OsteosarcomaPhase 1/2NCT05590572
A Study of Sulfatinib on Relapsed or Refractory Drug Resistant Osteosarcoma
A Phase 1/2 study testing Sulfatinib, Etoposide and Isophosphamide in people with Osteosarcoma, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 5 sites in 2 countries.
Trial summary
This is a phase 1/2 study evaluating safety, tolerability, and efficacy of Sulfatinib in combination with chemotherapy (ifosfamide and etoposide) in children and adolescents with refractory or relapsed osteosarcoma ( combination Sulfatinib). Read more about this study
- Who is it for?
- Ages 2 to 25 years
- Conditions the study is for
- Osteosarcoma
- What is being tested?
- Sulfatinib, Etoposide and Isophosphamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Jan 2023to Dec 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 2 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Osteosarcoma subjects Male or female participants aged 2 to 25 years at the time of informed consent(Histologically or cytologically confirmed diagnosis of high grade osteosarcoma)
- Recurrent or refractory solid tumor malignancies that have treated with standard anticancer therapy but have no available treatment options.
- Evaluable or measurable disease that met the following criteria: 1. Participants must have an evaluable or measurable disease based on RECIST 1.1, using computed tomography (CT)/ magnetic resonance imaging (MRI). 2. Lesions that have been treated locally, such as external beam radiation therapy (EBRT) or radiofrequency (RF) ablation, must subsequently grow clearly to be considered target lesions.
- Life expectancy is 3 months or more.
- Adequate bone marrow function : ①. Absolute neutrophil count (ANC) ≥ 1.0 x 10^9/L. ②. Hemoglobin ≥ 8.0 g/ deciliter (hemoglobin ≤ 8.0 g/ deciliter is acceptable if corrected by growth factors or transfusion before starting sovanitinib). ③. Platelet count ≥ 75 x 10^9/L.
- Adequate liver function: 1. Bilirubin ≤ 1.5 times the upper limit of normal (ULN). 2. Alkaline phosphatase, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 times of ULN.
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- Adequate renal function, such as creatinine clearance (or radioisotope glomerular filtration rate [GFR]), must be greater than 70 mL/min/ 1.73 square meters.
- (8)A baseline left ventricular ejection fraction (LVEF) of 50% or greater, as determined by echocardiography, indicates adequate cardiac function.
- Good control of blood pressure (BP) with or without antihypertensive medication was defined as : blood pressure below 95% for sex, age, and height/length at screening (according to National Heart, Lung, and Blood Institute guidelines) and no change in antihypertensive medication during the cycle 1 of project. participants with osteosarcoma had blood pressure ≤150/90 mm Hg at screening and had no change in antihypertensive therapy during the cycle 1 of project.
- (10)Parents or legal representative (guardian) shall sign the written informed consent and obtain the consent of minor participants. Written informed consent from subjects ≥18 years of age. Willing and able to abide by the researchers determine solutions, plans, and toxicity of follow-up management.
Who cannot join
- Any active infection or infectious disease.
- Any medical condition or other condition that the investigator believes will prevent the participant from participating in the clinical study.
- Other organ toxicity (except hair loss) caused by previous anti-cancer treatment (research drug, chemotherapy or radiotherapy)
- Known hypersensitivity to any component of the product (soventinib or ingredient).
- Any other anti-tumor treatment is given at the same time.
- He has been treated with sovantinib before.
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- Two or more previous VEGF/VEGFR targeted therapies.
- Currently receiving any study drug or device in another clinical trial or within 30 days before informed consent.
- Clinically significant ECG abnormalities, including significant baseline QT or QTc interval prolongation (e.g., QTc interval duplication is demonstrated to be greater than 480 milliseconds).
- Gastrointestinal malabsorption or any other condition that the investigator believes may affect the absorption of sovantinib.
- Gastrointestinal bleeding or active hemoptysis (at least half a teaspoon of bright red blood) occurred within 3 weeks before the first administration of the study drug.
- Active second malignant tumor (excluding superficial melanoma, in situ, basal or squamous cell skin cancer with definite treatment) within 2 years before enrollment.
- Previously treated with ifosfamide with nephrotoxicity or encephalopathy grade greater than or equal to grade 3.
- Women who were breastfeeding or pregnant at the time of screening or baseline. If a negative screening pregnancy test is obtained more than 72 hours before the first administration of the study drug, a separate baseline assessment is required.
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Trial locations and contacts
5 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
5 sites in 2 countries
China4 sites
Peking University People's Hospital
Beijing, Beijing Municipality, 100000
Yi Yang, PhD, 13701312827, 13701312827@163.com
Qilu Hospital of Shandong University
Jinan, Shandong, 250000
Zhenfeng Li, PhD, 13668812855
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200000
Weibin Zhang, PhD, 13501824630, zhangweibin10368@163.com
Department of Orthopaedic Surgery, Sixth People's Hospital, Shanghai Jiao Tong University,
Shanghai, Shanghai Municipality, 200233
South Korea1 site
Department of Orthopedic Surgery Chonnam National University
Donggu, Gwangju, 999007
Sung Taek Jung, PhD, stjung@jnu.ac.kr
About this study
Official title: A Study of Etoposide and Ifosfamide Combined With or Without Sulfatinib on Relapsed or Refractory Drug Resistant Osteosarcoma
This is a phase 1/2 study evaluating safety, tolerability, and efficacy of Sulfatinib in combination with chemotherapy (ifosfamide and etoposide) in children and adolescents with refractory or relapsed osteosarcoma ( combination Sulfatinib).
Read the detailed description
The study consists of 2 cohorts:
Cohort 1 (Traditional chemotherapy) will evaluate the efficacy of ifosfamide and etoposide in children, adolescents, and young adults with relapsed or refractory osteosarcoma.
Cohort 2 (Combination Expansion) will evaluate the efficacy of Sulfatinib in combination with ifosfamide and etoposide in children, adolescents, and young adults with relapsed or refractory osteosarcoma.
Sulfatinib will be provided as hard capsules containing 300 mg Sulfatinib. Sulfatinib capsules should be dissolved in water or apple juice for those who are unable to swallow capsules.
- Conditions
- Osteosarcoma
- Being tested
- Sulfatinib, Etoposide, Isophosphamide
- Keywords
- Refractory or Relapsed osteosarcoma, Sulfatinib, Tyrosine kinase inhibitors, Etoposide, Ifosfamide
- Medical subject headings
- Osteosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SulfatinibDrug
(1) Sulfatinib: 300 mg, oral once a day (QD), 21 days as a cycle
EtoposideDrug
(1) Etoposide: 100 mg/m2/day (initial dose) will be administered on the first to third days of each 21 day cycle, a total of 5 cycles. The dose of etoposide can be reduced to 80 mg/m2/day and 60 mg/m2/day.;
IsophosphamideDrug
(1) Isophosphamide: 3000 mg/m2/day (initial dose) will be administered on the first to third days of each 21 day cycle for 5 cycles. The dose of ifosfamide can be reduced to 2400 mg/m2/day and 1800 mg/m2/day.
| Study group | Role | What they receive |
|---|---|---|
| Etoposide plus Ifosfamide group | Active comparator | Children and adolescents with relapsed or refractory drug resistant osteosarcoma Receives: Drug: Etoposide; Drug: Isophosphamide |
| Etoposide plus Ifosfamide Combined With Sulfatinib | Experimental | Children and adolescents with relapsed or refractory drug resistant osteosarcoma Receives: Drug: Sulfatinib; Drug: Etoposide; Drug: Isophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
4 months progression-free survival
The proportion of patients who had no objective tumor progression or death from the start of treatment to 4 months of follow-up.
Measured: 4 months
Efficacy evaluation in solid tumors
Complete response (CR), all target and non-target lesions (non-lymph nodes) disappear, and the diameter of all pathologic lymph nodes (both target and non-target) must be reduced to <10 mm; Partial response (PR), using baseline total diameter as reference, reduced the total diameter of target lesions by at least 30%.
Measured: 2 months
Secondary outcomes (2)
Best of response,BOR
From the date of the first administration of the study drug to disease progression or death, whichever occurs first.
Measured: 4 months
Duration of Remission (DOR)
Complete response (CR)/ partial response (PR) was first recorded until disease progression was first recorded until the data cutoff date.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2022
- Study startJan 2023 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Chonnam National University, Peking University People's Hospital, Qilu Hospital of Shandong University, Ruijin Hospital, Shanghai Jiao Tong University Affiliated Sixth People's Hospital
- Responsible party
- Sponsor
- Investigators
- zhaoming Ye, PhD, Study chair, Second Affiliated Hospital, Zhejiang University, School of MedicineBinhao Li, PhD, Study director, Second Affiliated Hospital, Zhejiang University, School of Medicinezengjie zhang, MD, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of MedicineShengdong Wang, MD, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of MedicineXin Huang, PhD, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of MedicinePeng Lin, MD, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05590572
- Sponsor's protocol ID
- 2022-0880
- Status last verified
- Oct 2022
- First submitted
- 19 Oct 2022
- Last updated
- 21 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 21 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Etoposide and Ifosfamide Combined With or Without Sulfatinib on Relapsed or Refractory Drug Resistant Osteosarcoma
- ClinicalTrials.gov ID
- NCT05590572
- Acronym / sponsor ID
- 2022-0880
- Conditions
- Osteosarcoma
- Keywords
- Refractory or Relapsed osteosarcoma, Sulfatinib, Tyrosine kinase inhibitors, Etoposide, Ifosfamide
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- Chonnam National University, Peking University People's Hospital, Qilu Hospital of Shandong University, Ruijin Hospital, Shanghai Jiao Tong University Affiliated Sixth People's Hospital
- Study start
- Jan 2023 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 21 Oct 2022 (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.
This is a phase 1/2 study evaluating safety, tolerability, and efficacy of Sulfatinib in combination with chemotherapy (ifosfamide and etoposide) in children and adolescents with refractory or relapsed osteosarcoma ( combination Sulfatinib).
Detailed description
The study consists of 2 cohorts:
Cohort 1 (Traditional chemotherapy) will evaluate the efficacy of ifosfamide and etoposide in children, adolescents, and young adults with relapsed or refractory osteosarcoma.
Cohort 2 (Combination Expansion) will evaluate the efficacy of Sulfatinib in combination with ifosfamide and etoposide in children, adolescents, and young adults with relapsed or refractory osteosarcoma.
Sulfatinib will be provided as hard capsules containing 300 mg Sulfatinib. Sulfatinib capsules should be dissolved in water or apple juice for those who are unable to swallow capsules.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Etoposide plus Ifosfamide group | Active comparator | Drug: Etoposide, Drug: IsophosphamideChildren and adolescents with relapsed or refractory drug resistant osteosarcoma |
| Etoposide plus Ifosfamide Combined With Sulfatinib | Experimental | Drug: Sulfatinib, Drug: Etoposide, Drug: IsophosphamideChildren and adolescents with relapsed or refractory drug resistant osteosarcoma |
Who may qualify
- Ages
- 2 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- Osteosarcoma subjects Male or female participants aged 2 to 25 years at the time of informed consent(Histologically or cytologically confirmed diagnosis of high grade osteosarcoma)
- Recurrent or refractory solid tumor malignancies that have treated with standard anticancer therapy but have no available treatment options.
- Evaluable or measurable disease that met the following criteria: 1. Participants must have an evaluable or measurable disease based on RECIST 1.1, using computed tomography (CT)/ magnetic resonance imaging (MRI). 2. Lesions that have been treated locally, such as external beam radiation therapy (EBRT) or radiofrequency (RF) ablation, must subsequently grow clearly to be considered target lesions.
- Life expectancy is 3 months or more.
- Adequate bone marrow function : ①. Absolute neutrophil count (ANC) ≥ 1.0 x 10^9/L. ②. Hemoglobin ≥ 8.0 g/ deciliter (hemoglobin ≤ 8.0 g/ deciliter is acceptable if corrected by growth factors or transfusion before starting sovanitinib). ③. Platelet count ≥ 75 x 10^9/L.
Key exclusion criteria (15 listed)
- Any active infection or infectious disease.
- Any medical condition or other condition that the investigator believes will prevent the participant from participating in the clinical study.
- Other organ toxicity (except hair loss) caused by previous anti-cancer treatment (research drug, chemotherapy or radiotherapy)
- Known hypersensitivity to any component of the product (soventinib or ingredient).
- Any other anti-tumor treatment is given at the same time.
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 |
|---|---|---|
| Sulfatinib(1) Sulfatinib: 300 mg, oral once a day (QD), 21 days as a cycle | Drug | Etoposide plus Ifosfamide Combined With Sulfatinib |
| Etoposide(1) Etoposide: 100 mg/m2/day (initial dose) will be administered on the first to third days of each 21 day cycle, a total of 5 cycles. The dose of etoposide can be reduced to 80 mg/m2/day and 60 mg/m2/day.; | Drug | Etoposide plus Ifosfamide Combined With Sulfatinib, Etoposide plus Ifosfamide group |
| Isophosphamide(1) Isophosphamide: 3000 mg/m2/day (initial dose) will be administered on the first to third days of each 21 day cycle for 5 cycles. The dose of ifosfamide can be reduced to 2400 mg/m2/day and 1800 mg/m2/day. | Drug | Etoposide plus Ifosfamide Combined With Sulfatinib, Etoposide plus Ifosfamide group |
Primary outcome
4 months progression-free survival
Time frame: 4 months
The proportion of patients who had no objective tumor progression or death from the start of treatment to 4 months of follow-up.
Efficacy evaluation in solid tumors
Time frame: 2 months
Complete response (CR), all target and non-target lesions (non-lymph nodes) disappear, and the diameter of all pathologic lymph nodes (both target and non-target) must be reduced to <10 mm; Partial response (PR), using baseline total diameter as reference, reduced the total diameter of target lesions by at least 30%.
2 secondary outcomes
Best of response,BOR
Time frame: 4 months
Duration of Remission (DOR)
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2022.
- 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.
zhaoming Ye, PhD study chair
Second Affiliated Hospital, Zhejiang University, School of Medicine
Binhao Li, PhD study director
Second Affiliated Hospital, Zhejiang University, School of Medicine
zengjie zhang, MD principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Sulfatinib, Etoposide and Isophosphamide in people with Osteosarcoma, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 5 sites in 2 countries.
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 10 inclusion and 15 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: opening soon, as of the sponsor's last update on 21 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China, South Korea. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhaoming Ye, PhD (13606501549, yezhaoming@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
4 months progression-free survival (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?
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 21 Oct 2022; AzTrials last refreshed its copy on 26 Oct 2026.