Gastric CancerPhase 2/3NCT02461407
Study of Anlotinib in Patients With Gastric Cancer(ALTER0503)
A Phase 2/3 study testing Anlotinib in people with Gastric Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 38 sites in China.
Trial summary
The purpose of this study is to compare the effects and safety of Anlotinib with placebo in patients with Gastric Cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Anlotinib
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 378 participants
- Where
- 38 sitesChina
- Study dates
- Jun 2015to Dec 2017
- Phase
- Phase 2/3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed and dated informed consent;
- Pathologically confirmed advanced gastric adenocarcinoma (including Gastroesophageal junction adenocarcinoma) with measurable lesions outside stomach (RECIST 1.1)
- Advanced stomach cancer patients who have failed to the second line or higher line chemotherapy treatment
- >=18 years old；ECOG PS：0~1；Estimated life expectancy >3 months
- Main organs function is normal;
Who cannot join
- Patients who have been treated with anlotinib previously;
- Patients who have been treated with other VEGFR-TKI small-molecule drugs previously, such as sunitinib, Sorafenib, famitinib, Apatinib, Regorafenib, ect
- Patients suffering from other malignancies currently or within 5 years, except for cured cervical carcinoma in situ, non-melanoma skin cancers and superficial bladder cancer [ Ta (non-invasive carcinoma), Tis (carcinoma in situ) and T1 (carcinoma invasion into lamina propria) ]
- Systemic anti-cancer therapy scheduled 4 weeks prior to assignment or during this study，including cytotoxic therapy，signal transduction inhibitors，immunotherapy(or received mitomycin C within 6 weeks before this study). Extended field radiotherapy(EF-RT) used within 4 weeks prior to assignment or limited field radiotherapy used to assess tumor lesions within 2 weeks prior to assignment;
- CTCAE(4.0) Grade 1 or higher non-remission toxicity induced by any other previous treatments，excluding alopecia and Grade 2 or lower neurotoxicity induced by oxaliplatin;
- Patients with a clear tendency of gastrointestinal bleeding;
Show all 15Show fewer
- Patients with factors that could affect oral medication (such as dysphagia，chronic diarrhea etc.)
- Patients with pleural effusion or ascites, causing respiratory syndrome (CTCAE Grade 2 or higher dyspnea [Grade 2 dyspnea refers to Shortness of breath with a small amount of activities, affecting Instrumental activities of daily life])
- Patients with any severe and/or unable to control diseases;
- Patients underwent major surgical treatment，open biopsy or significant traumatic injury within 28 days prior to assignment;
- Patients with any physical signs of bleeding diathesis or medical history, no matter how serious degree they are; Patients with any CTCAE Grade 3 or higher bleeding events occurred within 4 weeks prior to assignment; Patients with non-healing wounds，ulcers or fractures;
- Patients with arterial or venous thromboembolic events occurred within 6 months, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism;
- Patients with drug abuse history and unable to get rid of or Patients with mental disorders
- Brain metastases patients with symptoms or symptoms controlled < 2 months;
- Patients participated in other anticancer drug clinical trials within 4 weeks or Patients participating in other clinical trials now;
Trial locations and contacts
38 sites in 1 country.
Ruihua Xu, Doctor contact
Shen Lin, Doctor contact
38 sites in 1 country
China38 sites, 38 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Lin Shen, Doctor
- Recruiting
The 307th Hospital of Chinese People's Liberation Army
Beijing, Beijing Municipality
Jianming Xu, doctor
Jianming Xu, doctor
- Recruiting
Jilin Cancer Hospital
Changchun, Jilin, 132000
Ying Chen, Doctor
- Not yet recruiting
Xiangya Hospital Central South University
Changsha, Hunan, 410008
Meizuo Zhong, Doctor
- Not yet recruiting
The Third Xiangya Hospital Central South University
Changsha, Hunan, 410013
Peiguo Cao, Doctor
- Recruiting
Hunan Province Tumor Hospital
Changsha, Hunan
Xianli Yin, Doctor
- Recruiting
The First People's Hospital of Changzhou
Changzhou, Jiangsu, 213003
Changping Wu, Doctor
- Recruiting
Chongqing Daping Hospital
Chongqing, Chongqing Municipality, 400042
Dong Wang, Doctor
- Recruiting
Union Hospital of Fujian Medical University
Fuzhou, Fujian, 350001
Xiaoyan Lin, Doctor
- Not yet recruiting
Fujian Cancer Hospital
Fuzhou, Fujian
Zengqing Guo, doctor
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Ruihua Xu, Doctor
- Recruiting
Sir Run Run Shaw Hospital School of Medical,Zhejiang University
Hangzhou, Zhejiang, 310016
Hongming Pan, Doctor
- Recruiting
Harbin medical university affiliated tumor hospita
Harbin, Heilongjiang
Yanqiao Zhang, Doctor
- Recruiting
The First Affiliated Hospital, Anhui Medical University
Hefei, Anhui
Kangsheng Gu, doctor
- Recruiting
The General Hospital of Nanhua University
Hengyang, Hunan, 421001
Wenxiang Dai, Doctor
- Recruiting
Shandong Tumor Hospital
Jinan, Shandong, 250117
Changzheng Li, Doctor
- Recruiting
Yunnan Province Tumor Hospital
Kunming, Yunnan
Jian Dong, Doctor
- Recruiting
Lanzhou General Hospital
Lanzhou, Gansu, 730070
Baihong Zhang, Doctor
- Recruiting
Linyi City Tumor Hospita
Linyi, Shandong
Jianhua Shi, Doctor
- Recruiting
Henan Province Tumor Hospital
Luoyan, Henan
Xiaobing Chen, Doctor
- Recruiting
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
Jianping Xiong, Doctor
- Not yet recruiting
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
Anwen Liu, Doctor
- Not yet recruiting
Jiangxi Cancer Hospital
Nanchang, Jiangxi
Yiye Wan, doctor
Yiye Wan, doctor
- Not yet recruiting
Jiangsu Cancer Hospital
Nanjing, Jiangsu
Jianwei Lu, doctor
- Recruiting
Jiangsu Province Hospital
Nanjing, Jiangsu
Yongqian Shu, doctor
Yongqian Shu, doctor
- Recruiting
The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, 530021
Kehe Chen, Doctor
- Recruiting
Nantong Cancer Hospital
Nantong, Jiangsu
Weidong Yao, doctor
- Not yet recruiting
Fudan University Zhongshan Hospital
Shanghai, Shanghai Municipality, 200032
Tianshu Liu, Doctor
- Not yet recruiting
Shanghai General Hospital
Shanghai, Shanghai Municipality, 200080
Liwei Wang, Doctor
- Not yet recruiting
Cancer Hospital of Fudan University
Shanghai, Shanghai Municipality
Jin Li, doctor
Jin Li, doctor
- Recruiting
Liaoning Province Tumor Hospital
Shenyang, Liaoning
Baoli Qin, doctor
Baoli Qin, doctor
- Recruiting
Fourth Hospital of Hebei Medical University Tumor Hospital of Hebei Province
Shijiazhuang, Hebei, 050011
Ruixing Zhang, Doctor
- Not yet recruiting
Tianjin Medical University Cancer Hospital
Tianjin, Tianjin Municipality
Yi Ba, doctor
Yi Ba, doctor
- Recruiting
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality
Diansheng Zhong, Doctor
- Recruiting
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, 430022
Tao Zhang, Doctor
- Recruiting
Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, 430030
Shiying Yu, Doctor
- Recruiting
Tangdu Hospital of The fourth Military Medical University
Xian, Shanxi
Jie Min, doctor
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
Yanru Qin, Doctor
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Multicenter Clinical Trial to Compare the Efficacy and Safety of Anlotinib Versus Placebo in Patients With Gastric Cancer(ALTER0503)
The purpose of this study is to compare the effects and safety of Anlotinib with placebo in patients with Gastric Cancer.
- Conditions
- Gastric Cancer
- Being tested
- Anlotinib, Placebo
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnlotinibDrug
Anlotinib p.o. qd
PlaceboDrug
Placebo p.o. qd
| Study group | Role | What they receive |
|---|---|---|
| Anlotinib | Experimental | Anlotinib QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent Receives: Drug: Anlotinib |
| Placebo | Placebo comparator | Placebo QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
Measured: From randomization until death (up to 24 months)
Secondary outcomes (3)
Progress free survival (PFS)
Measured: each 42 days up to PD or death(up to 24 months)
Objective Response Rate (ORR)
Measured: each 42 days up to intolerance the toxicity or PD (up to 24 months)
Disease Control Rate (DCR)
Measured: each 42 days up to intolerance the toxicity or PD (up to 24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 378 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
- NCT02461407
- Sponsor's protocol ID
- ALTN-05-II
- Status last verified
- Aug 2017
- First submitted
- 1 Jun 2015
- Last updated
- 29 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Multicenter Clinical Trial to Compare the Efficacy and Safety of Anlotinib Versus Placebo in Patients With Gastric Cancer(ALTER0503)
- ClinicalTrials.gov ID
- NCT02461407
- Acronym / sponsor ID
- ALTN-05-II
- Conditions
- Gastric Cancer
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 378 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jun 2015 (actual)
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 3 Jun 2015 (estimated)
- 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.
The purpose of this study is to compare the effects and safety of Anlotinib with placebo in patients with Gastric Cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anlotinib | Experimental | Drug: AnlotinibAnlotinib QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Signed and dated informed consent;
- Pathologically confirmed advanced gastric adenocarcinoma (including Gastroesophageal junction adenocarcinoma) with measurable lesions outside stomach (RECIST 1.1)
- Advanced stomach cancer patients who have failed to the second line or higher line chemotherapy treatment
- >=18 years old；ECOG PS：0~1；Estimated life expectancy >3 months
- Main organs function is normal;
Key exclusion criteria (15 listed)
- Patients who have been treated with anlotinib previously;
- Patients who have been treated with other VEGFR-TKI small-molecule drugs previously, such as sunitinib, Sorafenib, famitinib, Apatinib, Regorafenib, ect
- Patients suffering from other malignancies currently or within 5 years, except for cured cervical carcinoma in situ, non-melanoma skin cancers and superficial bladder cancer [ Ta (non-invasive carcinoma), Tis (carcinoma in situ) and T1 (carcinoma invasion into lamina propria) ]
- Systemic anti-cancer therapy scheduled 4 weeks prior to assignment or during this study，including cytotoxic therapy，signal transduction inhibitors，immunotherapy(or received mitomycin C within 6 weeks before this study). Extended field radiotherapy(EF-RT) used within 4 weeks prior to assignment or limited field radiotherapy used to assess tumor lesions within 2 weeks prior to assignment;
- CTCAE(4.0) Grade 1 or higher non-remission toxicity induced by any other previous treatments，excluding alopecia and Grade 2 or lower neurotoxicity induced by oxaliplatin;
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 |
|---|---|---|
| AnlotinibAnlotinib p.o. qd | Drug | Anlotinib |
| PlaceboPlacebo p.o. qd | Drug | Placebo |
Primary outcome
Overall Survival (OS)
Time frame: From randomization until death (up to 24 months)
3 secondary outcomes
Progress free survival (PFS)
Time frame: each 42 days up to PD or death(up to 24 months)
Objective Response Rate (ORR)
Time frame: each 42 days up to intolerance the toxicity or PD (up to 24 months)
Disease Control Rate (DCR)
Time frame: each 42 days up to intolerance the toxicity or PD (up to 24 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2017.
Related trials for Gastric Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
Not yet recruitingPhase 1
GK01 Cell Therapy in Gastric Cancer With Peritoneal Metastasis
Gastric Cancer (GC)
RecruitingPhase 3
A Study of Neoadjuvant-adjuvant Durvalumab and FLOT Chemotherapy Followed by Adjuvant Durvalumab in Chinese Patients With Resectable GC/GEJC.
Gastric, Esophagogastric Junction
Active, not recruitingEarly Phase 1
Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma
B-ALL, DLBCL
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.
Ruihua Xu, Doctor contact
Shen Lin, Doctor contact
38 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Anlotinib in people with Gastric Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 38 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 5 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 29 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
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, Doctor (xurh@sysucc.org.cn), 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: From randomization until death (up to 24 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 29 Dec 2017.