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A Study of HA121-28 Tablets in Patients With Medullary Thyroid Carcinoma (MTC)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04787328
Recruitment Status : Recruiting
First Posted : March 8, 2021
Last Update Posted : July 27, 2021
Sponsor:
Information provided by (Responsible Party):
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Brief Summary:
This is a single-arm, open-label, multicenter study designed to evaluate the preliminary antineoplastic activity, safety and tolerability of HA121-28 tablets administered orally in patients with medullary thyroid cancer (MTC).

Condition or disease Intervention/treatment Phase
Medullary Thyroid Carcinoma Drug: HA121-28 tablets Phase 2

Detailed Description:
A total of approximately 30 patients with MTC will be enrolled. The patients will undergo a 3 weeks-on and 1week-off treatment scheme with HA121-28 tablets 600 mg orally once daily in the 28-day cycle until disease progression or intolerable toxic reaction, whichever occurs first. During the administration of HA121-28 tablets, vital signs, physical examination, ECOG performance status, hematology and chemistry test, ECG, adverse events and concomitant drugs will be evaluated every four weeks, calcitonin and pregnancy test will be performed every 8 weeks. CT for tumor assessment will be performed every 8 weeks for the first year, and every 12 weeks thereafter.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single-arm, Open-Label, Multicenter Phase II Study to Evaluate the Efficacy and Safety of HA121-28 Tablets in Patients With Medullary Thyroid Carcinoma (MTC)
Actual Study Start Date : July 13, 2021
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : March 2025


Arm Intervention/treatment
Experimental: HA121-28 tablets
Patients will receive HA121-28 tablets at 600 mg once daily (QD) for 21 days on a 28-day treatment cycle.
Drug: HA121-28 tablets
HA121-28 600 mg, po, QD×21 days, every 4 weeks (28 days)




Primary Outcome Measures :
  1. Objective remission rate (ORR) [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause,whichever came first, assessed up to 60 months ]
    assessed approximately every 8 weeks or 12 weeks based on the treatment cycle


Secondary Outcome Measures :
  1. Progression-free survival (PFS) [ Time Frame: From date of randomization until the date of first documented progression, assessed up to 60 months ]
    assessed approximately every 8 weeks or 12 weeks based on the treatment cycle

  2. Duration of response (DOR) [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause,whichever came first, assessed up to 60 months ]
    assessed approximately every 8 weeks or 12 weeks based on the treatment cycle

  3. Overall survival (OS) [ Time Frame: From date of randomization until date of death from any cause, assessed up to 60 months ]
    assessed approximately every 12 weeks

  4. Disease control rate (DCR) [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause,whichever came first, assessed up to 60 months ]
    assessed approximately every 8 weeks or 12 weeks based on the treatment cycle

  5. Changes in blood calcitonin [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, or date of death from any cause,whichever came first, assessed up to 60 months ]
    assessed approximately every 8 weeks

  6. Adverse events incidence [ Time Frame: From date of randomization until the date of death from any cause, assessed up to 60 months ]
    assessed approximately every 4 weeks

  7. Plasma drug concentration [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, wihichever came first, assessed up to 60 months ]
    assessed approximately every 4 weeks



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. Be willing to participate in the clinical trial and sign the informed consent;
  2. Men and women aged ≥18 years;
  3. Histologically confirmed unresectable locally advanced or metastatic MTC with at least one measurable lesion per RECIST1.1;
  4. Evidence of disease progression within 12 months prior to signing informed consent;
  5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0~1;
  6. Laboratory test results must meet the following criteria: Absolute neutrophil count (ANC) ≥1.5 x 10^9/L; Platelet count (PLT) ≥75×10^9/L; Hemoglobin (Hb) ≥90 g/L; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 x upper limit of normal (ULN) (in patients with liver metastasis ≤5.0 x ULN); Total bilirubin ≤ 1.5 x ULN; Serum creatinine≤ 1.5 x ULN;Prothrombin time (PT) and activated Partial Thromboplastin Time (APTT) ≤ 1.5 x ULN;
  7. Left ventricular ejection fraction (LVEF)≥50% in echocardiogram;
  8. Male and female subjects of childbearing potential must agree to take effective contraception during the treatment period and for 6 months after the last dose of study medication;
  9. Female participants must have negative results of serum/urine pregnancy test within 7 days prior to enrollment and must not be breastfeeding.

Exclusion Criteria:

  1. Previous treatment with selective RET inhibitor, such as blu-667, loxo-292, etc.;
  2. Patients who had participated in other clinical trials and received the treatment within 4 weeks prior to enrollment;
  3. Systemic anti-tumor treatment such as small molecule targeted drugs, cytotoxic drugs, immunotherapy and radiotherapy within 3 months of the first dose of the study drug, or local palliative radiotherapy for pain relief within 2 weeks;;
  4. Patients who cannot swallow or have chronic diarrhea (except for those induced by MTC) and intestinal obstruction, or other factors which may affect the administration and absorption of the study drug;
  5. History of other malignancies within the past 5 years or currently suffering from other malignancies, except for cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumor;
  6. Patients who meet one of the following criteria: 1) Corrected QT (QTc) ≥450 ms (corrected using Fridericia's formula (QTcF): QTcF = QT/(RR^0.33)); 2) Any clinically significant abnormalities of rhythm, conduction or morphology in the resting electrocardiogram (ECG) requiring therapeutic intervention;
  7. Urine protein≥2+ and urine protein > 1.0 g/24h;
  8. Known severe concomitant and/or uncontrolled diseases, including but not limited to: 1)Uncontrolled hypertension (systolic pressure ≥160 mmHg or diastolic pressure ≥100 mmHg, after treatment); 2)Significant cardiovascular and cerebrovascular events, arterial or venous fistulae thrombotic events, myocardial infarction, congestive heart failure (NYHA classification ≥2) or severe ventricular arrhythmia within 6 months of the first dose of the study drug; 3) Liver cirrhosis, decompensated liver disease; 4) Renal failure required hemodialysis or peritoneal dialysis; 5) History of human immunodeficiency, including HIV positive, or other acquired/congenital immune deficiency diseases, or history of organ or bone marrow transplantation; 6) Uncontrolled pericardial effusion, pleural effusion or ascites;7) interstitial pneumonia required steroid therapy or severe infection required systemic treatment, which is judged not suitable for the study by the investigator;
  9. Patients with spinal cord, meningeal and brain metastases (except for stable symptomatic or asymptomatic brain metastases);
  10. Ongoing adverse events>grade 1 due to any previous treatment at the time of enrollment (except for hair loss and pigmentation);
  11. Patients who have undergone major surgery or have not recovered from invasive operation within 4 weeks prior to initiation of study treatment;
  12. Patients with bleeding diathesis (such as active peptic ulcer) or treated with anticoagulants or vitamin K antagonists, such as warfarin, heparin or their analogues;
  13. Known active Hepatitis B or Hepatitis C virus infection: HBsAg positive with HBV DNA higher than the lower limit of detection range of the site, or HCV antibody positive with HCV RNA higher than the lower limit of detection range of the site);
  14. Patients with known history of neurological or psychiatric disorders, including epilepsy or dementia;
  15. Not suitable for the study assessed by the investigators.

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): NCT04787328


Contacts
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Contact: Ming Gao, PhD 022-27557550 gming68@aliyun.com

Locations
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China, Beijing
Beijing Tongren Hospital Not yet recruiting
Beijing, Beijing, China, 100000
Contact: Xiaohong Xiaohong    13911071002    trchxh@163.com   
Cancer Institute and Hospital, Chinese Academy of Medical Sciences Not yet recruiting
Beijing, Beijing, China, 100021
China, Fujian
Fujian Cancer Hospital Recruiting
Fuzhou, Fujian, China, 350014
Contact: Hui Liu    138 0506 9511    liuhuifj@sina.com   
China, Gansu
Gansu Province Tumor Hospital Not yet recruiting
Lanzhou, Gansu, China, 730000
Contact: Qinjiang Liu    13519607327      
China, Guangdong
Sun Yat-Sen University Cancer Center Recruiting
Guangzhou, Guangdong, China, 510080
Contact: Ankui Yang    13903052829    yangak@sysucc.org.cn   
China, Henan
Henan Province Tumor Hospital Not yet recruiting
Zhengzhou, Henan, China, 450003
Contact: Jianwu Qin    13598802366    qinjianwu62@163.com   
China, Jiangsu
Jiangsu province tumor hospital Not yet recruiting
Nanjing, Jiangsu, China
Contact: Yuan Zhang    13915990202    ctc@jszlyy.com.cn   
China, Shanghai
Cancer Hospital of Fudan University Not yet recruiting
Shanghai, Shanghai, China, 200032
Contact: Yu Wang    13817311886    neck130@hotmail.com   
China, Sichuan
Sichuan Cancer Hospital Not yet recruiting
Chengdu, Sichuan, China, 610041
Contact: Chao Li    18081892592      
China, Tianjin
Tianjin Medical University Cancer Institute and Hospital Not yet recruiting
Tianjin, Tianjin, China, 300600
Contact: Xiangqian Zheng    13820881516    headandneck2007@aliyun.com   
Tianjin People's Hospital Recruiting
Tianjin, Tianjin, China, 300600
Contact: Ming Gao, PhD    022-27557550    gming68@aliyun.com   
China, Yunnan
The First Affiliated Hospital of Kunming Medical University Not yet recruiting
Kunming, Yunnan, China, 650032
Contact: Ruochuan Cheng    13708467986    cruochuan@foxmail.com   
China, Zhejiang
Zhejiang Provincial People's Hospital Not yet recruiting
Hangzhou, Zhejiang, China, 310022
Contact: Minghua Ge    13605813782    gemingh@163.COM   
Sponsors and Collaborators
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Investigators
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Study Director: Wen Xu, Master CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
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Responsible Party: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
ClinicalTrials.gov Identifier: NCT04787328    
Other Study ID Numbers: HA122-CSP-003
First Posted: March 8, 2021    Key Record Dates
Last Update Posted: July 27, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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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Thyroid Neoplasms
Carcinoma, Neuroendocrine
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Carcinoma
Thyroid Diseases
Endocrine System Diseases
Adenocarcinoma