Medullary Thyroid CarcinomaPhase 2NCT04787328
A Study of HA121-28 Tablets in Patients With Medullary Thyroid Carcinoma (MTC)
A Phase 2 study testing HA121-28 tablets in people with Medullary Thyroid Carcinoma, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 13 sites in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medullary Thyroid Carcinoma
- What is being tested?
- HA121-28 tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 13 sitesChina
- Study dates
- 13 Jul 2021to Mar 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be willing to participate in the clinical trial and sign the informed consent;
- Men and women aged ≥18 years;
- Histologically confirmed unresectable locally advanced or metastatic MTC with at least one measurable lesion per RECIST1.1;
- Evidence of disease progression within 12 months prior to signing informed consent;
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0~1;
- 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；
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- Left ventricular ejection fraction (LVEF)≥50% in echocardiogram；
- 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;
- Female participants must have negative results of serum/urine pregnancy test within 7 days prior to enrollment and must not be breastfeeding.
Who cannot join
- Previous treatment with selective RET inhibitor, such as blu-667, loxo-292, etc.;
- Patients who had participated in other clinical trials and received the treatment within 4 weeks prior to enrollment;
- Systemic anti-tumor treatment such as small molecule targeted drugs, cytotoxic drugs, immunotherapy and radiotherapy within 4 weeks of the first dose of the study drug, or local palliative radiotherapy for pain relief within 2 weeks;;
- 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;
- 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;
- 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;
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- Urine protein≥2+ and urine protein > 1.0 g/24h;
- Known severe concomitant and/or uncontrolled diseases, including but not limited to: 1)Uncontrolled hypertension (systolic pressure ≥150 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;
- Patients with spinal cord, meningeal and brain metastases (except for stable symptomatic or asymptomatic brain metastases);
- Ongoing adverse events>grade 1 due to any previous treatment at the time of enrollment (except for hair loss and pigmentation);
- Patients who have undergone major surgery or have not recovered from invasive operation within 4 weeks prior to initiation of study treatment;
- Patients with bleeding diathesis (such as active peptic ulcer) or treated with anticoagulants or vitamin K antagonists, such as warfarin, heparin or their analogues;
- 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);
- Patients with known history of neurological or psychiatric disorders, including epilepsy or dementia;
- Not suitable for the study assessed by the investigators.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
China13 sites, 13 recruiting
- Not yet recruiting
Beijing Tongren Hospital
Beijing, Beijing Municipality, 100000
Xiaohong Xiaohong, 13911071002, trchxh@163.com
- Not yet recruiting
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
- Not yet recruiting
Sichuan Cancer Hospital
Chengdu, Sichuan, 610041
Chao Li, 18081892592
- Recruiting
Fujian Cancer Hospital
Fuzhou, Fujian, 350014
Hui Liu, 138 0506 9511, liuhuifj@sina.com
- Recruiting
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, 510080
Ankui Yang, 13903052829, yangak@sysucc.org.cn
- Not yet recruiting
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, 310022
Minghua Ge, 13605813782, gemingh@163.COM
- Not yet recruiting
The First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650032
Ruochuan Cheng, 13708467986, cruochuan@foxmail.com
- Not yet recruiting
Gansu Province Tumor Hospital
Lanzhou, Gansu, 730000
Qinjiang Liu, 13519607327
- Not yet recruiting
Jiangsu province tumor hospital
Nanjing, Jiangsu
Yuan Zhang, 13915990202, ctc@jszlyy.com.cn
- Not yet recruiting
Cancer Hospital of Fudan University
Shanghai, Shanghai Municipality, 200032
Yu Wang, 13817311886, neck130@hotmail.com
- Not yet recruiting
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300600
Xiangqian Zheng, 13820881516, headandneck2007@aliyun.com
- Recruiting
Tianjin People's Hospital
Tianjin, Tianjin Municipality, 300600
Ming Gao, PhD, 022-27557550, gming68@aliyun.com
- Not yet recruiting
Henan Province Tumor Hospital
Zhengzhou, Henan, 450003
Jianwu Qin, 13598802366, qinjianwu62@163.com
About this study
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)
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).
Read the 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 450 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, an additional ECG will be observed two weeks after the first dose, 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.
- Conditions
- Medullary Thyroid Carcinoma
- Being tested
- HA121-28 tablets
- Medical subject headings
- Carcinoma, Medullary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HA121-28 tabletsDrug
HA121-28 450 mg, po, QD×21 days, every 4 weeks (28 days)
| Study group | Role | What they receive |
|---|---|---|
| HA121-28 tablets | Experimental | Patients will receive HA121-28 tablets at 450 mg once daily (QD) for 21 days on a 28-day treatment cycle. Receives: Drug: HA121-28 tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective remission rate (ORR)
assessed approximately every 8 weeks or 12 weeks based on the treatment cycle
Measured: 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
Secondary outcomes (7)
Progression-free survival (PFS)
assessed approximately every 8 weeks or 12 weeks based on the treatment cycle
Measured: From date of randomization until the date of first documented progression, assessed up to 60 months
Duration of response (DOR)
assessed approximately every 8 weeks or 12 weeks based on the treatment cycle
Measured: 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
Overall survival (OS)
assessed approximately every 12 weeks
Measured: From date of randomization until date of death from any cause, assessed up to 60 months
Disease control rate (DCR)
assessed approximately every 8 weeks or 12 weeks based on the treatment cycle
Measured: 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
Changes in blood calcitonin
assessed approximately every 8 weeks
Measured: 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
Adverse events incidence
assessed approximately every 4 weeks
Measured: From date of randomization until the date of death from any cause, assessed up to 60 months
Plasma drug concentration
assessed approximately every 4 weeks
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2021
- Study start13 Jul 2021
- Primary completionMar 2023 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medullary Thyroid CarcinomaStudies of the same condition, open and under way.
- More trials run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wen Xu, Master, Study director, CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04787328
- Sponsor's protocol ID
- HA122-CSP-003
- Status last verified
- Feb 2022
- First submitted
- 24 Feb 2021
- Last updated
- 23 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04787328
- Acronym / sponsor ID
- HA122-CSP-003
- Conditions
- Medullary Thyroid Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 13 Jul 2021 (actual)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 8 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 450 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, an additional ECG will be observed two weeks after the first dose, 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HA121-28 tablets | Experimental | Drug: HA121-28 tabletsPatients will receive HA121-28 tablets at 450 mg once daily (QD) for 21 days on a 28-day treatment cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Be willing to participate in the clinical trial and sign the informed consent;
- Men and women aged ≥18 years;
- Histologically confirmed unresectable locally advanced or metastatic MTC with at least one measurable lesion per RECIST1.1;
- Evidence of disease progression within 12 months prior to signing informed consent;
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0~1;
Key exclusion criteria (15 listed)
- Previous treatment with selective RET inhibitor, such as blu-667, loxo-292, etc.;
- Patients who had participated in other clinical trials and received the treatment within 4 weeks prior to enrollment;
- Systemic anti-tumor treatment such as small molecule targeted drugs, cytotoxic drugs, immunotherapy and radiotherapy within 4 weeks of the first dose of the study drug, or local palliative radiotherapy for pain relief within 2 weeks;;
- 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;
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HA121-28 tabletsHA121-28 450 mg, po, QD×21 days, every 4 weeks (28 days) | Drug | HA121-28 tablets |
Primary outcome
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
7 secondary outcomes
Progression-free survival (PFS)
Time frame: From date of randomization until the date of first documented progression, assessed up to 60 months
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
Overall survival (OS)
Time frame: From date of randomization until date of death from any cause, assessed up to 60 months
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
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
Adverse events incidence
Time frame: From date of randomization until the date of death from any cause, assessed up to 60 months
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wen Xu, Master study director
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HA121-28 tablets in people with Medullary Thyroid Carcinoma, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 13 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ming Gao, PhD (022-27557550, gming68@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2022.