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

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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.

Tracking Information
First Submitted Date  ICMJE February 24, 2021
First Posted Date  ICMJE March 8, 2021
Last Update Posted Date July 27, 2021
Actual Study Start Date  ICMJE July 13, 2021
Estimated Primary Completion Date March 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 5, 2021)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 5, 2021)
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of HA121-28 Tablets in Patients With Medullary Thyroid Carcinoma (MTC)
Official Title  ICMJE 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)
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).
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Medullary Thyroid Carcinoma
Intervention  ICMJE Drug: HA121-28 tablets
HA121-28 600 mg, po, QD×21 days, every 4 weeks (28 days)
Study Arms  ICMJE 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.
Intervention: Drug: HA121-28 tablets
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 5, 2021)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2025
Estimated Primary Completion Date March 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ming Gao, PhD 022-27557550 gming68@aliyun.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04787328
Other Study ID Numbers  ICMJE HA122-CSP-003
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Study Sponsor  ICMJE CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Wen Xu, Master CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
PRS Account CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP