • 1) Blood tests:
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  • Hemoglobin ≥ 90 g/L (without transfusion in 14 days); b) Neutrophil count ≥ 1.5×109/L; c) Platelet count ≥ 100×109/L; 2) Biochemical check:
  • total bilirubin ≤ 1.5 x ULN (upper limit of normal value);
  • serum alanine aminotransferase (ALT) or serum aspartate aminotransferase (AST) ≤ 2.5 × ULN; if liver metastases, ALT or AST ≤ 5 × ULN;
  • Serum creatinine < 1.5 times the upper limit of normal; Endogenous creatinine clearance ≥ 50 ml/min (Cockcroft-Gault formula); 3) Assessment of cardiac Doppler ultrasound: Left ventricular ejection fraction (LVEF) ≥ 50%.
  • 6. Women of childbearing age must have a pregnancy test (serum or urine) within 7 days prior to enrollment, and the result is negative, and they are willing to use appropriate methods of contraception during the trial and within 8 weeks of the last administration of the test drug. For males, consent must be given for contraception or surgical sterilization within 8 weeks of the test period and the last administration of the test drug;
  • 7. Subjects have completely healed after surgery and no bleeding tendency;
  • 8. Good compliance, family members agree to follow the survival follow-up;
  • 9. Sign the informed consent form.

Who cannot join

  • in the past or at the same time suffering from other malignant tumors,
  • participated in other drug clinical trials within four weeks;
  • has a variety of factors that affect oral medication (such as inability to swallow, chronic diarrhea, and intestinal obstruction);
  • 4. There is a history of bleeding, and any serious grading within 4 weeks prior to screening has reached 3 degrees or more in CTCAE 4.0;
  • 5. Pre-screening patients with symptomatic central nervous system metastasis or history of central nervous system metastasis;
  • 6, patients who undergo chest radiotherapy during the first-line treatment can be enrolled in the group;
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  • 7. People with high blood pressure who cannot be well controlled by single antihypertensive drugs (systolic blood pressure > 140 mmHg, diastolic blood pressure> 90 mmHg); patients with a history of unstable angina; newly diagnosed angina in the first 3 months before screening or myocardial infarction within 6 months prior to screening; arrhythmia (including QTcF: male ≥450 ms , ≥ 470 ms for females) long-term use of antiarrhythmic drugs and New York Heart Association grade ≥ grade II cardiac insufficiency;
  • 8, urine prompts urinary protein ≥ ++ and confirmed 24-hour urinary protein quantification> 1.0 g;
  • 9, combined with anastomotic leakage, duodenal stump fistula, pancreatic fistula or anastomotic stenosis and other serious postoperative complications;
  • 10. Long-term unhealed wounds or incompletely-healed fractures;
  • 11. Imaging shows that the tumor has invaded an important blood vessel or the investigator judged that the patient's tumor had a high risk of invading vital blood vessels and causing fatal bleeding during treatment;
  • 12, abnormal coagulation, bleeding tendency (14 days before randomization must meet: in the absence of resistance In the case of coagulants, the INR is within the normal range; Patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin, or the like; International normalized ratio (INR) ≤ 1.5 for prothrombin time Under the premise that small doses of warfarin (1 mg orally, once daily) or low dose aspirin (with daily dose not exceeding 100 mg) are allowed for prophylactic purposes;
  • 13. Incidence of arteriovenous/venous thromboembolism within the first year of screening, such as cerebrovascular accident (including transient ischemic attack), deep venous thrombosis (except for venous thrombosis due to venous catheterization in previous chemotherapy) ) and pulmonary embolism;
  • 14. For female subjects: Surgical sterilization, postmenopausal patients, or agree to use a medically approved contraceptive measure during study treatment and within 6 months of the end of the study treatment period; prior to study enrollment Serum or urine pregnancy tests must be negative within 7 days and must be non-lactating. Male subjects: Should be surgically sterilized, or agree to use a medically-accepted contraceptive treatment during study treatment and within 6 months of the end of the study treatment period;
  • 15. In the past, there was abnormal thyroid function. Even in the case of drug therapy, thyroid function could not be maintained within the normal range.
  • 16. Those who have a history of abuse of psychotropic substances and are unable to get rid of or have mental disorders;
  • 17. Has a history of immunodeficiency, or has other acquired, congenital immunodeficiency disorders, or has a history of organ transplantation.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The First Hospital Of Jilin University

    Changchun, Jilin, 130000

Other trials in China

About this study

At present, with the increasing intensities of the tobacco industry and air pollution in China, the incidence and mortality of lung cancer have become the most important issue that threatens human health.Over the past two decades, the treatment of SCLC still stays in the mode of treatment based on radiotherapy and chemotherapy.

This is a prospective, single-center, one-arm clinical study designed to evaluate the efficacy and safety of apatinib plus chemotherapy for second-line and above treatment of advanced SCLC.

30 patients will receive apatinib 500mg qd orally, if the patient has a grade 3/4 adverse reaction during apatinib treatment, it can be reduced to apatinib 250mg qd orally.The dose was later reduced from 500 mg to 250 mg per day based on a recommendation of the principal investigator to reduce the adverse events. Chemotherapeutic agents are limited to irinotecan or docetaxel alone.The primary outcome endpoint was progression-free survival

Being tested
Apatinib, chemotherapy
Medical subject headings
Small Cell Lung Carcinoma

What participants receive

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

  • ApatinibDrug

    500 mg qd/250mg

  • chemotherapyDrug

    Chemotherapeutic agents are limited to irinotecan or docetaxel alone.

Study groups in NCT03547804
Study groupRoleWhat they receive
experimental armExperimentalapatinib 500 mg qd;The dose was later reduced from 500 mg to 250 mg per day based on a recommendation of the principal investigator to reduce the adverse events.Chemotherapeutic agents are limited to irinotecan or docetaxel alone.
Receives: Drug: Apatinib; Drug: chemotherapy

What is being measured

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

  1. PFS

    Progression-free survival

    Measured: 1 year

Secondary outcomes (4)

  1. OS

    Overall survival

    Measured: 5 years

  2. AEs

    Adverse events

    Measured: 1 year

  3. DCR

    Disease Control Rate

    Measured: 1 year

  4. ORR

    Objective Response Rate

    Measured: 1 year

Timeline

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

  1. First posted6 Jun 2018
  2. Study start31 May 2018
  3. Primary completion25 Oct 2019
  4. Study completion1 Sep 2020

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03547804
Sponsor's protocol ID
K2018012
Acronym
MK 01
Status last verified
Sep 2020
First submitted
24 May 2018
Last updated
1 Dec 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Li J, Qin S, Xu J, Xiong J, Wu C, Bai Y, Liu W, Tong J, Liu Y, Xu R, Wang Z, Wang Q, Ouyang X, Yang Y, Ba Y, Liang J, Lin X, Luo D, Zheng R, Wang X, Sun G, Wang L, Zheng L, Guo H, Wu J, Xu N, Yang J, Zhang H, Cheng Y, Wang N, Chen L, Fan Z, Sun P, Yu H. Randomized, Double-Blind, Placebo-Controlled Phase III Trial of Apatinib in Patients With Chemotherapy-Refractory Advanced or Metastatic Adenocarcinoma of the Stomach or Gastroesophageal Junction. J Clin Oncol. 2016 May 1;34(13):1448-54. doi: 10.1200/JCO.2015.63.5995. Epub 2016 Feb 16.

    PubMed 26884585

  • Huang L, Wei Y, Shen S, Shi Q, Bai J, Li J, Qin S, Yu H, Chen F. Therapeutic effect of apatinib on overall survival is mediated by prolonged progression-free survival in advanced gastric cancer patients. Oncotarget. 2017 Apr 25;8(17):29346-29354. doi: 10.18632/oncotarget.12897.

    PubMed 27793017

  • Kim KL, Suh W. Apatinib, an Inhibitor of Vascular Endothelial Growth Factor Receptor 2, Suppresses Pathologic Ocular Neovascularization in Mice. Invest Ophthalmol Vis Sci. 2017 Jul 1;58(9):3592-3599. doi: 10.1167/iovs.17-21416.

    PubMed 28715845

  • Li F, Zhu T, Cao B, Wang J, Liang L. Apatinib enhances antitumour activity of EGFR-TKIs in non-small cell lung cancer with EGFR-TKI resistance. Eur J Cancer. 2017 Oct;84:184-192. doi: 10.1016/j.ejca.2017.07.037. Epub 2017 Aug 17.

    PubMed 28822888

  • Wu F, Zhang S, Gao G, Zhao J, Ren S, Zhou C. Successful treatment using apatinib with or without docetaxel in heavily pretreated advanced non-squamous non-small cell lung cancer: A case report and literature review. Cancer Biol Ther. 2018 Mar 4;19(3):141-144. doi: 10.1080/15384047.2017.1414757. Epub 2018 Jan 15.

    PubMed 29261000

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Apatinib and chemotherapy in people with Small-cell Lung Cancer, run by The First Hospital of Jilin University at 1 site in China.

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 14 inclusion and 17 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 1 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

PFS (time frame: 1 year). 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 NCT03547804, which also lists 5 linked publications.

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 1 Dec 2020.

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