EfficacyNCT03491371
Apatinib for Advanced Sarcoma: Results From Multiple Institutions' Off-label Use
A study testing Methylsulfonic apatinib in people with Efficacy and Toxicity, run by Peking University People's Hospital at 2 sites in China.
Trial summary
Anti-angiogenesis Tyrosine kinase inhibitors (TKIs) have been proved to show promising effects on prolonging progression-free survival (PFS) for advanced sarcoma after failure of standard multimodal Therapy. Methylsulfonic apatinib is one of those TKIs which specifically inhibits VEGFR-2. Read more about this study
- Who is it for?
- Any age
- What is being tested?
- Methylsulfonic apatinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jun 2015to 1 Feb 2017
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 1) histologically confirmed high-grade sarcoma;
- 2) initial treatment in the orthopedic oncology departments of the three affiliated hospitals of Peking University;
- 3) tumors not amenable to curative treatment or inclusion in clinical trials;
- 4) unresectable local advanced lesions or multiple metastatic lesions that could not be cured by local therapy;
- 5) measurable lesions according to Response Evaluation Criteria for Solid Tumors (RECIST1.1) [8];
- 6) Eastern Cooperative Oncology Group performance status 0 or 1 [9]; and 7) acceptable hematologic, hepatic, and renal function.
Who cannot join
- had been previously exposed to other TKIs;
- had central nervous system metastasis;
- had other kinds of malignant tumors at the same time; had cardiac insufficiency or arrhythmia;
- had uncontrolled complications such as diabetes mellitus, coagulation disorders, urine protein ≥ ++ and so on;
- had pleural or peritoneal effusion that needs to be handled by surgical treatment;
- combined with other infections or wounds
- were pregnant or breastfeeding.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Musculoskeletal Tumor Center of Peking University People's Hospital
Beijing, 100044
Peking University Shougang Hospital
Beijing, 100144
About this study
Official title: The Effectivity and Toxicity of Methylsulfonic Apatinib for Extensively Pre-treated Advanced Sarcoma: a Multicentric Retrospective Study in China
Anti-angiogenesis Tyrosine kinase inhibitors (TKIs) have been proved to show promising effects on prolonging progression-free survival (PFS) for advanced sarcoma after failure of standard multimodal Therapy. Methylsulfonic apatinib is one of those TKIs which specifically inhibits VEGFR-2. This study summarizes the experience of three Peking University affiliated hospitals in off-label use of apatinib in the treatment of extensively pre-treated sarcoma.
Read the detailed description
The investigators retrospectively analysed files of patients with advanced sarcoma not amenable to curative treatment, who were receiving an apatinib-containing regimen between June 1, 2015 and December 1, 2016. Fifty-six patients were included: 22 osteosarcoma, 10 Ewing's sarcoma, 3 chondrosarcoma and 21 soft tissue sarcoma.
- Being tested
- Methylsulfonic apatinib
- Keywords
- apatinib, tyrosine-kinase inhibitors, osteosarcoma, Ewing sarcoma, chondrosarcoma, soft-tissue sarcoma
- Medical subject headings
- Osteosarcoma, Sarcoma, Ewing, Chondrosarcoma, Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methylsulfonic apatinibDrug
Anti-angiogenesis Tyrosine kinase inhibitor which specifically inhibits VEGFR-2.
| Study group | Role | What they receive |
|---|---|---|
| osteosarcoma | Experimental | all patients had been given apatinib alone Receives: Drug: Methylsulfonic apatinib |
| Ewing sarcoma | Experimental | Some of patients had been given apatinib alone while some of them had been given apatinib+everolimus Receives: Drug: Methylsulfonic apatinib |
| soft tissue sarcoma | Experimental | Some of the patients had been given apatinib alone while some of the patients had been given apatinib together with GT chemotherapy, which was gemcitabine 1000 mg/m2 d1,8 and docetaxel 75 mg/m2 d8 once every 21 day. Receives: Drug: Methylsulfonic apatinib |
| Chondrosarcoma | Experimental | Patients were given apatinib alone Receives: Drug: Methylsulfonic apatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
objective response rate
CR+PR accroding to RECIST 1.1
Measured: 3 month
Secondary outcomes (4)
progression-free survival, PFS
PFS was defined as time from the start of using apatinib until disease progression or death, whichever occurred first.
Measured: 4 months and 6 months
duration of response, DOR
The time from appearance of response or stable disease to progression or death was thus considered the DOR
Measured: 4 months
Overall Survival,OS
OS was defined as time from the start of using apatinib until death.
Measured: 12 months
toxicity
accroding to the Common Terminology Criteria for Adverse Events 4.0
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2018
- Study start1 Jun 2015
- Primary completion31 Dec 2016
- Study completion1 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EfficacyStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University Shougang Hospital, Peking University International Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03491371
- Sponsor's protocol ID
- PKUPH-sarcoma 01
- Status last verified
- Apr 2018
- First submitted
- 31 Mar 2018
- Last updated
- 10 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectivity and Toxicity of Methylsulfonic Apatinib for Extensively Pre-treated Advanced Sarcoma: a Multicentric Retrospective Study in China
- ClinicalTrials.gov ID
- NCT03491371
- Acronym / sponsor ID
- PKUPH-sarcoma 01
- Keywords
- apatinib, tyrosine-kinase inhibitors, osteosarcoma, Ewing sarcoma, chondrosarcoma, soft-tissue sarcoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Collaborators
- Peking University Shougang Hospital, Peking University International Hospital
- Study start
- 1 Jun 2015 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 1 Feb 2017 (actual)
- First posted
- 9 Apr 2018 (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.
Anti-angiogenesis Tyrosine kinase inhibitors (TKIs) have been proved to show promising effects on prolonging progression-free survival (PFS) for advanced sarcoma after failure of standard multimodal Therapy. Methylsulfonic apatinib is one of those TKIs which specifically inhibits VEGFR-2. This study summarizes the experience of three Peking University affiliated hospitals in off-label use of apatinib in the treatment of extensively pre-treated sarcoma.
Detailed description
The investigators retrospectively analysed files of patients with advanced sarcoma not amenable to curative treatment, who were receiving an apatinib-containing regimen between June 1, 2015 and December 1, 2016. Fifty-six patients were included: 22 osteosarcoma, 10 Ewing's sarcoma, 3 chondrosarcoma and 21 soft tissue sarcoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| osteosarcoma | Experimental | Drug: Methylsulfonic apatiniball patients had been given apatinib alone |
| Ewing sarcoma | Experimental | Drug: Methylsulfonic apatinibSome of patients had been given apatinib alone while some of them had been given apatinib+everolimus |
| soft tissue sarcoma | Experimental | Drug: Methylsulfonic apatinibSome of the patients had been given apatinib alone while some of the patients had been given apatinib together with GT chemotherapy, which was gemcitabine 1000 mg/m2 d1,8 and docetaxel 75 mg/m2 d8 once every 21 day. |
| Chondrosarcoma | Experimental | Drug: Methylsulfonic apatinibPatients were given apatinib alone |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 1) histologically confirmed high-grade sarcoma;
- 2) initial treatment in the orthopedic oncology departments of the three affiliated hospitals of Peking University;
- 3) tumors not amenable to curative treatment or inclusion in clinical trials;
- 4) unresectable local advanced lesions or multiple metastatic lesions that could not be cured by local therapy;
- 5) measurable lesions according to Response Evaluation Criteria for Solid Tumors (RECIST1.1) [8];
Key exclusion criteria (7 listed)
- had been previously exposed to other TKIs;
- had central nervous system metastasis;
- had other kinds of malignant tumors at the same time; had cardiac insufficiency or arrhythmia;
- had uncontrolled complications such as diabetes mellitus, coagulation disorders, urine protein ≥ ++ and so on;
- had pleural or peritoneal effusion that needs to be handled by surgical treatment;
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 |
|---|---|---|
| Methylsulfonic apatinibAnti-angiogenesis Tyrosine kinase inhibitor which specifically inhibits VEGFR-2. | Drug | Chondrosarcoma, Ewing sarcoma, osteosarcoma, soft tissue sarcoma |
Primary outcome
objective response rate
Time frame: 3 month
CR+PR accroding to RECIST 1.1
4 secondary outcomes
progression-free survival, PFS
Time frame: 4 months and 6 months
duration of response, DOR
Time frame: 4 months
Overall Survival,OS
Time frame: 12 months
toxicity
Time frame: 12 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 10 Apr 2018.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Methylsulfonic apatinib in people with Efficacy and Toxicity, run by Peking University People's Hospital at 2 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: finished, as of the sponsor's last update on 10 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
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?
objective response rate (time frame: 3 month). 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 10 Apr 2018; AzTrials last refreshed its copy on 31 Oct 2026.