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Study of Anlotinib Hydrochloride Capsule in Subjects With Small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT04073550
Recruitment Status : Not yet recruiting
First Posted : August 29, 2019
Last Update Posted : August 29, 2019
Sponsor:
Information provided by (Responsible Party):
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Brief Summary:
Anlotinib hydrochloride is a multi-targeted receptor tyrosine kinase inhibitor that targets angiogenesis-related kinases such as VEGFR1/2/3, FGFR1/2/3, and other tumor-associated kinases involved in cell proliferation such as PDGFRα/β, c-Kit, and Ret have significant inhibitory activities.

Condition or disease Intervention/treatment Phase
Small Cell Lung Cancer Drug: Anlotinib Drug: Placebos Drug: Topotecan Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 184 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Multicenter, Phase Ⅲ Study of Anlotinib Hydrochloride Capsule Combined With Topotecan Versus Placebo Combined With Topotecan in Subjects With Small Cell Lung Cancer
Estimated Study Start Date : October 31, 2019
Estimated Primary Completion Date : July 31, 2021
Estimated Study Completion Date : July 31, 2022


Arm Intervention/treatment
Experimental: Experimental group
Anlotinib hydrochloride capsules given orally in fasting conditions , once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21) and topotecan 1.5mg/m2 IV d1-5.
Drug: Anlotinib
A multi-target receptor tyrosine kinase inhibitor.

Drug: Topotecan
A topoisomerase I inhibitor.

Placebo Comparator: Placebo group
Anlotinib hydrochloride placebo given orally in fasting conditions , once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21) and topotecan 1.5mg/m2 IV d1-5.
Drug: Placebos
Anlotinib blank analog capsule.

Drug: Topotecan
A topoisomerase I inhibitor.




Primary Outcome Measures :
  1. Progression Free Survival (PFS) evaluated by IRC [ Time Frame: up to 24 months ]
    PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause; IRC defined as Independent Review Committee.


Secondary Outcome Measures :
  1. Progression Free Survival (PFS) evaluated by investigator [ Time Frame: up to 24 months ]
    PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause.

  2. Overall survival (OS) [ Time Frame: up to 24 months ]
    OS defined as the time from randomization to death from any cause. Participants who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive.

  3. Overall Response Rate (ORR) [ Time Frame: up to 24 months ]
    Percentage of Participants Achieving Complete Response (CR) and Partial Response (PR).

  4. Disease Control Rate (DCR) [ Time Frame: up to 24 months ]
    Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD).

  5. Duration of Overall Response (DOR) [ Time Frame: up to 24 months ]
    The time when the patient first achieved complete or partial remission to disease progression.

  6. PFS rate at month 6 [ Time Frame: up to 6 months ]
    The percentage of PFS at month 6.

  7. OS rate at month 6 [ Time Frame: up to 6 months ]
    The percentage of OS at month 6.

  8. OS rate at month 12 [ Time Frame: up to 12 months ]
    The percentage of OS at month 12.

  9. The efficacy of intracranial lesions [ Time Frame: up to 24 months ]
    To evaluate the efficacy of of intracranial lesions.

  10. Adverse Event (AE) [ Time Frame: up to 24 months ]
    Safety data

  11. Serious Adverse Event (SAE) [ Time Frame: up to 24 months ]
    Safety data

  12. Abnormal laboratory test index [ Time Frame: up to 24 months ]
    Safety data



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Small cell lung cancer patients.
  2. The clinical stage at baseline is extensive.
  3. A measurable lesion.
  4. Disease progression.
  5. ≥ 18 years old; Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; Life expectancy ≥ 3 months.
  6. Adequate laboratory indicators.
  7. No pregnant or breastfeeding women, and a negative pregnancy test.
  8. Understood and signed an informed consent form.

Exclusion Criteria:

  1. Has used topotecan and anlotinib hydrochloride capsules.
  2. Has used other anti-angiogenic drugs and immunologically targeted drugs.
  3. Has other malignant tumors within 5 years.
  4. Symptomatic brain metastasis.
  5. Has a variety of factors affecting oral medications.
  6. Uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage.
  7. Spinal cord compression.
  8. Has received radiotherapy, chemotherapy, surgery less than 4 weeks before randomization.
  9. Adverse events caused by previous treatment did not recover to grade 1.
  10. Has received major surgical treatment within 4 weeks before randomization.
  11. Arteriovenous thrombosis occurred within 6 months.
  12. Has drug abuse history that unable to abstain from or mental disorders.
  13. Has severe or uncontrolled disease.
  14. Participated in other clinical trials within 4 weeks.
  15. Tumor invades the large blood vessels.
  16. Daily hemoptysis ≥2.5 mL within 1 month before the first dose.
  17. According to the investigators' judgement.

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): NCT04073550


Contacts
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Contact: YuanKai Shi, Master 010-87788293 syuankaipumc@126.com

Locations
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China, Beijing
Beijing Cancer Hospital Not yet recruiting
Beijing, Beijing, China, 100083
Contact: Ziping Wang, Doctor    010-88196456    wangzp2007@126.com   
Principal Investigator: Ziping Wang, Doctor         
Cancer Hospital Chinese Academy of Medical Sciences Not yet recruiting
Beijing, Beijing, China, 100083
Contact: Yuankai Shi, Master    010-87788293    syuankaipumc@126.com   
Principal Investigator: Yuankai Shi, Master         
Sponsors and Collaborators
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

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Responsible Party: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
ClinicalTrials.gov Identifier: NCT04073550     History of Changes
Other Study ID Numbers: ALTN-12-III-01
First Posted: August 29, 2019    Key Record Dates
Last Update Posted: August 29, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: 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
Topotecan
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents