Osteosarcoma, AdvancedPhase 2NCT03163381
Apatinib Second Line Treatment for Advanced Osteosarcoma and Soft Tissue Sarcomas ,Openting ,Single Center, One-armed Clinical Study.
A Phase 2 study testing Apatinib in people with Osteosarcoma, Advanced, run by Henan Cancer Hospital at 1 site in China.
Trial summary
Apatinib second line treatment for Advanced osteosarcoma and soft tissue sarcomas ,openting ,single center, one-armed clinical study. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Osteosarcoma, Advanced
- What is being tested?
- Apatinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 11 Apr 2017to 11 Apr 2019
- 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
- Subject joined the study of his or her own free will , signed informed consent;
- Subject that diagnosed with advanced osteosarcoma by pathology and first-line treatment failure, at least have one measurable lesion ; Or confirmed by the pathology of advanced soft tissue sarcomas, at least have one measurable lesion,main include Synovial sarcoma、 Leiomyosarcoma、Alveolar soft part sarcoma、Undifferentiated pleomorphic sarcoma/malignant fibrous histiocytoma、Adipocytic Tumors、 Fibrosarcoma、Clear cell sarcoma、Epithelioid sarcoma、Malignant peripheral nerve sheath tumor、Undifferentiatedsarcoma、 Rhabdomyosarcoma、chondrosarcoma、Osteosarcoma、Dermato- fibrosarcoma protuberans、GIST、Primitiveneuroectodermal tumor、Inflammatory myofibroblastic tumor、Malignant mesothelioma; 3)Within the past 6 months, Subject using at least one chemotherapy regimens (including anthracycline-based) failured (except gland alveolar soft tissue sarcoma); 4)18 to 70 years (including 18 and 70 ), men and women there is no limited. 5)ECOG PS score: 0 ~ 1; 6)Estimated survival period more than 3 months; 7)Main organs function within 7 days before the treatment, meet the following criteria:
- Blood routine examination standard( without blood transfusion condition in 14 days) :HB≥90g/L;②ANC≥1.5×109/L;③PLT≥80×109/L
- Blood biochemical examination must meet the following criteria:
- ① TBIL≤1.5ULN ;②ALT and AST≤2.5ULN,if With hepatic metastatic carcinoma,ALT and AST≤5ULN;③Cr≤1.5ULN或CCr≥60ml/min;
- Doppler ultrasound assessment: LVEF normal or low limit (50%).
Who cannot join
- 1)Subject with hypertension, and after antihypertensive drug therapy can't to the normal range (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg), Ⅱ or higher level of coronary heart disease, arrhythmia (include QTc prolonging, male > 450 ms, female > 470 ms) and cardiac insufficiency; 2)Subject used targeted therapy of vascular endothelial growth inhibitor drug previous, include Sunitinib, Sorafenib ,bevacizumab, imatinib and so on.
- 3)With other malignant tumor before or at the same time, but except the cured skin basal cell carcinoma and carcinoma in situ of cervix.
- 4)Subject accepted anticancer therapy before with NCI CTCAE classification > 1 grade toxicity reaction.
- 5)Has multi-factors that effect of oral drug absorption(, such as unable to swallow, nausea or vomiting, chronic diarrhea and intestinal obstruction, etc.); 6)Special note: subject with gastrointestinal bleeding risk can't enrolled the study, include: (1) there are active peptic ulcer lesions, and defecate occult blood (+ +);(2)Subject with medical history include Melena、hematemesis in three months;(3) Subject must be of gastroscopy with defecate occult blood, clear whether deposit organic gastrointestinal tract diseases; 7)Subject with coagulant function abnormality (INR > 1.5 x ULN, APTT > 1.5 x ULN), bleeding tendency; 8)Didn't heal wounds for a long time or fracture. 9)Subject with active bleeding or within 30 days after Major surgery. 10)Intracranial metastasis; 11)Pregnant or lactating women; 12)cell toxic drug therapy, radiation therapy 3 weeks after treatment; Once took two or more targeted drugs, or once took other targeted drugs 3 months before enrollment.
- 13)Suffered from other malignant tumor for the past three years. 14)Investigator considered that there may be exist any situation that can damage subject or result in subject can't meet or carry out Investigator requests.
- 15)huge transfer/recurrent lesions(tumor size greater than 5 cm). 16)malignant pleuraleffusion or peritoneal effusion, caused NCI CTCAE grading more than 2 levels of breathing difficulties; Description: oversized tumor load often indicates poor blood supply, lead to drug unable to effectively into the tumor, in order to accurately assess the treatment effects apatinib to the soft tissue sarcomas, Our study do not accept with huge transfer recurrent focal (tumor diameter greater than 5 cm) of the patients into groups temporarily .
- 17)Allergy to any ingredient about apatinibshould be ruled out; 18)Subject with severe liver and renal failure (level 4) should be ruled out; 19)Subject has a history of psychiatric drugs abuse and can't quit or have a mental disorder; 20)According to the investigator's judgment, subject who has concomitant diseases that serious to endanger the safety or impact subject to complete the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Henan cancer hospital
Zhengzhou, Henan, 450000
Jing Ding, 0371-65588251
About this study
Apatinib second line treatment for Advanced osteosarcoma and soft tissue sarcomas ,openting ,single center, one-armed clinical study.
Read the detailed description
The treatment of bone and soft tissue sarcomas are usually surgery and chemotherapy,advanced cases cannot be removed through surgical method for multiple metastasis,advanced cases Most advanced cases with chemotherapy is given priority to, but the effect is not ideal.Apatinib main through inhibit VEGFR to give play to Anti-angiogenesis effect to treatment of malignant tumor.
- Conditions
- Osteosarcoma, Advanced
- Being tested
- Apatinib
- Keywords
- first-line treatment failure, one measurable lesion
- Medical subject headings
- Osteosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApatinibDrug
Apatinib 500mg,po,qd,medicine to disease progression.
| Study group | Role | What they receive |
|---|---|---|
| Apatinib | Experimental | Apatinib 500mg/d from day 1 to day 28, repeated every 28 days until progressive Disease(PD) . Receives: Drug: Apatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
progress free survival
time from study drug treatment to tumor progress
Measured: 6 months
Secondary outcomes (1)
overall survival
Time from study drug treatment to die
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 posted23 May 2017
- Study start11 Apr 2017
- Primary completion11 Oct 2017 (estimated)
- Study completion11 Apr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteosarcoma, AdvancedStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Responsible party
- Principal investigator, YaoWeitao, Henan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03163381
- Sponsor's protocol ID
- AHEAD-HNP007
- Status last verified
- May 2017
- First submitted
- 18 May 2017
- Last updated
- 23 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Temporarily not sure whether to be Shared the data.
Publications
Hattinger CM, Patrizio MP, Magagnoli F, Luppi S, Serra M. An update on emerging drugs in osteosarcoma: towards tailored therapies? Expert Opin Emerg Drugs. 2019 Sep;24(3):153-171. doi: 10.1080/14728214.2019.1654455. Epub 2019 Aug 14.
PubMed 31401903
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Apatinib Second Line Treatment for Advanced Osteosarcoma and Soft Tissue Sarcomas ,Openting ,Single Center, One-armed Clinical Study.
- ClinicalTrials.gov ID
- NCT03163381
- Acronym / sponsor ID
- AHEAD-HNP007
- Conditions
- Osteosarcoma, Advanced
- Keywords
- first-line treatment failure, one measurable lesion
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Henan Cancer HospitalOther government
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Study start
- 11 Apr 2017 (actual)
- Primary completion
- 11 Oct 2017 (estimated)
- Study completion
- 11 Apr 2019 (estimated)
- First posted
- 23 May 2017 (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.
Apatinib second line treatment for Advanced osteosarcoma and soft tissue sarcomas ,openting ,single center, one-armed clinical study.
Detailed description
The treatment of bone and soft tissue sarcomas are usually surgery and chemotherapy,advanced cases cannot be removed through surgical method for multiple metastasis,advanced cases Most advanced cases with chemotherapy is given priority to, but the effect is not ideal.Apatinib main through inhibit VEGFR to give play to Anti-angiogenesis effect to treatment of malignant tumor.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Apatinib | Experimental | Drug: ApatinibApatinib 500mg/d from day 1 to day 28, repeated every 28 days until progressive Disease(PD) . |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject joined the study of his or her own free will , signed informed consent;
- Subject that diagnosed with advanced osteosarcoma by pathology and first-line treatment failure, at least have one measurable lesion ; Or confirmed by the pathology of advanced soft tissue sarcomas, at least have one measurable lesion,main include Synovial sarcoma、 Leiomyosarcoma、Alveolar soft part sarcoma、Undifferentiated pleomorphic sarcoma/malignant fibrous histiocytoma、Adipocytic Tumors、 Fibrosarcoma、Clear cell sarcoma、Epithelioid sarcoma、Malignant peripheral nerve sheath tumor、Undifferentiatedsarcoma、 Rhabdomyosarcoma、chondrosarcoma、Osteosarcoma、Dermato- fibrosarcoma protuberans、GIST、Primitiveneuroectodermal tumor、Inflammatory myofibroblastic tumor、Malignant mesothelioma; 3)Within the past 6 months, Subject using at least one chemotherapy regimens (including anthracycline-based) failured (except gland alveolar soft tissue sarcoma); 4)18 to 70 years (including 18 and 70 ), men and women there is no limited. 5)ECOG PS score: 0 ~ 1; 6)Estimated survival period more than 3 months; 7)Main organs function within 7 days before the treatment, meet the following criteria:
- ① TBIL≤1.5ULN ;②ALT and AST≤2.5ULN,if With hepatic metastatic carcinoma,ALT and AST≤5ULN;③Cr≤1.5ULN或CCr≥60ml/min;
Key exclusion criteria (7 listed)
- 3)With other malignant tumor before or at the same time, but except the cured skin basal cell carcinoma and carcinoma in situ of cervix.
- 4)Subject accepted anticancer therapy before with NCI CTCAE classification > 1 grade toxicity reaction.
- 5)Has multi-factors that effect of oral drug absorption(, such as unable to swallow, nausea or vomiting, chronic diarrhea and intestinal obstruction, etc.); 6)Special note: subject with gastrointestinal bleeding risk can't enrolled the study, include: (1) there are active peptic ulcer lesions, and defecate occult blood (+ +);(2)Subject with medical history include Melena、hematemesis in three months;(3) Subject must be of gastroscopy with defecate occult blood, clear whether deposit organic gastrointestinal tract diseases; 7)Subject with coagulant function abnormality (INR > 1.5 x ULN, APTT > 1.5 x ULN), bleeding tendency; 8)Didn't heal wounds for a long time or fracture. 9)Subject with active bleeding or within 30 days after Major surgery. 10)Intracranial metastasis; 11)Pregnant or lactating women; 12)cell toxic drug therapy, radiation therapy 3 weeks after treatment; Once took two or more targeted drugs, or once took other targeted drugs 3 months before enrollment.
- 13)Suffered from other malignant tumor for the past three years. 14)Investigator considered that there may be exist any situation that can damage subject or result in subject can't meet or carry out Investigator requests.
- 15)huge transfer/recurrent lesions(tumor size greater than 5 cm). 16)malignant pleuraleffusion or peritoneal effusion, caused NCI CTCAE grading more than 2 levels of breathing difficulties; Description: oversized tumor load often indicates poor blood supply, lead to drug unable to effectively into the tumor, in order to accurately assess the treatment effects apatinib to the soft tissue sarcomas, Our study do not accept with huge transfer recurrent focal (tumor diameter greater than 5 cm) of the patients into groups temporarily .
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 |
|---|---|---|
| ApatinibApatinib 500mg,po,qd,medicine to disease progression. | Drug | Apatinib |
Primary outcome
progress free survival
Time frame: 6 months
time from study drug treatment to tumor progress
1 secondary outcome
overall survival
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 23 May 2017.
- Derived from this study: PubMed 31401903Hattinger CM, Patrizio MP, Magagnoli F, Luppi S, Serra M. An update on emerging drugs in osteosarcoma: towards tailored therapies? Expert Opin Emerg Drugs. 2019 Sep;24(3):153-171. doi: 10.1080/14728214.2019.1654455. Epub 2019 Aug 14.
- Individual participant dataSharing planned: Undecided. Temporarily not sure whether to be Shared the data.
Related trials for Osteosarcoma, Advanced
Active, not recruitingPhase 2
Ensartinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With ALK or ROS1 Genomic Alterations (A Pediatric MATCH Treatment Trial)
Advanced Malignant Solid Neoplasm, Malignant Solid Neoplasm
RecruitingPhase 1
A Phase 1/1B Study of ST-01156, a Small Molecule RBM39 Degrader, in Patients With Advanced Solid Malignancies
Advanced Solid Tumors, Ewing Sarcoma
RecruitingPhase 1
A Phase I Study of XS-02 Capsules in Patients With Advanced Solid Tumors
Solid Tumor, Ovarian Cancer
Active, not recruitingPhase 2
Tipifarnib for the Treatment of Advanced Solid Tumors, Lymphoma, or Histiocytic Disorders With HRAS Gene Alterations, a Pediatric MATCH Treatment Trial
Malignant Solid Neoplasm, Recurrent Adrenal Gland Pheochromocytoma
Active, not recruitingPhase 2
Erdafitinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With FGFR Mutations (A Pediatric MATCH Treatment Trial)
Advanced Malignant Solid Neoplasm, Recurrent Childhood Ependymoma
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Apatinib in people with Osteosarcoma, Advanced, run by Henan Cancer Hospital at 1 site 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 23 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Weitao Yao (13298189535, ywtwhm@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progress free survival (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03163381, which also lists 1 linked publication.
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 23 May 2017.