Trial Title:
Clinical Study of AL2846 Capsule in the Treatment of Differentiated Thyroid Cancer
NCT ID:
NCT05745363
Condition:
Differentiated Thyroid Cancer
Conditions: Official terms:
Thyroid Neoplasms
Thyroid Diseases
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
AL2846 capsule
Description:
AL2846 is a multi-target tyrosine kinase inhibitor
Arm group label:
AL2846 capsule
Summary:
This is a Phase Ib clinical trial to evaluate the efficacy and safety of AL2846 capsule
in iodine-refractory differentiated thyroid cancer that has failed previous TKI
treatment. The trial is planned to enroll 20 subjects. The trial is a single-arm,
multi-center, open label clinical study. Objective response rate (ORR) is the primary
endpoint.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Age: 18~80 years old (when signing the informed consent form), regardless of gender;
- Differentiated thyroid carcinoma (DTC) confirmed by histopathology or cytology;
- At least one measurable lesion according to Response Evaluation Criteria in Solid
Tumours (RECIST 1.1);
- Disease progression occurs after receiving at least one (but not more than two)
Vascular Endothelial Growth Factor Receptor (VEGFR) targeted therapy in the past;
- Iodine refractory patients can be defined as iodine refractory if they meet one of
the following conditions:
1. The lesions showed no iodine uptake on the whole body imaging after 131I
treatment, and could not benefit from the follow-up 131I treatment (it must be
confirmed by the endocrinologist or nuclear medicine physician. If there are
too many residual thyroid, it may affect the iodine uptake of the metastatic
lesions, which can be evaluated when the thyroid is removed and treated again);
2. The lesions that originally took iodine gradually lost the ability to take
iodine after 131I treatment;
3. Some lesions in the same patient take iodine, while some lesions do not take
iodine, and there is no biochemical remission;
4. The focus takes iodine, but the disease progresses within 12 months (confirmed
by imaging);
5. The cumulative dosage of 131I ≥ 600mCi or 22GBq, but the disease did not
alleviate (confirmed by imaging).
- There was evidence of imaging progress within 14 months before the knowledge;
- Thyroid Stimulating Hormone (TSH) ≤ 0.5mIU/L under the treatment of TSH inhibitor;
- Eastern Cooperative Oncology Group (ECOG) score: 0-1;
- Estimated survival time ≥ 12 weeks;
- Normal function of main organs
- HBsAg positive patients must meet the requirements of Hepatitis B Virus (HBV) DNA
compliance or receive anti-HBV treatment at least one week before the start of the
study, and the virus index is reduced by more than 10 times. At the same time, the
patients are willing to receive anti-HBV treatment throughout the whole study
period; The patients with hepatitis C antibody positive and Hepatitis B Virus (HCV)
RNA quantitative positive should complete antiviral treatment at least 1 month
before starting the study; 12) The serum Human Chorionic Gonadotropin (HCG) test of
female patients of childbearing age must be negative within 7 days before study
enrollment and must be non-lactating; The patient should agree to use contraception
during the study period and within 6 months after the end of the study period; 13)
The patient voluntarily joined the study and signed the informed consent form, with
good compliance.
Exclusion Criteria:
- Combined with the following diseases or medical history:
1. Have undifferentiated thyroid cancer or medullary thyroid cancer;
2. Known thyroid cancer with Rearranged during Transfection (RET) fusion positive;
3. Other malignant tumors have occurred or are present at the same time within<3
years before the first administration. The following two cases can be included
in the group: other malignant tumors treated by single surgery have achieved R0
resection without recurrence and metastasis; Cured cervical carcinoma in situ,
skin basal cell carcinoma and superficial bladder tumor [Ta (non-invasive
tumor), Tis (carcinoma in situ) and T1 (tumor infiltrating basement membrane)];
4. CTCAE5.0 ≥ grade 2 therapeutic toxicity caused by any previous treatment that
has not been completely relieved, excluding hair loss;
5. Inability to tolerate multiple factors affecting oral medication due to any
reason;
6. Major surgical treatment or obvious traumatic injury (excluding puncture for
diagnosis, endoscopic biopsy, etc.) was received within 4 weeks before the
first administration;
7. Wounds or fractures that have not been cured for a long time;
8. Arterial/venous thrombosis events occurred within 6 months before the first
administration, such as cerebrovascular accident, deep venous thrombosis and
pulmonary embolism;
9. Those who have a history of abuse of psychotropic substances and are unable to
quit or have mental disorders;
10. Subjects with any severe and/or uncontrollable disease, including:
1. Poor blood pressure control (systolic blood pressure ≥ 150 mmHg or
diastolic blood pressure ≥ 100 mmHg);
2. Patients with ≥ grade 2 myocardial ischemia or myocardial infarction,
arrhythmia (including male corrected QT interval ≥ 450ms, female corrected
QT interval ≥ 470ms) and ≥ grade 2 congestive heart failure (New York
Heart Association (NYHA) classification);
3. Active or uncontrolled serious infection (≥ CTCAE grade 2);
4. Decompensated stage of liver cirrhosis;
5. Renal failure requiring hemodialysis or peritoneal dialysis;
6. Have a history of immunodeficiency, including HIV-positive or other
acquired and congenital immunodeficiency diseases, have received
allogeneic hematopoietic stem cell transplantation, solid organ
transplantation or have received autologous hematopoietic stem cell
transplantation within 12 weeks before the first administration;
7. Poor control of diabetes (FBG>10mmol/L);
8. Those who have epilepsy and need treatment;
- Tumor related symptoms and treatment:
1. Have received surgery, chemotherapy, radiotherapy (brain radiotherapy for 2
weeks) or other anti-cancer therapy within 4 weeks before the first
administration;
2. Participated in clinical trials of other anti-tumor drugs within 4 weeks before
the first administration;
3. Any type of small-molecule kinase inhibitor has been accepted within 2 weeks
before the first administration;
4. Within 2 weeks before the first administration, he has received the treatment
of traditional Chinese medicine with anti-tumor indications specified in the
drug instructions approved by China National Medical Products Administration;
5. Uncontrolled pleural effusion, pericardial effusion or ascites that still need
repeated drainage (judged by the investigators);
- Others:
1. Vaccination history of live attenuated vaccine within 4 weeks before the first
administration or live attenuated vaccine is planned during the study period;
2. Allergic to known ingredients of AL2846 capsule;
3. According to the judgment of the researcher, there are patients with
concomitant diseases that seriously endanger the safety of the subjects or
affect the completion of the study, or those who think there are other reasons
that are not suitable for inclusion.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Affiliated Hospital Of Guilin Medical University
Address:
City:
Guilin
Zip:
541001
Country:
China
Status:
Recruiting
Contact:
Last name:
Wei Fu, Master
Phone:
+86 13977385850
Email:
13977385850@126.com
Facility:
Name:
Hunan Cancer Hospital
Address:
City:
Changsha
Zip:
410013
Country:
China
Status:
Recruiting
Contact:
Last name:
Feng Shi, Doctor
Phone:
+86 13974875587
Email:
shifeng@hnca.org.cn
Investigator:
Last name:
Feng Shi, Doctor
Email:
Principal Investigator
Facility:
Name:
Jiangxi Cancer Hospital
Address:
City:
Nanchang
Zip:
330029
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhijun Chen, Master
Phone:
+86 13870058573
Email:
zhijunchen361@163.com
Investigator:
Last name:
Zhijun Chen
Email:
Principal Investigator
Facility:
Name:
Yunnan Cancer Hospital
Address:
City:
Kunming
Zip:
650011
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhi-yong Deng, Master
Phone:
+86 13888158986
Email:
13888158986@163.com
Investigator:
Last name:
Zhi-yong Deng
Email:
Principal Investigator
Start date:
February 24, 2023
Completion date:
December 2024
Lead sponsor:
Agency:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Agency class:
Industry
Source:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05745363
