Soft Tissue SarcomaPhase 2/3NCT02449343
Study of Anlotinib in Patients With Soft Tissue Sarcoma（STS）(ALTER0203)
A Phase 2/3 study testing Anlotinib in people with Soft Tissue Sarcoma, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 25 sites in China.
Trial summary
Compare the effects and safety of Anlotinib with placebo in patients with soft tissue sarcoma. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Soft Tissue Sarcoma
- What is being tested?
- Anlotinib
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 233 participants
- Where
- 25 sitesChina
- Study dates
- 12 May 2015to Apr 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed and dated informed consent
- Histological documentation of Soft Tissue Sarcoma,including Synovial sarcoma、Leiomyosarcoma、Alveolar soft part sarcoma、Undifferentiated pleomorphic sarcoma/malignant fibrous histiocytoma、Adipocytic Tumors、Fibrosarcoma、Clear cell sarcoma、Epithelioid sarcoma，With measurable disease.
- Within the past 6 months, using at least one failure of chemotherapy regimens (including anthracycline-based) in treating patients(except alveolar soft part sarcoma)
- 18-70years,ECOG PS:0-1,Life expectancy of more than 3 months
- Main organs function is normal
- The woman patients of childbearing age who must agree to take contraceptive methods (e.g. intrauterine device, contraceptive pill or condom) during the research and within another 6 months after it; who are not in the lactation period and examined as negative in blood serum test or urine pregnancy test within 7 days before the research; The man patients who must agree to take contraceptive methods during the research and within another 6 months after it
Who cannot join
- Prior treatment with Anlotinib
- With pleural effusion or ascites, cause respiratory syndrome
- Accepted the vascular endothelial growth inhibitor class targeted drug treatment of patients
- Plan to take systemic anti-tumor therapy within 4 weeks before grouping or during the medicine-taking period of this research, including Cytotoxic Therapy, Signal Transduction Inhibitor, and Immunotherapy (or who use Mitomycin C within 6 weeks before taking the treatment with experimental drug); The patients who have already taken Extended Field Radiotherapy (EF-RT) within 4 weeks before grouping or Limited Field Radiotherapy with proposed assessment of nidus within 2 weeks before grouping
- Symptoms of brain metastases cannot be controlled and treated within less than 2 months
- With severe and failed to controlled diseases
- Occurred venous thromboembolic events within 6 months
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
China25 sites
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Beijing Cancer Hospital
Beijing, Beijing Municipality
Peking Union Medical College Hospital
Beijing, Beijing Municipality
The 1st Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui
Hunan Province Tumor Hospital
Changsha, Hunan
West China Hospital , Sichuan University
Chengdu, Sichuan
The First Affiliated Hospital of Fujian Meidical University
Fuzhou, Fujian
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, 510000
The First Affiliated Hospital of Sun Yat-sen university
Guangzhou, Guangdong
Harbin medical university affiliated tumor hospital
Harbin, Heilongjiang
Gansu Cancer Hospital
Lanzhou, Gansu, 730050
Henan Province Tumor Hospital
Luoyan, Henan
Jiangxi Cancer Hospital
Nanchang, Jiangxi, 330029
Guangxi medical university affiliated tumor hospital
Nanning, Guangxi
Ruijin Hospital Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200025
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Fudan University Zhongshan Hospital
Shanghai, Shanghai Municipality, 200032
Shanghai General Hospital
Shanghai, Shanghai Municipality, 200080
Shanghai 6th People's Hospital
Shanghai, Shanghai Municipality
Liaoning Province Tumor Hospital
Shenyang, Liaoning
The Third Hospital of hebei Medical University
Shijiazhuang, Hebei, 050051
Tianjin Hospital
Tianjin, Tianjin Municipality, 300211
Tianjin Medical University Cancer Hospital
Tianjin, Tianjin Municipality
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, 430022
The First Affiliated Hospital of Xian Jiaotong University
Xian, Shanxi
About this study
Official title: A Registered Randomized, Double-Blind, Placebo-Controlled (2:1), Multi-Centered Clinical Trial of Anlotinib as a Treatment for Soft Tissue Sarcoma
Compare the effects and safety of Anlotinib with placebo in patients with soft tissue sarcoma.
- Conditions
- Soft Tissue Sarcoma
- Being tested
- Anlotinib, Placebo
- Medical subject headings
- Sarcoma
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.
Progress free survival (PFS)
Measured: up to 24 months
Secondary outcomes (3)
Overall Survival (OS)
Measured: up to 24 months
Objective Response Rate (ORR)
Measured: up to 24 months
Disease Control Rate (DCR)
Measured: 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 posted20 May 2015 (estimated)
- Study start12 May 2015
- Primary completionApr 2017 (estimated)
- Study completionApr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Tissue SarcomaStudies 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
- 233 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
- NCT02449343
- Sponsor's protocol ID
- ALTN-02-IIB
- Status last verified
- Apr 2017
- First submitted
- 17 May 2015
- Last updated
- 25 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Registered Randomized, Double-Blind, Placebo-Controlled (2:1), Multi-Centered Clinical Trial of Anlotinib as a Treatment for Soft Tissue Sarcoma
- ClinicalTrials.gov ID
- NCT02449343
- Acronym / sponsor ID
- ALTN-02-IIB
- Conditions
- Soft Tissue Sarcoma
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 233 participants (actual)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 May 2015 (actual)
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Apr 2017 (estimated)
- First posted
- 20 May 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.
Compare the effects and safety of Anlotinib with placebo in patients with soft tissue sarcoma.
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 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Signed and dated informed consent
- Histological documentation of Soft Tissue Sarcoma,including Synovial sarcoma、Leiomyosarcoma、Alveolar soft part sarcoma、Undifferentiated pleomorphic sarcoma/malignant fibrous histiocytoma、Adipocytic Tumors、Fibrosarcoma、Clear cell sarcoma、Epithelioid sarcoma，With measurable disease.
- Within the past 6 months, using at least one failure of chemotherapy regimens (including anthracycline-based) in treating patients(except alveolar soft part sarcoma)
- 18-70years,ECOG PS:0-1,Life expectancy of more than 3 months
- Main organs function is normal
Key exclusion criteria (7 listed)
- Prior treatment with Anlotinib
- With pleural effusion or ascites, cause respiratory syndrome
- Accepted the vascular endothelial growth inhibitor class targeted drug treatment of patients
- Plan to take systemic anti-tumor therapy within 4 weeks before grouping or during the medicine-taking period of this research, including Cytotoxic Therapy, Signal Transduction Inhibitor, and Immunotherapy (or who use Mitomycin C within 6 weeks before taking the treatment with experimental drug); The patients who have already taken Extended Field Radiotherapy (EF-RT) within 4 weeks before grouping or Limited Field Radiotherapy with proposed assessment of nidus within 2 weeks before grouping
- Symptoms of brain metastases cannot be controlled and treated within less than 2 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 p.o. qd | Drug | Anlotinib |
| PlaceboPlacebo p.o. qd | Drug | Placebo |
Primary outcome
Progress free survival (PFS)
Time frame: up to 24 months
3 secondary outcomes
Overall Survival (OS)
Time frame: up to 24 months
Objective Response Rate (ORR)
Time frame: up to 24 months
Disease Control Rate (DCR)
Time frame: 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 25 Apr 2017.
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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.
25 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 Soft Tissue Sarcoma, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 25 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 7 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 25 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 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?
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?
Progress free survival (PFS) (time frame: 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 25 Apr 2017.