Study of Anlotinib in Patients With Advanced Medullary Thyroid Carcinoma

NCT05830500 | Recruiting Phase 4

• 1 other identifier: ALOT-MTC-1
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 19

Brief 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.

Conditions

Medullary Thyroid Cancer

Outcome Measures

Primary Outcomes (2)

• 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.

• 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 Outcomes (4)

• Disease-control Rate (DCR)

  Baseline up to 3 years.

• Duration of Response (DOR)

  Baseline up to 3 years.

• Overall Survival (OS)

  Baseline up to death event, up to 3 years.

• Adverse event rate

  Baseline up to 3 years.

Study Arms (2)

Anlotinib capsules

EXPERIMENTAL

Anlotinib: 12 mg once daily for 2 weeks, followed by a discontinuance of 1 week (21-daya as a cycle)

Drug: Anlotinib Hydrochloride Capsule

Observation

NO INTERVENTION

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.).

Interventions

Anlotinib Hydrochloride Capsule DRUG

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

Anlotinib capsules

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Blood routine examination shall meet the following standards (no transfusion within 14 days) :
• Hemoglobin (Hb) ≥85g/L;
• Absolute Neutrophil Count (ANC) ≥1.5×109/L;
• Platelet (PLT) ≥80×109/L；
• Biochemical examination shall meet the following standards:
• Total bilirubin (TBIL) ≤1.5 times the upper limit of normal (ULN);
• Alanine transferase (ALT) and Aspartate transferase (AST) ≤2.5×ULN; If accompanied by liver metastasis, ALT and AST ≤5×ULN；
• 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.

You may not qualify if:

• Complicated diseases and history:
• 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 \[Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (the tumor infiltrates the basal membrane)\];
• Major surgical treatment, open biopsy, or significant traumatic injury were received within 28 days before the beginning of the treatment;
• Subjects with any severe and/or uncontrolled disease, including:
• 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));
• Active or uncontrolled severe infection (≥ Common Terminology Criteria for Adverse Events (CTC AE) 2 grade of infection);
• Renal failure requiring hemodialysis or peritoneal dialysis;
• 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.;

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: lead

Study Sites (19)

Anhui Provincial Cancer Hospital

Hefei, Anhui, 230031, China

NOT YET RECRUITING

Beijing Tongren Hospital Affiliated to Capital Medical University

Beijing, Beijing Municipality, 100005, China

RECRUITING

Gansu Cancer Hospital

Lanzhou, Gansu, 730050, China

RECRUITING

Guangxi Zhuang Autonomous Region Cancer Hospital (Affiliated Cancer Hospital of Guangxi Medical University)

Nanning, Guangxi, 530021, China

NOT YET RECRUITING

The First Affiliated Hospital of Hebei North University

Shijiazhuang, Hebei, 050051, China

RECRUITING

Tianjin Cancer Hospital

Tianjin, Hebei, 300181, China

RECRUITING

Henan Cancer Hospital

Zhengzhou, Henan, 450003, China

RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

RECRUITING

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

RECRUITING

Hubei Cancer Hospital

Wuhan, Hubei, 430079, China

RECRUITING

Hunan Cancer Hospital

Changsha, Hunan, 410031, China

NOT YET RECRUITING

Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University

Nanjing, Jiangsu, 210008, China

RECRUITING

Jiangsu North People's Hospital

Yangzhou, Jiangsu, 225003, China

RECRUITING

Liaoning Cancer Hospital and Institute

Shenyang, Liaoning, 110801, China

RECRUITING

The First Affiliated Hospital of Xi'an Jiaotong University

Xi’an, Shanxi, 710061, China

RECRUITING

Shanxi Provincial Tumor Hospital

Xi’an, Shanxi, 710065, China

NOT YET RECRUITING

Tianjin People's Hospital

Tianjin, Tianjin Municipality, 300122, China

RECRUITING

The First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, 650032, China

RECRUITING

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, 314408, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Medullary

Condition Hierarchy (Ancestors)

Carcinoma, Neuroendocrine; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Ductal, Lobular, and Medullary; Neoplasms, Nerve Tissue

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2023
• First Posted: April 26, 2023
• Study Start: June 19, 2023
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: July 25, 2023

Record last verified: 2023-04

Locations

CN (19)