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

NCT02995187 | Unknown Phase 2 DMC

• 1 other identifier: CH-L-061
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Small Cell Lung Cancer

Keywords

Apatinib; Third-line and Later Therapy; Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  up to 3 years

Secondary Outcomes (3)

• Overall survival

  up to 3 years

• Disease Control Rate

  up to 3 years

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

  up to 3 years

Other Outcomes (1)

• tumor phosphorylated VEGFR2 (p-VEGFR2) expressions

  baseline

Study Arms (1)

Apatinib Mesylate tablet

EXPERIMENTAL

Patients received oral apatinib 500 mg in tablet once daily, a treatment cycle was defined as 28 days (4 weeks).

Drug: Apatinib Mesylate tablet

Interventions

Apatinib Mesylate tablet DRUG

Apatinib 500 mg in tablet once daily

Also known as: Apatinib

Apatinib Mesylate tablet

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Chinese Academy of Medical Sciences: lead

Study Sites (1)

Chinese Academy of Medical Sciences

Beijing, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 32250517 DERIVED

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

apatinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Yutao Liu, M.D.

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yutao Liu, M.D.

CONTACT

+8613911901165; 13911901165@139.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Physician

Study Record Dates

• First Submitted: December 14, 2016
• First Posted: December 16, 2016
• Study Start: December 1, 2016
• Primary Completion: May 1, 2018
• Study Completion: September 1, 2018
• Last Updated: September 7, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)