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Completed

NCT Number: NCT03059797

Study of Anlotinib in Patients With Small Cell Lung Cancer (ALTER1202)

To compare the effects and safety of Anlotinib with placebo in patients with small cell lung cancer(SCLC).

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histological documentation of small cell lung cancer
  • Advanced small cell lung cancer who had at least two chemotherapy regimens,at least one measurable lesion (by RECIST1.1)
  • 18-75 years,ECOG PS:0-2,Life expectancy of more than 3 months
  • Main organs function is normal
  • Women of childbearing potential should agree to use and utilize an adequate method of contraception (such as intrauterine device,contraceptive and condom) throughout treatment and for at least 6 months after study is stopped;the result of serum or urine pregnancy test should be negative within 7 days prior to study enrollment,and the patients required to be non-lactating;Man participants should agree to use and utilize an adequate method of contraception throughout treatment and for at least 6 months after study is stopped
  • Patients should participate in the study voluntarily and sign informed consent

Exclusion criteria

  • Patients who have been used anlotinib
  • Patients who have been used targeted drugs(such as sunitinib,bevacizumab,endostar),Immune targeted drugs
  • 4 weeks or less from the last cytotoxic therapy, radiation therapy or surgery
  • Patients whose primary lesion with active bleeding within 4 months
  • Carcinomatous meningitis
  • Patients who known to the central nervous system
  • Patients with factors that could affect oral medication (such as dysphagia,chronic diarrhea, intestinal obstruction etc.)
  • Patients with any severe and/or unable to control diseases,including:
  • Blood pressure unable to be controlled ideally(systolic pressure≥150 mmHg,diastolic pressure≥100 mmHg);
  • Patients with Grade 1 or higher myocardial ischemia, myocardial infarction or malignant arrhythmias(including QTc≥450ms(male),QTc≥470ms(female)) and patients with Grade 1 or higher congestive heart failure (NYHA Classification);
  • Patients with active or unable to control serious infections;
  • Patients with cirrhosis, decompensated liver disease, or active hepatitis;
  • Patients with poorly controlled diabetes (fasting blood glucose(FBG)>10mmol/L)
  • Urine protein ≥ ++,and 24-hour urinary protein excretion>1.0 g confirmed;
  • Patients with non-healing wounds or fractures
  • Patients with arterial or venous thromboembolic events occurred within 6 months, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism
  • Patients with drug abuse history and unable to get rid of or Patients with mental disorders
  • Imaging showed tumors have involved important blood vessels or by investigators determine likely during the follow-up study and cause fatal hemorrhage
  • History of immunodeficiency
  • Patients with concomitant diseases which could seriously endanger their own safety or could affect completion of the study according to investigators' judgment

Treatment and study plan

Anlotinib

Drug

Anlotinib Day 1 to day 14 followed by 7 days off treatment in a 21-day cycle

Placebo

Drug

Placebo Day 1 to day 14 followed by 7 days off treatment in a 21-day cycle

Primary outcomes

  1. Progress free survival (PFS)

    Time frame: From randomization,each 42 days up to PD or death(up to 24 months)

Secondary outcomes

  1. Overall Survival (OS)

    Time frame: From randomization until death (up to 24 months)

  2. Objective Response Rate (ORR)

    Time frame: each 42 days up to intolerance the toxicity or PD (up to 24 months)

  3. Disease Control Rate (DCR)

    Time frame: each 42 days up to intolerance the toxicity or PD (up to 24 months)

  4. Number of Participants with Adverse Events as a Measure of Safety and Tolerability

    Time frame: Until 30 day safety follow-up visit (up to 24 months)

Sponsors and collaborators

Lead sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Industry

Registry information

Official study title

A Randomized, Double-blind, Placebo-controlled, Multicenter Clinical Trial to Compare the Efficacy and Safety of Anlotinib Versus Placebo in Patients With Small Cell Lung Cancer(ALTER1202)

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Feb 23, 2017
Registry last updated
May 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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