Non-small Cell Lung CancerPhase 2NCT01924195
Phase II Study of Anlotinib in Patients With Advanced Non-small Cell Lung Cancer（ALTER0302）
A Phase 2 study testing Anlotinib in people with Non-small Cell Lung Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 13 sites in China.
Trial summary
Anlotibib (AL3818) is a kind of innovative medicines approved by State Food and Drug Administration（SFDA:2011L00661） which was researched by Jiangsu Chia-tai Tianqing Pharmaceutical Co., Ltd. Anlotinib is a kinase inhibitor of receptor tyrosine with multi-targets, especially for VEGFR2、VEGFR3、PDGFRβ and c-Kit. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Anlotinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 117 participants
- Where
- 13 sitesChina
- Study dates
- Aug 2013to Oct 2015
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- pathology diagnosed with advanced NSCL with measurable lesions;
- Have failed for 2 lines of chemotherapy;
- 18-70years,ECOG PS:0-2,Life expectancy of more than 3 months;
- Other cytotoxic drugs,radiation therapy,or surgery≥4 weeks;
- main organs function is normal;
- must be agreed to take contraceptive measures during the study and within 6 months after end.
Who cannot join
- SCLC(including mixed with NSCLC);
- the central cavity of Squamous cell carcinoma and hemoptysis with NSCLC;
- patients failed to use the anti-tumor angiogenesis therapy;
- patients has many influence factors toward oral medications ;
- Brain metastases patients accompanied by symptoms or symptom control for less than two months;
- patients with severe and failed to controlled diseases,including: suboptimal blood pressure control;suffering from myocardial ischemia or above grade I myocardial infarction, arrhythmias and Class I heart failure;activity or failure to control severe infections;liver disease such as cirrhosis, decompensated liver disease, chronic active hepatitis;poorly controlled diabetes (FBG)>10mmol/L);urine protein≥++,etc.
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- patients failed to heal wounds or fractures for Long-term;
- 4 weeks before enrollment, patients appeared NCI CTC AE grading >1 pulmonary hemorrhage; 4 weeks before enrollment, patients who appeared NCI CTC AE grade> 2 have other parts of the bleeding; patients has a tendency to bleed (eg active peptic ulcer) or are receiving thrombolytic or anticoagulant therapy such as warfarin, heparin or its analogues;
- patients occurred venous thromboembolic events within 6 months;
- patients has HIV-positive or organ transplantation;
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
China13 sites
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Beijing chest hospital，capital medical university
Beijing, Beijing Municipality, 101149
Jilin province tumor hospital
Changchun, Jilin, 130000
Hunan Province Tumor Hospital
Changsha, Hunan, 410013
West China Hospital,Sichuan University
Chengdu, Sichuan, 610041
Xinqiao Hospital, Third Military Medical University
Chongqing, Chongqing Municipality, 400037
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
The first affiliated hospital,zhejiang university
Hangzhou, Zhejiang
Shandong Province Tumor Hospital
Jinan, Shandong, 250117
Chest hospital affiliated to Shanghai jiaotong university
Shanghai, Shanghai Municipality, 200000
Shanghai Changhai Hospital
Shanghai, Shanghai Municipality, 200433
The First Affiliated Hospital of Suzhou University
Suzhou, Jiangsu, 215006
Tianjin Medical University Cancer Hospital
Tianjin, Tianjin Municipality, 300060
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase II Study of Anlotinib(AL3818) as Third Line Treatment in Patients With Advanced Non-small Cell Lung Cancer（ALTER0302）
Anlotibib (AL3818) is a kind of innovative medicines approved by State Food and Drug Administration（SFDA:2011L00661） which was researched by Jiangsu Chia-tai Tianqing Pharmaceutical Co., Ltd. Anlotinib is a kinase inhibitor of receptor tyrosine with multi-targets, especially for VEGFR2、VEGFR3、PDGFRβ and c-Kit. It has the obvious resistance to new angiogenesis. The trial is to explore Anlotinib for the effectiveness and safety of andvanced non-small cell lung cancer who failed two lines of chemotherapy
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Anlotinib, Placebo capsule
- Keywords
- lung, Anlotinib, AL3818, NSCLC, Cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnlotinibDrug
Anlotinib QD po.
Placebo capsuleDrug
Placebo QD po.
| Study group | Role | What they receive |
|---|---|---|
| Anlotinib | Active comparator | Anlotinib QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent Receives: Drug: Anlotinib |
| Placebo Capsule | Placebo comparator | Placebo capsule QD po and it should be continued until disease progression or patients withdrawal of consent Receives: Drug: Placebo capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
enhanced CT/MRI scan
To evaluate the effectiveness of Anlotinib Hydrochloric Capsule by enhanced CT/MRI scan every two cycles. Refer to recist 1.1.
Measured: each 42 days up to disease progression
Secondary outcomes (1)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
contain Serious Adverse Event To evaluate the safety of Anlotinib by CTC AE 4.0
Measured: each 21 days up to intolerance the toxicity(or PD)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionMar 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bao hui Han, doctor, Principal investigator, Chest hospital affiliated to Shanghai jiaotong university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01924195
- Sponsor's protocol ID
- ALTN-03-II
- Status last verified
- Oct 2015
- First submitted
- 12 Aug 2013
- Last updated
- 28 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase II Study of Anlotinib(AL3818) as Third Line Treatment in Patients With Advanced Non-small Cell Lung Cancer（ALTER0302）
- ClinicalTrials.gov ID
- NCT01924195
- Acronym / sponsor ID
- ALTN-03-II
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- lung, Anlotinib, AL3818, NSCLC, Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 16 Aug 2013 (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.
Anlotibib (AL3818) is a kind of innovative medicines approved by State Food and Drug Administration（SFDA:2011L00661） which was researched by Jiangsu Chia-tai Tianqing Pharmaceutical Co., Ltd. Anlotinib is a kinase inhibitor of receptor tyrosine with multi-targets, especially for VEGFR2、VEGFR3、PDGFRβ and c-Kit. It has the obvious resistance to new angiogenesis. The trial is to explore Anlotinib for the effectiveness and safety of andvanced non-small cell lung cancer who failed two lines of chemotherapy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anlotinib | Active comparator | Drug: AnlotinibAnlotinib QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent |
| Placebo Capsule | Placebo comparator | Drug: Placebo capsulePlacebo capsule QD po and it should be continued until disease progression or patients withdrawal of consent |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- pathology diagnosed with advanced NSCL with measurable lesions;
- Have failed for 2 lines of chemotherapy;
- 18-70years,ECOG PS:0-2,Life expectancy of more than 3 months;
- Other cytotoxic drugs,radiation therapy,or surgery≥4 weeks;
- main organs function is normal;
Key exclusion criteria (10 listed)
- SCLC(including mixed with NSCLC);
- the central cavity of Squamous cell carcinoma and hemoptysis with NSCLC;
- patients failed to use the anti-tumor angiogenesis therapy;
- patients has many influence factors toward oral medications ;
- Brain metastases patients accompanied by symptoms or symptom control for less than two months;
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 QD po. | Drug | Anlotinib |
| Placebo capsulePlacebo QD po. | Drug | Placebo Capsule |
Primary outcome
enhanced CT/MRI scan
Time frame: each 42 days up to disease progression
To evaluate the effectiveness of Anlotinib Hydrochloric Capsule by enhanced CT/MRI scan every two cycles. Refer to recist 1.1.
1 secondary outcome
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: each 21 days up to intolerance the toxicity(or PD)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2015.
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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.
Bao hui Han, doctor principal investigator
Chest hospital affiliated to Shanghai jiaotong university
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 Anlotinib in people with Non-small Cell Lung Cancer, run by Chia Tai Tianqing Pharmaceutical Group 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 6 inclusion and 10 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: finished, as of the sponsor's last update on 28 Oct 2015. 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. 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
enhanced CT/MRI scan (time frame: each 42 days up to disease progression). 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 28 Oct 2015.