- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05745363
Clinical Study of AL2846 Capsule in the Treatment of Differentiated Thyroid Cancer
February 27, 2023 updated by: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Phase Ib Clinical Trial to Evaluate the Efficacy and Safety of AL2846 Capsule in Iodine-resistant Differentiated Thyroid Cancer With Previous TKI Treatment Failure
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
20
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Guangxi
-
Guilin, Guangxi, China, 541001
- Recruiting
- Affiliated Hospital of Guilin Medical University
-
Contact:
- Wei Fu, Master
- Phone Number: +86 13977385850
- Email: 13977385850@126.com
-
-
Hunan
-
Changsha, Hunan, China, 410013
- Recruiting
- Hunan Cancer Hospital
-
Contact:
- Feng Shi, Doctor
- Phone Number: +86 13974875587
- Email: shifeng@hnca.org.cn
-
Principal Investigator:
- Feng Shi, Doctor
-
-
Jiangxi
-
Nanchang, Jiangxi, China, 330029
- Recruiting
- Jiangxi Cancer Hospital
-
Contact:
- Zhijun Chen, Master
- Phone Number: +86 13870058573
- Email: zhijunchen361@163.com
-
Principal Investigator:
- Zhijun Chen
-
-
Yunnan
-
Kunming, Yunnan, China, 650011
- Recruiting
- Yunnan Cancer Hospital
-
Contact:
- Zhi-yong Deng, Master
- Phone Number: +86 13888158986
- Email: 13888158986@163.com
-
Principal Investigator:
- Zhi-yong Deng
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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:
- 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);
- The lesions that originally took iodine gradually lost the ability to take iodine after 131I treatment;
- Some lesions in the same patient take iodine, while some lesions do not take iodine, and there is no biochemical remission;
- The focus takes iodine, but the disease progresses within 12 months (confirmed by imaging);
- 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:
- Have undifferentiated thyroid cancer or medullary thyroid cancer;
- Known thyroid cancer with Rearranged during Transfection (RET) fusion positive;
- 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)];
- CTCAE5.0 ≥ grade 2 therapeutic toxicity caused by any previous treatment that has not been completely relieved, excluding hair loss;
- Inability to tolerate multiple factors affecting oral medication due to any reason;
- Major surgical treatment or obvious traumatic injury (excluding puncture for diagnosis, endoscopic biopsy, etc.) was received within 4 weeks before the first administration;
- Wounds or fractures that have not been cured for a long time;
- Arterial/venous thrombosis events occurred within 6 months before the first administration, such as cerebrovascular accident, deep venous thrombosis and pulmonary embolism;
- Those who have a history of abuse of psychotropic substances and are unable to quit or have mental disorders;
Subjects with any severe and/or uncontrollable disease, including:
- Poor blood pressure control (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg);
- 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);
- Active or uncontrolled serious infection (≥ CTCAE grade 2);
- Decompensated stage of liver cirrhosis;
- Renal failure requiring hemodialysis or peritoneal dialysis;
- 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;
- Poor control of diabetes (FBG>10mmol/L);
- Those who have epilepsy and need treatment;
Tumor related symptoms and treatment:
- Have received surgery, chemotherapy, radiotherapy (brain radiotherapy for 2 weeks) or other anti-cancer therapy within 4 weeks before the first administration;
- Participated in clinical trials of other anti-tumor drugs within 4 weeks before the first administration;
- Any type of small-molecule kinase inhibitor has been accepted within 2 weeks before the first administration;
- 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;
- Uncontrolled pleural effusion, pericardial effusion or ascites that still need repeated drainage (judged by the investigators);
Others:
- Vaccination history of live attenuated vaccine within 4 weeks before the first administration or live attenuated vaccine is planned during the study period;
- Allergic to known ingredients of AL2846 capsule;
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: AL2846 capsule
AL2846 capsules monotherapy, 28 days as a treatment cycle.
|
AL2846 is a multi-target tyrosine kinase inhibitor
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective remission rate (ORR)
Time Frame: From baseline up to 12 months.
|
ORR is defined as the percentage of participants with complete remission (CR) and partial remission (PR) based on investigator records.
|
From baseline up to 12 months.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-free survival (PFS)
Time Frame: From baseline up to 12 months.
|
PFS is defined as the time from randomization to the first recorded progressive disease (PD) or death from any cause.
|
From baseline up to 12 months.
|
Disease control rate (DCR)
Time Frame: From baseline up to 12 months.
|
DCR is defined as the percentage of patients who have achieved complete response, partial response and stable disease.
|
From baseline up to 12 months.
|
Duration of remission (DoR)
Time Frame: From baseline up to 12 months.
|
The time from the start of the first evaluation of the tumor as CR or PR to the first assessment as PD or death from any cause.
|
From baseline up to 12 months.
|
Overall survival (OS)
Time Frame: From baseline to death event.
|
Time from the first administration to death due to any cause.
|
From baseline to death event.
|
Occurrence of all adverse events (AEs)
Time Frame: From baseline to 28 days after the last dose or start of a new antineoplastic therapy (whichever comes first).
|
Adverse events are evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0.
|
From baseline to 28 days after the last dose or start of a new antineoplastic therapy (whichever comes first).
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 24, 2023
Primary Completion (Anticipated)
June 1, 2024
Study Completion (Anticipated)
December 1, 2024
Study Registration Dates
First Submitted
February 16, 2023
First Submitted That Met QC Criteria
February 16, 2023
First Posted (Actual)
February 27, 2023
Study Record Updates
Last Update Posted (Estimate)
February 28, 2023
Last Update Submitted That Met QC Criteria
February 27, 2023
Last Verified
November 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AL2846-Ib-02
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Differentiated Thyroid Cancer
-
Thomas Jefferson UniversityActive, not recruitingDifferentiated Thyroid Cancer (DTC) | Poorly Differentiated Thyroid CancerUnited States
-
University of PennsylvaniaCompletedMetastatic Medullary Thyroid Cancer | Metastatic Differentiated Thyroid Cancer | Metastatic Anaplastic Thyroid Cancer | Metastatic Poorly Differentiated Thyroid CancerUnited States
-
National Cancer Institute (NCI)TerminatedThyroid Neoplasms | Differentiated Thyroid Cancer | Poorly Differentiated and Undifferentiated Thyroid CancerUnited States
-
H. Lee Moffitt Cancer Center and Research InstituteTerminatedThyroid Cancer, Medullary | Thyroid Cancer | Papillary Thyroid Cancer | Differentiated Thyroid Cancer | Poorly Differentiated Thyroid Gland Carcinoma | Follicular Thyroid CancerUnited States
-
Children's Hospital of PhiladelphiaBayerRecruitingCancer | Pediatric Cancer | Differentiated Thyroid Cancer | Cancer, ThyroidUnited States
-
Children's Hospital of PhiladelphiaEli Lilly and Company; United States Department of DefenseNot yet recruitingCancer | Pediatric Cancer | Differentiated Thyroid Cancer | Cancer, Thyroid
-
Istituti Clinici Scientifici Maugeri SpAMerck Sharp & Dohme LLCRecruiting
-
National Taiwan University HospitalRecruitingDifferentiated Thyroid CancerTaiwan
-
Suzhou Zelgen Biopharmaceuticals Co.,LtdActive, not recruitingDifferentiated Thyroid CancerChina
-
Genzyme, a Sanofi CompanyCompletedEvaluation of Efficacy, Safety of Vandetanib in Patients With Differentiated Thyroid Cancer (VERIFY)Differentiated Thyroid CancerUnited States, Sweden, Brazil, Italy, Poland, Spain, China, Russian Federation, France, Japan, Denmark, Czechia
Clinical Trials on AL2846 capsule
-
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.RecruitingOvarian Cancer | Advanced Lung CancerChina
-
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Unknown
-
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.TerminatedNeurofibromatosis and Malignant Peripheral Nerve Sheath TumorsChina
-
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Recruiting
-
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Active, not recruiting
-
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Completed
-
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.UnknownBone Metastatic Non-small Cell Lung CancerChina
-
Quan JiangUnknown
-
Guizhou Bailing Group Pharmaceutical Co LtdWangjing Hospital, China Academy of Chinese Medical Sciences; The First Affiliated... and other collaboratorsUnknownKnee OsteoarthritisChina
-
Third Military Medical UniversityNot yet recruiting