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Small Cell Lung CancerPhase 2NCT02995187

Study of Apatinib as Third-line and Later Therapy in Patients With Small Cell Lung Cancer (SCLC)

A Phase 2 study testing Apatinib Mesylate tablet in people with Small Cell Lung Cancer, run by Chinese Academy of Medical Sciences at 1 site in China.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

This is a Single-center, Open-label, Single-arm,Non-randomized exploratory clinical trial evaluating the efficacy and safety of Apatinib for third-line and later treatment of patients with small cell lung cancer. 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 Mesylate tablet
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteChina
Study dates
Dec 2016to Sep 2018
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

  • 18 years to 75 years;
  • Had a histologically or cytologically confirmed diagnosis of SCLC;
  • Had received at least 2 lines chemotherapy regimen and must include basis of the platinum regimen after which disease diagnosed;
  • Have not received VEGFR-TKI;
  • Had a life expectancy of at least 3 months;
  • Had an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2;
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  • Had a disease status that was measurable or evaluable as defined by Response Evaluation Criteria in Solid Tumors (RECIST, version1.1), larger than 10 mm in diameter by spiral CT scan;
  • Adequate hepatic, renal, heart, and hematologic functions (hemoglobin ≥90g/L, platelets ≥ 80×10^9/L, neutrophils ≥ 1.5×10^9/L, total bilirubin within 1.5×the upper limit of normal(ULN), and b) ALT and AST≤2.5×the ULN (If liver metastases, serum transaminase≤5×the ULN), serum creatine ≤ 1.25 x ULN, creatinine clearance rate > 45ml/min;
  • For women of child-bearing age, the pregnancy test results (serum or urine) within 7 days before enrolment must be negative. They will take appropriate methods for contraception during the study until the 8th week post the last administration of study drug. For men (previous surgical sterilization accepted), will take appropriate methods for contraception during the study until the 8th week post the last administration of study drug;
  • Signed and dated informed consent.Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure.

Who cannot join

  • Patients with non-small cell lung cancer;
  • Imaging (CT or MRI) results indicate that the existence of central tumors locally invading the large vessel could be detected, or apparent pulmonary cavity or necrotizing tumors;
  • Patients with clinical symptoms of brain metastases or meningeal metastasis;
  • Patients with poor-controlled arterial hypertension (systolic pressure ≥ 140 mmHg and/or diastolic pressure ≥ 90 mm Hg) despite standard medical management;
  • Suffered from grade II or above myocardial ischemia or myocardial infarction, uncontrolled arrhythmias (including QT interval male ≥ 450 ms, female ≥ 470 ms). Grade III-IV cardiac insufficiency according to New York Heart Association (NYHA) criteria or echocardiography check: left ventricular ejection fraction (LVEF)<50%;
  • Coagulant function abnormality (INR > 1.5 or prothrombin time (PT) > ULN + 4 seconds or APTT ULN > 1.5), with bleeding tendency or is treated with thrombolysis and anticoagulation;
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  • Patients whose routine urine tests indicate that urine protein ≥ ++ or verifies that the 24-h urine protein quantitation ≥ 1.0 g;
  • Patients who received major surgical operations or experienced severe traumatic injuries, bone fracture, or ulcers within 4 weeks before screening;
  • Patients who had obvious hemoptysis within 2 months before screening, or experienced daily hemoptysis with a volume more than half a tea spoon (2.5ml) or above; Patients who experienced bleeding symptoms of clinical significance , or with confirmed bleeding tendency such as hemorrhage of digestive tract, hemorrhagic gastric ulcer, baseline occult blood in stool ++ and above, or vasculitis, etc;
  • Patients who manifested arterial/venous thrombus events, e.g.cerebrovascular accident (including transient ischemic attack), deep venous thrombosis and pulmonary embolism, etc., within 12 months before screening;
  • Allergic to any ingredients of Apatinib;
  • Evidence of significant medical illness that in the investigator's judgment will substantially increase the risk associated with the subject's participation in and completion of the study.

Trial locations and contacts

1 site in 1 country.

Yutao Liu, M.D. contact

+8613911901165

13911901165@139.com

China1 site, 1 recruiting

  • Chinese Academy of Medical Sciences

    Beijing

    Yutao Liu, MD, 13911901165@139.com

    Recruiting

Other trials in China

About this study

Official title: A Non-randomized, Open-label, Prospective, Single-center Study of Apatinib Mesylate Tablet as Third-line and Later Therapy in Patients With Small Cell Cancer（SCLC）

This is a Single-center, Open-label, Single-arm,Non-randomized exploratory clinical trial evaluating the efficacy and safety of Apatinib for third-line and later treatment of patients with small cell lung cancer.

Read the detailed description

Although fist-line therapy with Cisplatin and etoposide(EP)or Carboplatin and etoposide(CE)and second-line therapy with topotecan has been given, patients with extensive small cell lung cancer(ED-SCLC) still relapse and 2-year survival is less than 10%. There is no standard treatment recommendation for this group of patients who failed to second-line therapy and had good performance status. Apatinib has been approved as a second-line treatment for advanced gastric cancer. Several phase III clinical studies of non small cell lung cancer, liver cancer, colorectal cancer and other tumors also showed apatinib has less toxic side effects and better patient tolerance. However, the clinical application of apatinib in small cell lung cancer is still lack of evidence-based medicine. And this clinical trial is designed to prospectively investigate the efficacy and safety of apatinib in recurrent SCLC patients in our center.

Being tested
Apatinib Mesylate tablet
Keywords
Apatinib, Third-line and Later Therapy, Small Cell Lung Cancer
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.

  • Apatinib Mesylate tabletDrug

    Also called Apatinib

    Apatinib 500 mg in tablet once daily

Study groups in NCT02995187
Study groupRoleWhat they receive
Apatinib Mesylate tabletExperimentalPatients received oral apatinib 500 mg in tablet once daily, a treatment cycle was defined as 28 days (4 weeks).
Receives: Drug: Apatinib Mesylate tablet

What is being measured

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

  1. Progression-free survival

    Measured: up to 3 years

Secondary outcomes (3)

  1. Overall survival

    Measured: up to 3 years

  2. Disease Control Rate

    Measured: up to 3 years

  3. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    Measured: up to 3 years

Timeline

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

  1. First posted16 Dec 2016 (estimated)
  2. Study startDec 2016
  3. Primary completionMay 2018 (estimated)
  4. Study completionSep 2018 (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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02995187
Sponsor's protocol ID
CH-L-061
Status last verified
Sep 2017
First submitted
14 Dec 2016
Last updated
7 Sep 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Liu Y, Hu X, Jiang J, Yang L, Zhou S, Liu P, Li J, Wang Y, Hao X, Shi Y. A Prospective Study of Apatinib in Patients with Extensive-Stage Small Cell Lung Cancer After Failure of Two or More Lines of Chemotherapy. Oncologist. 2020 May;25(5):e833-e842. doi: 10.1634/theoncologist.2019-0391. Epub 2020 Apr 6.

    PubMed 32250517

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Apatinib Mesylate tablet in people with Small Cell Lung Cancer, run by Chinese Academy of Medical Sciences 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 10 inclusion and 12 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 7 Sep 2017. 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?

Results are not available in the source record.

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

Contact Yutao Liu, M.D. (+8613911901165, 13911901165@139.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (time frame: up to 3 years). 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 NCT02995187, which also lists 1 linked publication.

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 7 Sep 2017.

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