Advanced Gastric and Gastro-oesophageal Junction AdenocarcinomaPhase 3NCT04385550
A Study of Anlotinib Hydrochloride Capsule Combined With AK105 Injection in Subject With Advanced Gastric and Gastro-oesophageal Junction Adenocarcinoma
A Phase 3 study testing Anlotinib hydrochloride capsule, AK105 injection and Paclitaxel injection in people with Advanced Gastric and Gastro-oesophageal Junction Adenocarcinoma, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 45 sites in China.
Trial summary
This is a randomized, controlled, open-label, multicenter study to evaluate efficacy of AK105 injection combined with Anlotinib Hydrochloride Capsules versus standard second-line chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Gastric and Gastro-oesophageal Junction Adenocarcinoma
- What is being tested?
- Anlotinib hydrochloride capsule, AK105 injection and Paclitaxel injection
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 528 participants
- Where
- 45 sitesChina
- Study dates
- 20 May 2020to 31 Dec 2023
- Phase
- Phase 3
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Understood and signed an informed consent form; 2.Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; Life expectancy ≥ 3 months; 3. Histopathology or cytology confirmed as metastatic or local advanced gastric and gastro-oesophageal junction adenocarcinoma; 4. First-line standard chemotherapy regimen in patients with advanced gastric or gastroesophageal junction adenocarcinoma after treatment failure; 5. Has at least one measurable lesion; 6. Weight ≥40 kg or BMI ≥18.5; 7. Adequate organ function; 8. Male or female subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 6 months after the last dose of study (such as intrauterine devices , contraceptives or condoms) ;No pregnant or breastfeeding women, and a negative pregnancy test are received within 7 days before the randomization.
Who cannot join
- 1. Histopathology confirmed as squamous cell carcinoma, carcinoid, undifferentiated carcinoma, or other gastric cancer; 2. HER2 positive; 3. Has received paclitaxel or docetaxel in the first-line treatment; 4. Has received paclitaxel or docetaxel in the neoadjuvant or adjuvant treatment regimen and have relapsed or metastasized within 6 months after the last dose; 5. Has other malignant tumors within 5 years; 6. Has used anti-angiogenic drugs such as anlotinib, apatinib, lenvatinib, sorafenib, sunitinib, bevacizumab, or related immunotherapy drugs for PD-1, PD-L1, etc; 7. Severe hypersensitivity after administration of other monoclonal antibodies; 8. Has spinal cord compression, cancerous meningitis and symptomatic brain metastasis； 9. Has adverse events caused by previous therapy except alopecia that did not recover to ≤grade 1; 10. Has received radiotherapy, chemotherapy and surgery within 4 weeks before the first dose; 11. Has gastrointestinal bleeding tendency within 4 weeks before the first dose; 12. The tumor has invaded important blood vessels and will cause fatal bleeding; 13. Has multiple factors affecting oral medication; 14. Has uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage; 15. Has any active autoimmune disease or history of autoimmune disease; 16. Immunosuppressant or systemic or absorbable local hormone therapy is required to achieve the aim of immunosuppression (dose \> 10mg/ day prednisone or other therapeutic hormones) and is still used within 2 weeks after the first administration; 17. Has any serious and / or uncontrolled disease; 18. Has active viral infection; 19. Has participated in other anticancer drug clinical trials within 4 weeks; 20. According to the judgement of the investigators, there are other factors that may lead to the termination of the study.
Trial locations and contacts
45 sites in 1 country.
45 sites in 1 country
China45 sites
AnYang Tumor Hospital
Anyang, Henan, 455000
Tao Wu, wuren909@163.com
Tao Wu
Beijing Shijitan Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, 100038
Jirun Peng, Doctor, 1446316766@qq.com
Jirun Peng, Doctor
The Sixth Medical Center of PLA General Hospital
Beijing, Beijing Municipality, 100048
Xinhong Zhang, Doctor, zhangxh1970@sina.com
Xinhong Zhang, Doctor
Peking University Shougang Hospital
Beijing, Beijing Municipality, 100144
Delin Wang, dlwang163@sohu.com
Delin Wang
Beijing Luhe Hospital Capital Medical University
Beijing, Beijing Municipality, 101100
Dong Yan, Doctor, yd15yt88@163.com
Dong Yan, Doctor
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, 102218
Zhuo Yu, Doctor, yuzhuo@vip.sina.com
Zhuo Yu, Doctor
Xiangya Hospital Central South University
Changsha, Hunan, 410008
Shan Zeng, Doctor, Shanzeng2012@163.com
Shan Zeng, Doctor
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011
Hongliang Yao, Doctor, yaohl0326@163.com
Hongliang Yao, Doctor
Hunan Cancer Hospital
Changsha, Hunan, 410013
Shanzhi Gu, 105575191@qq.com
Shanzhi Gu
Fujian Provincial Cancer Hospital
Fuzhou, Fujian, 350011
Zengqing Guo
Zengqing Guo
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, 510000
Ruihua Xu, Doctor, ruihxu@163.com
Ruihua Xu, Doctor
The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510610
Yanhong Deng, Doctor
Yanhong Deng, Doctor
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150040
Yanqiao Zhang, Doctor, yanqiaozhang@126.com
Yanqiao Zhang, Doctor
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230022
Kangsheng Gu, Doctor
Kangsheng Gu, Doctor
Shandong Cancer Hospital
Jinan, Shandong, 250117
Changzheng Li, liczdoc@163.com
Changzheng Li
The First People's Hospital of kashi region
Kashgar, XinJiang Uighur Autonomous Region, 844000
Wei Wang, 271865348@qq.com
Wei Wang
The First Hospital of Lanzhou University
Lanzhou, Gansu, 730000
Xiaoming Hou, Doctor, 1795950416@qq.com
Xiaoming Hou, Doctor
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
Junhe Li, Doctor, mailto:lijunhe88@163.com
Junhe Li, Doctor
Jiangsu Cancer Hospital
Nanjing, Jiangsu, 210009
Jianwei Lu, Doctor, lujw@medmail.com.cn
Jianwei Lu, Doctor
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029
Lingjun Zhu, Doctor
Lingjun Zhu, Doctor
Guangxi Medical University Affiliated Tumor Hospital
Nanning, Guangxi, 530021
Jiansi Chen, wcwk0771@126.com
Jiansi Chen
Nantong Cancer Hospital
Nantong, Jiangsu, 226361
Jianhong Wang, ywk_wjh@163.com
Jianhong Wang
Quanzhou First Hospital
Quanzhou, Fujian, 362000
Peiling Xin, xinpeiling62@126.com
Peiling Xin
The Second Affiliated Hospital of Fujian Medical University
Quanzhou, Fujian, 362000
Tianwen Xu, Doctor, xutianwen53@163.com
Tianwen Xu, Doctor
Shanghai General Hospital
Shanghai, Shanghai Municipality, 200080
Qi Li, Doctor, leeqi2001@hotmail.com
Qi Li, Doctor
Liaoning Cancar Hospital
Shenyang, Liaoning, 110042
Baoli Qin, Doctor, poryqin@126.com
Baoli Qin, Doctor
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050010
Da Jiang, jiangda139@163.com
Da Jiang
Shanxi Provincial Cancer Hospital
Taiyuan, Shanxi, 030013
Yusheng Wang, Doctor, wangyusheng1972@163.com
Yusheng Wang, Doctor
Tianjin Medical University General Hospital
Tianjing, Tianjing, 300050
Diansheng Zhong, Doctor, zhongdsh@hotmail.com
Diansheng Zhong, Doctor
Tianjin Medical University Cancer Institute and Hospital
Tianjing, Tianjing, 300060
Yi Ba, Doctor, yiba99@yahoo.com
Yi Ba, Doctor
Union Hospital,Tongji Medical College,Huazhong University of Science and Technology
Wuhan, Hubei, 430022
Tao Zhang, Doctor, 1277577866@qq.com
Tao Zhang, Doctor
Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
Wuhan, Hubei, 430030
Xianglin Yuan, Doctor, xlyuan1020@163.com
Xianglin Yuan, Doctor
Hubei Cancer Hospital
Wuhan, Hubei, 430079
Xinjun Liang, Doctor, doctorlxj@163.com
Xinjun Liang, Doctor
Gansu Wuwei Tumour Hospital
Wuwei, Gansu, 733000
Linzhi Lu, lulinzh12006@163.com
Linzhi Lu
Wuxi People's Hospital
Wuxi, Jiangsu, 214023
Chaoying Liu, chyliu666@163.com
Chaoying Liu
Hospital of Jiangnan University
Wuxi, Jiangsu, 214062
Yong Mao, Doctor, mydoctorwx@aliyun.com
Yong Mao, Doctor
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, 710004
Xi Chen, Doctor, 2002chenxi@163.com
Xi Chen, Doctor
First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, 710061
Enxiao Li, Doctor, doclienxiao@sina.com
Enxiao Li, Doctor
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361003
Jiayi Li, ljy778848@qq.com
Jiayi Li
Zhongshan Hospital Xiamen University
Xiamen, Fujian, 361004
Zhijie Ding, Doctor, zhijieding@sina.com
Zhijie Ding, Doctor
Xinxiang Central Hospital
Xinxiang, Henan, 453000
Guifang Zhang, xxchzhangguifang@126.com
Guifang Zhang
People's Hospital of Ningxia Hui Autonomous Region
Yinchuan, Ningxia, 750021
Qingxin Zhuang, zhuangtse@163.com
Qingxin Zhuang
Affiliated Hospital of Guangdong Medical University
Zhanjiang, Guangdong, 524000
Zhong Xie, xiexieg@126.com
Zhong Xie
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450003
Yanru Qin, Doctor, yanruqin@163.com
Yanru Qin, Doctor
Henan Cancer Hospital
Zhengzhou, Henan, 450008
Huijuan Wu
Huijuan Wu
About this study
Official title: A Randomized, Open-label, Controlled, Multicenter Phase III Study of Hydrochloride Capsule Combined With AK105 Injection Versus Standard Second-line Chemotherapy for Advanced Gastric and Gastro-oesophageal Junction Adenocarcinoma
This is a randomized, controlled, open-label, multicenter study to evaluate efficacy of AK105 injection combined with Anlotinib Hydrochloride Capsules versus standard second-line chemotherapy. Patients are treated with AK105 injection combined with Anlotinib Hydrochloride Capsules or standard second-line chemotherapy, with 1:1 random ratio.
- Being tested
- Anlotinib hydrochloride capsule, AK105 injection, Paclitaxel injection, Docetaxel injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anlotinib hydrochloride capsuleDrug
Anlotinib hydrochloride capsule 12mg given orally in fasting conditions, once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21).
AK105 injectionDrug
AK105 200mg intravenously (IV) on Day 1 of each 21-day cycle.
Paclitaxel injectionDrug
Paclitaxel injection 80mg / m² IV on Days 1, 8 and 15 of each 28-day cycle.
Docetaxel injectionDrug
Docetaxel injection 75mg / m² IV every 3 weeks of each 21-day cycle.
| Study group | Role | What they receive |
|---|---|---|
| Anlotinib hydrochloride capsule + AK105 injection | Experimental | Anlotinib hydrochloride capsule 12mg given orally in fasting conditions, once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21) plus AK105 200mg intravenously (IV) on Day 1 of each 21-day cycle. Receives: Drug: Anlotinib hydrochloride capsule; Drug: AK105 injection |
| Standard Second-line Chemotherapy | Active comparator | Participants receive 80 mg/m² IV paclitaxel on Days 1, 8 and 15 of each 28-day cycle, or 75mg/m² docetaxel every 3 weeks of each 21-day cycle until disease progression or unacceptable toxicity. Receives: Drug: Paclitaxel injection; Drug: Docetaxel injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
OS defined as the time from randomization to death from any cause. Subjects who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive.
Measured: up to 45 weeks
Secondary outcomes (4)
Progression-free survival (PFS)
PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause.
Measured: up to 45 weeks
Overall response rate (ORR)
Percentage of subjects achieving complete response (CR) and partial response (PR).
Measured: up to 45 weeks
Disease control rate (DCR)
Percentage of subjects achieving complete response (CR) and partial response (PR) and stable disease (SD).
Measured: up to 45 weeks
Duration of response (DOR)
DOR defined as time from earliest date of disease response to earliest date of disease progression based on radiographic assessment.
Measured: up to 45 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2020
- Study start20 May 2020 (estimated)
- Primary completion31 Oct 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Gastric and Gastro-oesophageal Junction AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 528 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04385550
- Sponsor's protocol ID
- ALTN-AK05-III-01
- Status last verified
- Jan 2020
- First submitted
- 9 May 2020
- Last updated
- 13 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Controlled, Multicenter Phase III Study of Hydrochloride Capsule Combined With AK105 Injection Versus Standard Second-line Chemotherapy for Advanced Gastric and Gastro-oesophageal Junction Adenocarcinoma
- ClinicalTrials.gov ID
- NCT04385550
- Acronym / sponsor ID
- ALTN-AK05-III-01
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 528 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 May 2020 (estimated)
- Primary completion
- 31 Oct 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 13 May 2020 (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 randomized, controlled, open-label, multicenter study to evaluate efficacy of AK105 injection combined with Anlotinib Hydrochloride Capsules versus standard second-line chemotherapy. Patients are treated with AK105 injection combined with Anlotinib Hydrochloride Capsules or standard second-line chemotherapy, with 1:1 random ratio.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anlotinib hydrochloride capsule + AK105 injection | Experimental | Drug: Anlotinib hydrochloride capsule, Drug: AK105 injectionAnlotinib hydrochloride capsule 12mg given orally in fasting conditions, once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21) plus AK105 200mg intravenously (IV) on Day 1 of each 21-day cycle. |
| Standard Second-line Chemotherapy | Active comparator | Drug: Paclitaxel injection, Drug: Docetaxel injectionParticipants receive 80 mg/m² IV paclitaxel on Days 1, 8 and 15 of each 28-day cycle, or 75mg/m² docetaxel every 3 weeks of each 21-day cycle until disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Understood and signed an informed consent form; 2.Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; Life expectancy ≥ 3 months; 3. Histopathology or cytology confirmed as metastatic or local advanced gastric and gastro-oesophageal junction adenocarcinoma; 4. First-line standard chemotherapy regimen in patients with advanced gastric or gastroesophageal junction adenocarcinoma after treatment failure; 5. Has at least one measurable lesion; 6. Weight ≥40 kg or BMI ≥18.5; 7. Adequate organ function; 8. Male or female subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 6 months after the last dose of study (such as intrauterine devices , contraceptives or condoms) ;No pregnant or breastfeeding women, and a negative pregnancy test are received within 7 days before the randomization.
Key exclusion criteria (1 listed)
- 1. Histopathology confirmed as squamous cell carcinoma, carcinoid, undifferentiated carcinoma, or other gastric cancer; 2. HER2 positive; 3. Has received paclitaxel or docetaxel in the first-line treatment; 4. Has received paclitaxel or docetaxel in the neoadjuvant or adjuvant treatment regimen and have relapsed or metastasized within 6 months after the last dose; 5. Has other malignant tumors within 5 years; 6. Has used anti-angiogenic drugs such as anlotinib, apatinib, lenvatinib, sorafenib, sunitinib, bevacizumab, or related immunotherapy drugs for PD-1, PD-L1, etc; 7. Severe hypersensitivity after administration of other monoclonal antibodies; 8. Has spinal cord compression, cancerous meningitis and symptomatic brain metastasis； 9. Has adverse events caused by previous therapy except alopecia that did not recover to ≤grade 1; 10. Has received radiotherapy, chemotherapy and surgery within 4 weeks before the first dose; 11. Has gastrointestinal bleeding tendency within 4 weeks before the first dose; 12. The tumor has invaded important blood vessels and will cause fatal bleeding; 13. Has multiple factors affecting oral medication; 14. Has uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage; 15. Has any active autoimmune disease or history of autoimmune disease; 16. Immunosuppressant or systemic or absorbable local hormone therapy is required to achieve the aim of immunosuppression (dose \> 10mg/ day prednisone or other therapeutic hormones) and is still used within 2 weeks after the first administration; 17. Has any serious and / or uncontrolled disease; 18. Has active viral infection; 19. Has participated in other anticancer drug clinical trials within 4 weeks; 20. According to the judgement of the investigators, there are other factors that may lead to the termination of the study.
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 |
|---|---|---|
| Anlotinib hydrochloride capsuleAnlotinib hydrochloride capsule 12mg given orally in fasting conditions, once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21). | Drug | Anlotinib hydrochloride capsule + AK105 injection |
| AK105 injectionAK105 200mg intravenously (IV) on Day 1 of each 21-day cycle. | Drug | Anlotinib hydrochloride capsule + AK105 injection |
| Paclitaxel injectionPaclitaxel injection 80mg / m² IV on Days 1, 8 and 15 of each 28-day cycle. | Drug | Standard Second-line Chemotherapy |
| Docetaxel injectionDocetaxel injection 75mg / m² IV every 3 weeks of each 21-day cycle. | Drug | Standard Second-line Chemotherapy |
Primary outcome
Overall survival (OS)
Time frame: up to 45 weeks
OS defined as the time from randomization to death from any cause. Subjects who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive.
4 secondary outcomes
Progression-free survival (PFS)
Time frame: up to 45 weeks
Overall response rate (ORR)
Time frame: up to 45 weeks
Disease control rate (DCR)
Time frame: up to 45 weeks
Duration of response (DOR)
Time frame: up to 45 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2020.
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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.
45 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Anlotinib hydrochloride capsule, AK105 injection and Paclitaxel injection in people with Advanced Gastric and Gastro-oesophageal Junction Adenocarcinoma, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 45 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 1 inclusion and 1 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 13 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Ruihua Xu (020-87343468, ruihxu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (OS) (time frame: up to 45 weeks). 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 13 May 2020.