Study of Anlotinib in Patients With Advanced Medullary Thyroid Carcinoma

July 24, 2023 updated by: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

A Real World Study of Anlotinib for Patients With Advanced Medullary Thyroid Carcinoma

This is a real world study aiming to observe the efficacy and safety of Anlotinib capsules in patients with advanced medullary thyroid carcinoma, and to summarize the treatment experience in a broad population of patients.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

360

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China, 230031
        • Not yet recruiting
        • Anhui Provincial Cancer Hospital
        • Contact:
          • Shengying Wang, PhD
          • Phone Number: +86 18963790387
    • Beijing
      • Beijing, Beijing, China, 100005
        • Recruiting
        • Beijing Tongren Hospital Affiliated to Capital Medical University
        • Contact:
          • Xiaohong Chen
          • Phone Number: +86 13911071002
    • Gansu
      • Lanzhou, Gansu, China, 730050
        • Recruiting
        • Gansu Cancer Hospital
        • Contact:
          • Jun Wang, PhD
          • Phone Number: +86 13893338170
    • Guangxi
      • Nanning, Guangxi, China, 530021
        • Not yet recruiting
        • Guangxi Zhuang Autonomous Region Cancer Hospital (Affiliated Cancer Hospital of Guangxi Medical University)
        • Contact:
    • Hebei
      • Shijiazhuang, Hebei, China, 050051
        • Recruiting
        • The First Affiliated Hospital of Hebei North University
        • Contact:
          • Xiaoling Shang, PhD
          • Phone Number: +86 15530396553
      • Tianjin, Hebei, China, 300181
        • Recruiting
        • Tianjin Cancer Hospital
        • Contact:
    • Henan
      • Zhengzhou, Henan, China, 450003
        • Recruiting
        • Henan Cancer Hospital
        • Contact:
      • Zhengzhou, Henan, China, 450052
        • Recruiting
        • The First Affiliated Hospital of Zhengzhou University
        • Contact:
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Recruiting
        • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • Contact:
      • Wuhan, Hubei, China, 430079
        • Recruiting
        • Hubei Cancer Hospital
        • Contact:
    • Hunan
      • Changsha, Hunan, China, 410031
        • Not yet recruiting
        • Hunan Cancer Hospital
        • Contact:
    • Jiangsu
      • Nanjing, Jiangsu, China, 210008
        • Recruiting
        • Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University
        • Contact:
      • Yangzhou, Jiangsu, China, 225003
        • Recruiting
        • Jiangsu North People's Hospital
        • Contact:
    • Liaoning
      • Shenyang, Liaoning, China, 110801
        • Recruiting
        • Liaoning Cancer Hospital and Institute
        • Contact:
    • Shanxi
      • Xi'an, Shanxi, China, 710061
        • Recruiting
        • The First Affiliated Hospital of Xi'An JiaoTong University
        • Contact:
      • Xi'an, Shanxi, China, 710065
        • Not yet recruiting
        • Shanxi Provincial Tumor Hospital
        • Contact:
          • Yuan An, PhD
          • Phone Number: +86 15389233663
    • Tianjin
      • Tianjin, Tianjin, China, 300122
        • Recruiting
        • Tianjin People's Hospital
        • Contact:
    • Yunnan
      • Kunming, Yunnan, China, 650032
        • Recruiting
        • The First Affiliated Hospital of Kunming Medical University
        • Contact:
    • Zhejiang
      • Hangzhou, Zhejiang, China, 314408
        • Recruiting
        • Zhejiang Provincial People's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients voluntarily joined the study, signed the informed consent, and had good compliance;
  • Patients ≥18 years of age (at the time of signing the informed consent); Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score: 0-2; Expected survival of more than 3 months;
  • Patients were pathologically confirmed as inoperable locally advanced or metastatic medullary thyroid carcinoma (MTC), possessing imaging or clinical evidence of disease progression within the first 14 months of enrollment;
  • Having at least one measurable lesion (assessed by Response Evaluation Criteria In Solid Tumors (RECIST) 1.1);

  • Major organ functions meet the following criteria within 7 days prior to the treatment:

    1. Blood routine examination shall meet the following standards (no transfusion within 14 days) :

      1. Hemoglobin (Hb) ≥85g/L;
      2. Absolute Neutrophil Count (ANC) ≥1.5×109/L;
      3. Platelet (PLT) ≥80×109/L；

    2. Biochemical examination shall meet the following standards:

      1. Total bilirubin (TBIL) ≤1.5 times the upper limit of normal (ULN);
      2. Alanine transferase (ALT) and Aspartate transferase (AST) ≤2.5×ULN; If accompanied by liver metastasis, ALT and AST ≤5×ULN；
      3. Serum creatinine (Cr) ≤1.5×ULN or Creatinine clearance rate (CCr) ≥60ml/min；
  • Female patients of reproductive age should agree that birth control (such as intrauterine device, birth control pills, or condoms) must be used during the study period until six months after completion; Having a negative serum pregnancy test within 7 days prior to study enrollment, and must be non-lactating; Male patients should agree to use contraception during the study period until six months after the end of the study.

Exclusion Criteria:

  • Complicated diseases and history:

    1. Patients currently have or had other malignancies within 3 years. Patients with the following two conditions can be included in the group: Continuous 5-year disease-free survival (DFS) was achieved for other malignancies treated with a single operation. Cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (the tumor infiltrates the basal membrane)];
    2. Major surgical treatment, open biopsy, or significant traumatic injury were received within 28 days before the beginning of the treatment;

    3. Subjects with any severe and/or uncontrolled disease, including:

      1. Having ≥ grade 2 myocardial ischemia or myocardial infarction or arrhythmia (including QTc ≥450ms (male), QTc ≥470ms (female) and ≥ grade 2 congestive heart failure (classified by New York heart association, NYHA));
      2. Active or uncontrolled severe infection (≥ Common Terminology Criteria for Adverse Events (CTC AE) 2 grade of infection);
      3. Renal failure requiring hemodialysis or peritoneal dialysis;
  • Patients with concomitant diseases that, in the investigator's judgment, may seriously endanger patients' safety or may interfere with the completion of the study, or are deemed unsuitable for inclusion for other reasons.
  • Patients who have previously used anlotinib hydrochloride capsules or similar Vascular Endothelial Growth Factor- Tyrosine Kinase Inhibitor (VEGFR-TKI) small molecule drugs, such as vandetanib, cabozantinib, lenvatinib, sunitinib, sorafenib, etc.;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Anlotinib capsules
Anlotinib: 12 mg once daily for 2 weeks, followed by a discontinuance of 1 week (21-daya as a cycle)
Drug: Anlotinib Hydrochloride Capsule
Anlotinib hydrochloride is a muti-target tyrosine kinase inhibitor that inhibits both tumor angiogenesis and tumor cell proliferation simultaneously.
No Intervention: Observation
Observational group: prospectively and retrospectively collect data for patients who did not receive anlotinib hydrochloride capsules or similar small-molecule antivascular inhibitors (including Rearranged during transfection (RET) inhibitors, etc.).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Response Rate (ORR)
Time Frame: Baseline up to 3 years.
The proportion of subjects who achieves a best overall response of complete response (CR) or partial response (PR).
Baseline up to 3 years.
Progression-free Survival (PFS)
Time Frame: Baseline up to 3 years.
From the first dose of investigational drug to the date of disease progression or death, whichever occurs first.
Baseline up to 3 years.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-control Rate (DCR)
Time Frame: Baseline up to 3 years.
The proportion of subjects response of CR, PR, or stable disease (SD) (subjects achieving SD will be included in the DCR if they maintain SD for ≥4 weeks).
Baseline up to 3 years.
Duration of Response (DOR)
Time Frame: Baseline up to 3 years.
From the date that CR or PR are first occurred to the date of disease progression or death, whichever occurs first.
Baseline up to 3 years.
Overall Survival (OS)
Time Frame: Baseline up to death event, up to 3 years.
From randomization to the time of death from any cause.
Baseline up to death event, up to 3 years.
Adverse event rate
Time Frame: Baseline up to 3 years.
The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs).
Baseline up to 3 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 19, 2023

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

April 14, 2023

First Submitted That Met QC Criteria

April 14, 2023

First Posted (Actual)

April 26, 2023

Study Record Updates

Last Update Posted (Actual)

July 25, 2023

Last Update Submitted That Met QC Criteria

July 24, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALOT-MTC-1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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