CancerPhase 2ALTN/STSNCT01878448
A Phase II Study of Anlotinib in STS Patients
A Phase 2 study testing Anlotinib in people with Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 16 sites in China.
Trial summary
Anlotibib (ALTN) is a kind of innovative medicines approved by State Food and Drug Administration（SFDA） which was researched by Jiangsu Chia-tai Tianqing Pharmaceutical Co., Ltd. ALTN is a kinase inhibitor of receptor tyrosine with multi-targets, especially for VEGFR2 and VEGFR3. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cancer
- What is being tested?
- Anlotinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 16 sitesChina
- Study dates
- Apr 2013to 30 Apr 2017
- 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
- 1.Faild in introditional treatmeat, Mainly includes:MFH/liposarcoma/leiomyosarcoma/SS and others(MPNST/Fibrosarcoma/CCS/ASPS/AS/ES; 2.Receiveed at least one chemotherapy regimens treatment; 3.18-70years, ECOG:0-2,Expected survival period >3 months; 4.HB≥100g/L,ANC(Absolute Neutrophil Count) ≥1.5×109/L；PLT
- 80×109/L ,BIL/Cr in normal range,ALT/AST(aspartate aminotransferase )≤1.5*ULN(for hepatic metastases,ALT/AST(aspartate aminotransferase )≤5*ULN) ;TG≤ 3.0mmol/L，cholesterol≤7.75mmol/L; LVEF
- LLN. 5.Used contraceptive during the study and after 6 months; 6.Volunteer.
Who cannot join
- 1. Received vascular endothelial growth inhibitor type of targeted therapy; 2.With the second cancer; 3.Participated in other clinical trials in four weeks; 4.Received in other radiotherapy or chemotherapy treatment in four weeks; 5.AE>1 6.Has influence of oral drugs; 7.Brain metastases, spinal cord compression, cancerous meningitis; 8.Any serious or failed to control the disease 9.Artery/venous thrombotic; 10.Coagulant function abnormality; 11.Arteriovenous thrombosis event; 12.Hitory of psychiatric drugs abuse or a mental disorder; 13.Immunodeficiency history; 14.Concomitant diseases.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
China16 sites
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100039
Beijing Cancer Hospital
Beijing, Beijing Municipality
Beijing Jishuitan Hospital
Beijing, Beijing Municipality
Peking Union Medical College Hospital
Beijing, Beijing Municipality
The 1st affiliated hospital of bengbu medical college
Bengbu, An'hui
Fujian Province Cancer Hospital
Fuzhou, Fujian
The First Affiliated Hospital of Fujian Meidical University
Fuzhou, Fujian
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong
Harbin medical university affiliated tumor hospital
Harbin, Heilongjiang
Gansu Province Tumor Hospital
Lanzhou, Gansu
Guangxi medical university affiliated tumor hospital
Nanning, Guangxi
Cancer Hospital of Fudan University
Shanghai, Shanghai Municipality
Shanghai 6th People's Hospital
Shanghai, Shanghai Municipality
Liaoning Province Tumor Hospital
Shenyang, Liaoning
Tianjin Medical University Cancer Hospital
Tianjin, Tianjin Municipality
About this study
Official title: Phase 2 Study of Anlotinib in Advanced Soft Tissue Sarcoma
Anlotibib (ALTN) is a kind of innovative medicines approved by State Food and Drug Administration（SFDA） which was researched by Jiangsu Chia-tai Tianqing Pharmaceutical Co., Ltd.
ALTN is a kinase inhibitor of receptor tyrosine with multi-targets, especially for VEGFR2 and VEGFR3. It has the obvious resistance to new angiogenesis. The protocol is to explore ALTN for the effectiveness of advanced soft tissue sarcoma and security.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnlotinibDrug
| Study group | Role | What they receive |
|---|---|---|
| Anlotinib | Experimental | Not described Receives: Drug: Anlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
tumor size
To evaluate the effectiveness of Anlotinib Hydrochloric Capsule by enhanced CT scan every two cycles. Refer to recist 1.1.
Measured: each 42 days up to 48 months
Secondary outcomes (1)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
blood examination, urine examination, stool examination, blood biochemical (ALT, AST, TB(total bilirubin), DB, BUN, Cr, blood electrolyte), electrocardiogram (ecg), thyroid function, the function of blood coagulation, etc
Measured: each 21 days up to 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2013 (estimated)
- Study startApr 2013
- Primary completionOct 2015
- Study completion30 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 166 participants (actual)
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
- NCT01878448
- Sponsor's protocol ID
- ALTN-02-II
- Acronym
- ALTN/STS
- Status last verified
- May 2019
- First submitted
- 30 May 2013
- Last updated
- 22 May 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of Anlotinib in Advanced Soft Tissue Sarcoma
- ClinicalTrials.gov ID
- NCT01878448
- Acronym / sponsor ID
- ALTN/STS / ALTN-02-II
- Conditions
- Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Oct 2015 (actual)
- Study completion
- 30 Apr 2017 (actual)
- First posted
- 17 Jun 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 (ALTN) is a kind of innovative medicines approved by State Food and Drug Administration（SFDA） which was researched by Jiangsu Chia-tai Tianqing Pharmaceutical Co., Ltd.
ALTN is a kinase inhibitor of receptor tyrosine with multi-targets, especially for VEGFR2 and VEGFR3. It has the obvious resistance to new angiogenesis. The protocol is to explore ALTN for the effectiveness of advanced soft tissue sarcoma and security.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anlotinib | Experimental | Drug: Anlotinib |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 1.Faild in introditional treatmeat, Mainly includes:MFH/liposarcoma/leiomyosarcoma/SS and others(MPNST/Fibrosarcoma/CCS/ASPS/AS/ES; 2.Receiveed at least one chemotherapy regimens treatment; 3.18-70years, ECOG:0-2,Expected survival period >3 months; 4.HB≥100g/L,ANC(Absolute Neutrophil Count) ≥1.5×109/L；PLT
Key exclusion criteria (1 listed)
- 1. Received vascular endothelial growth inhibitor type of targeted therapy; 2.With the second cancer; 3.Participated in other clinical trials in four weeks; 4.Received in other radiotherapy or chemotherapy treatment in four weeks; 5.AE>1 6.Has influence of oral drugs; 7.Brain metastases, spinal cord compression, cancerous meningitis; 8.Any serious or failed to control the disease 9.Artery/venous thrombotic; 10.Coagulant function abnormality; 11.Arteriovenous thrombosis event; 12.Hitory of psychiatric drugs abuse or a mental disorder; 13.Immunodeficiency history; 14.Concomitant diseases.
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 | Drug | Anlotinib |
Primary outcome
tumor size
Time frame: each 42 days up to 48 months
To evaluate the effectiveness of Anlotinib Hydrochloric Capsule by enhanced CT 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 48 months
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 22 May 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
16 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 Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 16 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 3 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: finished, as of the sponsor's last update on 22 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 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 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?
tumor size (time frame: each 42 days up to 48 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 22 May 2019.