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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03059797
Recruitment Status : Completed
First Posted : February 23, 2017
Last Update Posted : May 16, 2019
Sponsor:
Information provided by (Responsible Party):
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

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

Condition or disease Intervention/treatment Phase
Small Cell Lung Cancer Drug: Anlotinib Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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)
Actual Study Start Date : March 27, 2017
Actual Primary Completion Date : June 30, 2018
Actual Study Completion Date : May 6, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Anlotinib
Anlotinib Day 1 to day 14 followed by 7 days off treatment in a 21-day cycle
 Drug: Anlotinib
Anlotinib Day 1 to day 14 followed by 7 days off treatment in a 21-day cycle
Placebo Comparator: Placebo
Placebo Day 1 to day 14 followed by 7 days off treatment in a 21-day cycle
 Drug: Placebo
Placebo Day 1 to day 14 followed by 7 days off treatment in a 21-day cycle


Outcome Measures
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Primary Outcome Measures :
  1. Progress free survival (PFS) [ Time Frame: From randomization，each 42 days up to PD or death(up to 24 months) ]

Secondary Outcome Measures :
  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) ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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：

    1. Blood pressure unable to be controlled ideally(systolic pressure≥150 mmHg，diastolic pressure≥100 mmHg);
    2. 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);
    3. Patients with active or unable to control serious infections;
    4. Patients with cirrhosis, decompensated liver disease, or active hepatitis;
    5. Patients with poorly controlled diabetes (fasting blood glucose(FBG)>10mmol/L)
    6. 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03059797


Locations
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China, Beijing
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing, China, 100021
The 307th Hospital of Chinese People's Liberation Army
Beijing, Beijing, China, 100071
China, Guangdong
Guangdong General Hospital
Guangzhou, Guangdong, China, 510080
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China, 510120
China, Heilongjiang
Harbin medical university affiliated tumor hospital
Harbin, Heilongjiang, China, 150081
China, Henan
Henan Cancer Hospital
Zhengzhou, Henan, China, 450008
China, Hunan
Hunan Cancer Hospital
Changsha, Hunan, China, 410006
China, Jilin
Jilin Cancer Hospital
Changchun, Jilin, China, 130012
China, Liaoning
Liaoning Cancer Hospital
Shenyang, Liaoning, China, 110042
China, Shandong
Linyi Cancer Hospital
Linyi, Shandong, China, 276000
China, Shanghai
Shanghai Chest Hospital
Shanghai, Shanghai, China, 200030
China, Tianjin
Tianjin Medical University Cancer Hospital
Tianjin, Tianjin, China, 300060
Sponsors and Collaborators
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
ClinicalTrials.gov Identifier: NCT03059797    
Other Study ID Numbers: ALTN-12-II
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms