Study of Anlotinib in Patients With Advanced Medullary Thyroid Carcinoma

Medullary Thyroid Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05830500
• Other study ID #: ALOT-MTC-1
• Status: Recruiting
• Phase: Phase 4
• Start date: June 19, 2023
• Est. completion date: December 2028

Study information

• Verified date: April 2023
• Source: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 360
• Est. completion date: December 2028
• Est. primary completion date: June 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.;

Related Conditions & MeSH terms

• Medullary Thyroid Cancer
• Thyroid Diseases
• Thyroid Neoplasms

Intervention

Drug:
• Anlotinib Hydrochloride Capsule
Anlotinib hydrochloride is a muti-target tyrosine kinase inhibitor that inhibits both tumor angiogenesis and tumor cell proliferation simultaneously.

Locations

Country	Name	City	State
China	Beijing Tongren Hospital Affiliated to Capital Medical University	Beijing	Beijing
China	Hunan Cancer Hospital	Changsha	Hunan
China	Zhejiang Provincial People's Hospital	Hangzhou	Zhejiang
China	Anhui Provincial Cancer Hospital	Hefei	Anhui
China	The First Affiliated Hospital of Kunming Medical University	Kunming	Yunnan
China	Gansu Cancer Hospital	Lanzhou	Gansu
China	Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University	Nanjing	Jiangsu
China	Guangxi Zhuang Autonomous Region Cancer Hospital (Affiliated Cancer Hospital of Guangxi Medical University)	Nanning	Guangxi
China	Liaoning Cancer Hospital and Institute	Shenyang	Liaoning
China	The First Affiliated Hospital of Hebei North University	Shijiazhuang	Hebei
China	Tianjin Cancer Hospital	Tianjin	Hebei
China	Tianjin People's Hospital	Tianjin	Tianjin
China	Hubei Cancer Hospital	Wuhan	Hubei
China	Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei
China	Shanxi Provincial Tumor Hospital	Xi'an	Shanxi
China	The First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shanxi
China	Jiangsu North People's Hospital	Yangzhou	Jiangsu
China	Henan Cancer Hospital	Zhengzhou	Henan
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Response Rate (ORR)	The proportion of subjects who achieves a best overall response of complete response (CR) or partial response (PR).	Baseline up to 3 years.
Primary	Progression-free Survival (PFS)	From the first dose of investigational drug to the date of disease progression or death, whichever occurs first.	Baseline up to 3 years.
Secondary	Disease-control Rate (DCR)	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.
Secondary	Duration of Response (DOR)	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.
Secondary	Overall Survival (OS)	From randomization to the time of death from any cause.	Baseline up to death event, up to 3 years.
Secondary	Adverse event rate	The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs).	Baseline up to 3 years.