OsteosarcomaPhase 2/3NCT02711007
Apatinib for Advanced Osteosarcoma After Failure of Standard Multimodal Therapy
A Phase 2/3 study testing apatinib in people with Osteosarcoma and Metastasis, run by GUO WEI at 1 site in China.
Trial summary
After standard multimodal therapy, the prognosis of relapsed and unresectable high-grade osteosarcoma is dismal and unchanged over the last decades.Thus, the investigators explored apatinib activity in patients with relapsed and unresectable osteosarcoma after the failure of first-line or second-line chemotherapy. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Osteosarcoma, Metastasis
- What is being tested?
- apatinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteChina
- Study dates
- Mar 2016to 8 Jan 2018
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- age >16 years;
- diagnosis confirmed histologically and reviewed centrally;
- prior treatment (completed >4 weeks before trial entry) consisted of standard high-grade osteosarcoma chemotherapy agents including doxorubicin, cisplatin, high- dose methotrexate, and ifosfamide; metastatic relapsed and unresectable progressive disease (PD);
- Eastern Cooperative Oncology Group performance status 0-1 with a life expectancy >3 months;
- adequate renal, hepatic, and hemopoietic function;
- normal or controlled blood pressure;
- surgery and/or radiotherapy completion at least 1 month before enrollment.
Who cannot join
- no pulmonary artery or venous tumor embolus;
- previously exposed to other TKIs;
- central nervous system metastasis;
- have had other kinds of malignant tumors at the same time;
- cardiac insufficiency or arrhythmia;
- uncontrolled complications, such as diabetes mellitus and so on;
Show all 10Show fewer
- coagulation disorders;
- urine protein≥ ++;
- pleural or peritoneal effusion that needs to be handled by surgical treatment;
- combined with other infections or wounds.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
About this study
Official title: A Phase II Trial of Apatinib in Relapsed and Unresectable High-grade Osteosarcoma After Failure of Standard Multimodal Therapy
After standard multimodal therapy, the prognosis of relapsed and unresectable high-grade osteosarcoma is dismal and unchanged over the last decades.Thus, the investigators explored apatinib activity in patients with relapsed and unresectable osteosarcoma after the failure of first-line or second-line chemotherapy. Patients >16 years, progressing after standard treatment, were eligible to receive 500 mg or 750 mg of apatinib once daily until progression or unacceptable toxicity. The primary end point was progression-free survival (PFS) at 4 months and objective response rate (ORR). Secondary objectives were PFS, overall survival (OS), clinical benefit rate (CBR), defined as no progression at 6 months and safety.
Read the detailed description
Patients
Eligible patients should have the following characteristics: age >16 years; diagnosis of high-grade osteosarcoma confirmed histologically and reviewed centrally; prior treatment (completed >4 weeks before trial entry) consisted of standard high-grade osteosarcoma chemotherapy agents including doxorubicin, cisplatin, high-dose methotrexate, and ifosfamide; metastatic relapsed and unresectable progressive disease (PD); Eastern Cooperative Oncology Group performance status 0-1 with a life expectancy >3 months; adequate renal, hepatic, and hemopoietic function. Additionally, the investigators require normal or controlled blood pressure, as well as surgery and/or radiotherapy completion at least 1 month before enrollment. All enrolled patients showed radiological evidence of disease progression and the lesion could be evaluated according to RECIST 1.1 before treatment start.
Treatment
Patients are planned to be treated with a dose of apatinib 500 mg(BSA ≤1.5) or 750mg(BSA>1.5) once daily. The dose was reduced or temporarily suspended according to predefined rules and after considering any observed toxicity, which was assessed according to the Common Terminology Criteria for Adverse Events version 3.0. Following adverse event resolution, apatinib can be restarted at the maximally tolerated dose and continued until progression, unacceptable toxicity or patient refusal. The study was approved by participating hospital review boards, and conducted according to the Declaration of Helsinki and the International Conference on Harmonization of Good Clinical Practice guidelines. Each patient provided written informed consent.
Efficacy Assessment
Before starting treatment, patients should be staged with chest and abdomen computed tomography (CT) and magnetic resonance imaging (MRI) (whenever indicated by the clinical situation). And all those patients should be tested by Immunohistochemistry of the VEGFR-2 over-expression of the paraffin embedded samples of the lesion or mRNA testing VEGFR-2 over-expression of the fresh specimen. Baseline assessment included also full blood count, serum chemistry, electrocardiogram and physical examination. In light of its potential role in osteosarcoma response assessment, [18F]2-fluoro-2-deoxy-D-glucose-positron emission tomography (FDG-PET) is suggested but not mandated for patient enrollment, and its impact on tumor response assessment was purely exploratory. All tests were repeated after 2 months and, thereafter, at 2-month intervals unless there were toxic effects or disease progression suspicion. Response was assessed by CT/MRI scan according to RECIST 1.1. Thus, both complete and partial remission needed confirmation within 4 weeks of when a response was first demonstrated. Stable disease (SD) was confirmed after a minimum of 8 weeks. The investigators thoroughly probe for and record any sign(s) of treatment-induced improvement, be it minor response (MR) as tumor shrinkage <30%, and/or nondimensional tumor responses including Hounsfield unit measured tissue density changes or osteoid matrix calcification.
The primary end point progression-free survival (PFS) at 4 months is calculated from the date of treatment start until the time of disease progression or death, whichever came first. Patients alive and free from progression would be censored. Secondary end points included the following: PFS; OS; overall response rate, defined as complete responses (CRs) + partial responses (PRs) + MRs; disease control rate (overall response rate + SDs); patterns of nondimensional response; clinical benefit rate (CBR) (PFS rate at 4 months) and duration of response. Duration of response is calculated from the day of first response assessment until either progression/death (event) or last day of follow-up (censored). Last, the investigators evaluate any clinical improvement by means of the Pain Analgesic Score via the Brief Pain Inventory (BPI) score form that was filled in by patients themselves. Analgesic medication use was recorded according to the analgesic score: 0 = none; 1 = minor analgesics; 2 = tranquillizers, antidepressants, muscle relaxants and steroids; 3 = mild narcotics; 4 = strong narcotics.
- Conditions
- Osteosarcoma, Metastasis
- Being tested
- apatinib
- Keywords
- osteosarcoma, metastasis, advanced, apatinib
- Medical subject headings
- Osteosarcoma, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
apatinibDrug
Apatinib is a small-molecule VEGFR tyrosine kinase inhibitor, similar to vatalanib (PTK787), but with a binding affinity 10 times that of vatalanib or sorafenib.
| Study group | Role | What they receive |
|---|---|---|
| apatinib | Experimental | apatinib 750mg tablet or 500mg tablet by mouth, Qd half an hour after dinner Receives: Drug: apatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival, PFS
calculated from the date of treatment start until the time of disease progression or death, whichever comes first.
Measured: 4 months
Objective response rate, ORR
CR+PR at 3 months
Measured: 3 months
Secondary outcomes (3)
Overall survival, OS
calculated from the date of treatment start until last follow-up or death, whichever comes first.
Measured: 12 months
Clinical benefit rate, CBR
CR+PR+SD at 6 months
Measured: 6 months
Duration of response, DOR
Duration of response is calculated from the day of first response assessment until either progression/death (event) or last day of follow-up (censored).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2016 (estimated)
- Study startMar 2016
- Primary completion30 Dec 2017
- Study completion8 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for OsteosarcomaStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- GUO WEI
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, GUO WEI, Peking University People's Hospital
- Investigators
- Wei Guo, M.D. Ph.D., Study chair, Chinese Medical Association--Sarcoma group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02711007
- Sponsor's protocol ID
- PKUPH-sarcoma
- Status last verified
- Apr 2018
- First submitted
- 13 Mar 2016
- Last updated
- 23 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: the investigator decide to share all the statistical analysis plan, clinical study report and anlytic code to other researchers
Publications
Bernthal NM, Federman N, Eilber FR, Nelson SD, Eckardt JJ, Eilber FC, Tap WD. Long-term results (>25 years) of a randomized, prospective clinical trial evaluating chemotherapy in patients with high-grade, operable osteosarcoma. Cancer. 2012 Dec 1;118(23):5888-93. doi: 10.1002/cncr.27651. Epub 2012 May 30.
PubMed 22648705Bielack S, Jurgens H, Jundt G, Kevric M, Kuhne T, Reichardt P, Zoubek A, Werner M, Winkelmann W, Kotz R. Osteosarcoma: the COSS experience. Cancer Treat Res. 2009;152:289-308. doi: 10.1007/978-1-4419-0284-9_15.
PubMed 20213397Kempf-Bielack B, Bielack SS, Jurgens H, Branscheid D, Berdel WE, Exner GU, Gobel U, Helmke K, Jundt G, Kabisch H, Kevric M, Klingebiel T, Kotz R, Maas R, Schwarz R, Semik M, Treuner J, Zoubek A, Winkler K. Osteosarcoma relapse after combined modality therapy: an analysis of unselected patients in the Cooperative Osteosarcoma Study Group (COSS). J Clin Oncol. 2005 Jan 20;23(3):559-68. doi: 10.1200/JCO.2005.04.063.
PubMed 15659502Cheong JH, Hyung WJ, Chen J, Kim J, Choi SH, Noh SH. Surgical management and outcome of metachronous Krukenberg tumors from gastric cancer. J Surg Oncol. 2004 Jul 15;87(1):39-45. doi: 10.1002/jso.20072.
PubMed 15221918van Rijk-Zwikker GL, Nooy MA, Taminiau A, Kappetein AP, Huysmans HA. Pulmonary metastasectomy in patients with osteosarcoma. Eur J Cardiothorac Surg. 1991;5(8):406-9. doi: 10.1016/1010-7940(91)90184-l.
PubMed 1910847Thompson RC Jr, Cheng EY, Clohisy DR, Perentesis J, Manivel C, Le CT. Results of treatment for metastatic osteosarcoma with neoadjuvant chemotherapy and surgery. Clin Orthop Relat Res. 2002 Apr;(397):240-7. doi: 10.1097/00003086-200204000-00028.
PubMed 11953615Navid F, Willert JR, McCarville MB, Furman W, Watkins A, Roberts W, Daw NC. Combination of gemcitabine and docetaxel in the treatment of children and young adults with refractory bone sarcoma. Cancer. 2008 Jul 15;113(2):419-25. doi: 10.1002/cncr.23586.
PubMed 18484657Berger M, Grignani G, Ferrari S, Biasin E, Brach del Prever A, Aliberti S, Saglio F, Aglietta M, Fagioli F. Phase 2 trial of two courses of cyclophosphamide and etoposide for relapsed high-risk osteosarcoma patients. Cancer. 2009 Jul 1;115(13):2980-7. doi: 10.1002/cncr.24368.
PubMed 19452540Saylors RL 3rd, Stine KC, Sullivan J, Kepner JL, Wall DA, Bernstein ML, Harris MB, Hayashi R, Vietti TJ; Pediatric Oncology Group. Cyclophosphamide plus topotecan in children with recurrent or refractory solid tumors: a Pediatric Oncology Group phase II study. J Clin Oncol. 2001 Aug 1;19(15):3463-9. doi: 10.1200/JCO.2001.19.15.3463.
PubMed 11481351Miser JS, Kinsella TJ, Triche TJ, Tsokos M, Jarosinski P, Forquer R, Wesley R, Magrath I. Ifosfamide with mesna uroprotection and etoposide: an effective regimen in the treatment of recurrent sarcomas and other tumors of children and young adults. J Clin Oncol. 1987 Aug;5(8):1191-8. doi: 10.1200/JCO.1987.5.8.1191.
PubMed 3114435McNall-Knapp RY, Williams CN, Reeves EN, Heideman RL, Meyer WH. Extended phase I evaluation of vincristine, irinotecan, temozolomide, and antibiotic in children with refractory solid tumors. Pediatr Blood Cancer. 2010 Jul 1;54(7):909-15. doi: 10.1002/pbc.22460.
PubMed 20405511Bomgaars LR, Bernstein M, Krailo M, Kadota R, Das S, Chen Z, Adamson PC, Blaney SM. Phase II trial of irinotecan in children with refractory solid tumors: a Children's Oncology Group Study. J Clin Oncol. 2007 Oct 10;25(29):4622-7. doi: 10.1200/JCO.2007.11.6103.
PubMed 17925558Cosetti M, Wexler LH, Calleja E, Trippett T, LaQuaglia M, Huvos AG, Gerald W, Healey JH, Meyers PA, Gorlick R. Irinotecan for pediatric solid tumors: the Memorial Sloan-Kettering experience. J Pediatr Hematol Oncol. 2002 Feb;24(2):101-5. doi: 10.1097/00043426-200202000-00009.
PubMed 11990694Debiec-Rychter M, Sciot R, Le Cesne A, Schlemmer M, Hohenberger P, van Oosterom AT, Blay JY, Leyvraz S, Stul M, Casali PG, Zalcberg J, Verweij J, Van Glabbeke M, Hagemeijer A, Judson I; EORTC Soft Tissue and Bone Sarcoma Group; Italian Sarcoma Group; Australasian GastroIntestinal Trials Group. KIT mutations and dose selection for imatinib in patients with advanced gastrointestinal stromal tumours. Eur J Cancer. 2006 May;42(8):1093-103. doi: 10.1016/j.ejca.2006.01.030. Epub 2006 Apr 18.
PubMed 16624552Shepherd FA, Rodrigues Pereira J, Ciuleanu T, Tan EH, Hirsh V, Thongprasert S, Campos D, Maoleekoonpiroj S, Smylie M, Martins R, van Kooten M, Dediu M, Findlay B, Tu D, Johnston D, Bezjak A, Clark G, Santabarbara P, Seymour L; National Cancer Institute of Canada Clinical Trials Group. Erlotinib in previously treated non-small-cell lung cancer. N Engl J Med. 2005 Jul 14;353(2):123-32. doi: 10.1056/NEJMoa050753.
PubMed 16014882
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Apatinib in Relapsed and Unresectable High-grade Osteosarcoma After Failure of Standard Multimodal Therapy
- ClinicalTrials.gov ID
- NCT02711007
- Acronym / sponsor ID
- PKUPH-sarcoma
- Conditions
- Osteosarcoma, Metastasis
- Keywords
- osteosarcoma, metastasis, advanced, apatinib
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- GUO WEIUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- 30 Dec 2017 (actual)
- Study completion
- 8 Jan 2018 (actual)
- First posted
- 17 Mar 2016 (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.
After standard multimodal therapy, the prognosis of relapsed and unresectable high-grade osteosarcoma is dismal and unchanged over the last decades.Thus, the investigators explored apatinib activity in patients with relapsed and unresectable osteosarcoma after the failure of first-line or second-line chemotherapy. Patients >16 years, progressing after standard treatment, were eligible to receive 500 mg or 750 mg of apatinib once daily until progression or unacceptable toxicity. The primary end point was progression-free survival (PFS) at 4 months and objective response rate (ORR). Secondary objectives were PFS, overall survival (OS), clinical benefit rate (CBR), defined as no progression at 6 months and safety.
Detailed description
Patients
Eligible patients should have the following characteristics: age >16 years; diagnosis of high-grade osteosarcoma confirmed histologically and reviewed centrally; prior treatment (completed >4 weeks before trial entry) consisted of standard high-grade osteosarcoma chemotherapy agents including doxorubicin, cisplatin, high-dose methotrexate, and ifosfamide; metastatic relapsed and unresectable progressive disease (PD); Eastern Cooperative Oncology Group performance status 0-1 with a life expectancy >3 months; adequate renal, hepatic, and hemopoietic function. Additionally, the investigators require normal or controlled blood pressure, as well as surgery and/or radiotherapy completion at least 1 month before enrollment. All enrolled patients showed radiological evidence of disease progression and the lesion could be evaluated according to RECIST 1.1 before treatment start.
Treatment
Patients are planned to be treated with a dose of apatinib 500 mg(BSA ≤1.5) or 750mg(BSA>1.5) once daily. The dose was reduced or temporarily suspended according to predefined rules and after considering any observed toxicity, which was assessed according to the Common Terminology Criteria for Adverse Events version 3.0. Following adverse event resolution, apatinib can be restarted at the maximally tolerated dose and continued until progression, unacceptable toxicity or patient refusal. The study was approved by participating hospital review boards, and conducted according to the Declaration of Helsinki and the International Conference on Harmonization of Good Clinical Practice guidelines. Each patient provided written informed consent.
Efficacy Assessment
Before starting treatment, patients should be staged with chest and abdomen computed tomography (CT) and magnetic resonance imaging (MRI) (whenever indicated by the clinical situation). And all those patients should be tested by Immunohistochemistry of the VEGFR-2 over-expression of the paraffin embedded samples of the lesion or mRNA testing VEGFR-2 over-expression of the fresh specimen. Baseline assessment included also full blood count, serum chemistry, electrocardiogram and physical examination. In light of its potential role in osteosarcoma response assessment, [18F]2-fluoro-2-deoxy-D-glucose-positron emission tomography (FDG-PET) is suggested but not mandated for patient enrollment, and its impact on tumor response assessment was purely exploratory. All tests were repeated after 2 months and, thereafter, at 2-month intervals unless there were toxic effects or disease progression suspicion. Response was assessed by CT/MRI scan according to RECIST 1.1. Thus, both complete and partial remission needed confirmation within 4 weeks of when a response was first demonstrated. Stable disease (SD) was confirmed after a minimum of 8 weeks. The investigators thoroughly probe for and record any sign(s) of treatment-induced improvement, be it minor response (MR) as tumor shrinkage <30%, and/or nondimensional tumor responses including Hounsfield unit measured tissue density changes or osteoid matrix calcification.
The primary end point progression-free survival (PFS) at 4 months is calculated from the date of treatment start until the time of disease progression or death, whichever came first. Patients alive and free from progression would be censored. Secondary end points included the following: PFS; OS; overall response rate, defined as complete responses (CRs) + partial responses (PRs) + MRs; disease control rate (overall response rate + SDs); patterns of nondimensional response; clinical benefit rate (CBR) (PFS rate at 4 months) and duration of response. Duration of response is calculated from the day of first response assessment until either progression/death (event) or last day of follow-up (censored). Last, the investigators evaluate any clinical improvement by means of the Pain Analgesic Score via the Brief Pain Inventory (BPI) score form that was filled in by patients themselves. Analgesic medication use was recorded according to the analgesic score: 0 = none; 1 = minor analgesics; 2 = tranquillizers, antidepressants, muscle relaxants and steroids; 3 = mild narcotics; 4 = strong narcotics.
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 750mg tablet or 500mg tablet by mouth, Qd half an hour after dinner |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- age >16 years;
- diagnosis confirmed histologically and reviewed centrally;
- prior treatment (completed >4 weeks before trial entry) consisted of standard high-grade osteosarcoma chemotherapy agents including doxorubicin, cisplatin, high- dose methotrexate, and ifosfamide; metastatic relapsed and unresectable progressive disease (PD);
- Eastern Cooperative Oncology Group performance status 0-1 with a life expectancy >3 months;
- adequate renal, hepatic, and hemopoietic function;
Key exclusion criteria (10 listed)
- no pulmonary artery or venous tumor embolus;
- previously exposed to other TKIs;
- central nervous system metastasis;
- have had other kinds of malignant tumors at the same time;
- cardiac insufficiency or arrhythmia;
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 is a small-molecule VEGFR tyrosine kinase inhibitor, similar to vatalanib (PTK787), but with a binding affinity 10 times that of vatalanib or sorafenib. | Drug | apatinib |
Primary outcome
Progression-free survival, PFS
Time frame: 4 months
calculated from the date of treatment start until the time of disease progression or death, whichever comes first.
Objective response rate, ORR
Time frame: 3 months
CR+PR at 3 months
3 secondary outcomes
Overall survival, OS
Time frame: 12 months
Clinical benefit rate, CBR
Time frame: 6 months
Duration of response, DOR
Time frame: 6 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 23 Apr 2018.
- Background: PubMed 22648705Bernthal NM, Federman N, Eilber FR, Nelson SD, Eckardt JJ, Eilber FC, Tap WD. Long-term results (>25 years) of a randomized, prospective clinical trial evaluating chemotherapy in patients with high-grade, operable osteosarcoma. Cancer. 2012 Dec 1;118(23):5888-93. doi: 10.1002/cncr.27651. Epub 2012 May 30.
- Background: PubMed 20213397Bielack S, Jurgens H, Jundt G, Kevric M, Kuhne T, Reichardt P, Zoubek A, Werner M, Winkelmann W, Kotz R. Osteosarcoma: the COSS experience. Cancer Treat Res. 2009;152:289-308. doi: 10.1007/978-1-4419-0284-9_15.
- Background: PubMed 15659502Kempf-Bielack B, Bielack SS, Jurgens H, Branscheid D, Berdel WE, Exner GU, Gobel U, Helmke K, Jundt G, Kabisch H, Kevric M, Klingebiel T, Kotz R, Maas R, Schwarz R, Semik M, Treuner J, Zoubek A, Winkler K. Osteosarcoma relapse after combined modality therapy: an analysis of unselected patients in the Cooperative Osteosarcoma Study Group (COSS). J Clin Oncol. 2005 Jan 20;23(3):559-68. doi: 10.1200/JCO.2005.04.063.
- Background: PubMed 15221918Cheong JH, Hyung WJ, Chen J, Kim J, Choi SH, Noh SH. Surgical management and outcome of metachronous Krukenberg tumors from gastric cancer. J Surg Oncol. 2004 Jul 15;87(1):39-45. doi: 10.1002/jso.20072.
- Background: PubMed 1910847van Rijk-Zwikker GL, Nooy MA, Taminiau A, Kappetein AP, Huysmans HA. Pulmonary metastasectomy in patients with osteosarcoma. Eur J Cardiothorac Surg. 1991;5(8):406-9. doi: 10.1016/1010-7940(91)90184-l.
- Background: PubMed 11953615Thompson RC Jr, Cheng EY, Clohisy DR, Perentesis J, Manivel C, Le CT. Results of treatment for metastatic osteosarcoma with neoadjuvant chemotherapy and surgery. Clin Orthop Relat Res. 2002 Apr;(397):240-7. doi: 10.1097/00003086-200204000-00028.
- Background: PubMed 18484657Navid F, Willert JR, McCarville MB, Furman W, Watkins A, Roberts W, Daw NC. Combination of gemcitabine and docetaxel in the treatment of children and young adults with refractory bone sarcoma. Cancer. 2008 Jul 15;113(2):419-25. doi: 10.1002/cncr.23586.
- Background: PubMed 19452540Berger M, Grignani G, Ferrari S, Biasin E, Brach del Prever A, Aliberti S, Saglio F, Aglietta M, Fagioli F. Phase 2 trial of two courses of cyclophosphamide and etoposide for relapsed high-risk osteosarcoma patients. Cancer. 2009 Jul 1;115(13):2980-7. doi: 10.1002/cncr.24368.
- Background: PubMed 11481351Saylors RL 3rd, Stine KC, Sullivan J, Kepner JL, Wall DA, Bernstein ML, Harris MB, Hayashi R, Vietti TJ; Pediatric Oncology Group. Cyclophosphamide plus topotecan in children with recurrent or refractory solid tumors: a Pediatric Oncology Group phase II study. J Clin Oncol. 2001 Aug 1;19(15):3463-9. doi: 10.1200/JCO.2001.19.15.3463.
- Background: PubMed 3114435Miser JS, Kinsella TJ, Triche TJ, Tsokos M, Jarosinski P, Forquer R, Wesley R, Magrath I. Ifosfamide with mesna uroprotection and etoposide: an effective regimen in the treatment of recurrent sarcomas and other tumors of children and young adults. J Clin Oncol. 1987 Aug;5(8):1191-8. doi: 10.1200/JCO.1987.5.8.1191.
- Background: PubMed 20405511McNall-Knapp RY, Williams CN, Reeves EN, Heideman RL, Meyer WH. Extended phase I evaluation of vincristine, irinotecan, temozolomide, and antibiotic in children with refractory solid tumors. Pediatr Blood Cancer. 2010 Jul 1;54(7):909-15. doi: 10.1002/pbc.22460.
- Background: PubMed 17925558Bomgaars LR, Bernstein M, Krailo M, Kadota R, Das S, Chen Z, Adamson PC, Blaney SM. Phase II trial of irinotecan in children with refractory solid tumors: a Children's Oncology Group Study. J Clin Oncol. 2007 Oct 10;25(29):4622-7. doi: 10.1200/JCO.2007.11.6103.
- Individual participant dataSharing planned: No. the investigator decide to share all the statistical analysis plan, clinical study report and anlytic code to other researchers
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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.
Wei Guo, M.D. Ph.D. study chair
Chinese Medical Association--Sarcoma group
1 site 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 apatinib in people with Osteosarcoma and Metastasis, run by GUO WEI 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 7 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 23 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 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 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?
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?
Progression-free survival, PFS (time frame: 4 months). The study lists 2 primary outcomes in all. 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 NCT02711007, which also lists 27 linked publications.
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 Apr 2018.