Tests sulfatinib with chemotherapy in relapsed or refractory osteosarcoma
Tests sulfatinib with chemotherapy in children and young people with returning bone cancer.
Plain-language title generated from the registry record
Registry title: A Study of Sulfatinib on Relapsed or Refractory Drug Resistant Osteosarcoma
Key facts
- Where
- Beijing, Jinan, and Shanghai, ChinaSee the 4 sites
- Phase
- Phase 1/2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 2 and 25 years old?
Source: NCT05590572, who can take part
Where in China
- Peking University People's HospitalBeijing, ChinaNo longer taking part
- Qilu Hospital of Shandong UniversityJinan, ChinaNo longer taking part
- Department of Orthopaedic Surgery, Sixth People's Hospital, Shanghai Jiao Tong University,Shanghai, ChinaNo longer taking part
- Ruijin Hospital, Shanghai Jiao Tong University School of MedicineShanghai, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Trial code
- NCT05590572
- Record updated
- 21 October 2022
- Original description
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 full original descriptionShow less
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).
Inclusion: 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; 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; (9) 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.
Exclusion: Other organ toxicity (except hair loss) caused by previous anti-cancer treatment (research drug, chemotherapy or radiotherapy); He has been treated with sovantinib before; 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; 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; 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; -; 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; Known hypersensitivity to any component of the product (soventinib or ingredient); Gastrointestinal malabsorption or any other condition that the investigator believes may affect the absorption of sovantinib; Active second malignant tumor (excluding superficial melanoma, in situ, basal or squamous cell skin cancer with definite treatment) within 2 years before enrollment; 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); Any other anti-tumor treatment is given at the same time.