Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Rare Diseases

Osteosarcoma

Neoplasms, Bone Tissue

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Sarcoma

Soft Tissue Sarcoma

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Etoposide

Ifosfamide

Etoposide phosphate

Tyrosine Kinase Inhibitors

Isophosphamide mustard

Mechlorethamine

Enzyme Inhibitors

Antineoplastic Agents, Alkylating

Alkylating Agents

Tyrosine

Children and adolescents with relapsed or refractory drug resistant osteosarcoma

(1) Sulfatinib: 300 mg, oral once a day (QD), 21 days as a cycle

Sulfatinib

(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.;

(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.

Isophosphamide

Zhaoming Ye, PhD

zengjie zhang, MD

Yi Yang, PhD

Zhenfeng Li, PhD

Weibin Zhang, PhD

Sung Taek Jung, PhD

zhaoming Ye, PhD

Binhao Li, PhD

Shengdong Wang, MD

Xin Huang, PhD

Peng Lin, MD

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).

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.

A Study of Sulfatinib on Relapsed or Refractory Drug Resistant Osteosarcoma

A Study of Etoposide and Ifosfamide Combined With or Without Sulfatinib on Relapsed or Refractory Drug Resistant Osteosarcoma

The proportion of patients who had no objective tumor progression or death from the start of treatment to 4 months of follow-up.

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%.

From the date of the first administration of the study drug to disease progression or death, whichever occurs first.

Complete response (CR)/ partial response (PR) was first recorded until disease progression was first recorded until the data cutoff date.

Chonnam National University

Peking University People's Hospital

Qilu Hospital of Shandong University

Ruijin Hospital

Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Second Affiliated Hospital, School of Medicine, Zhejiang University

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Neuroendocrine Tumor

Neuroepithelioma

Sulfatinib 300 mg once a day (QD) will be orally administrated on a 28-day cycle.

Jing Li, MD

a multicenter, open-label phase Ib study to determine the safety, tolerability and preliminary efficacy of Sulfatinib 300 mg once a day in treating advanced neuroendocrine tumors

The study population is patients with low- or intermediate-grade (G1 or G2) advanced NET who have failed in standard treatment or are unable to receive standard treatment.Sulfatinib 300 mg once a day (QD) will be orally administrated on a 28-day cycle. Investigators will evaluate the clinical tumor response to Sulfatinib, and if investigators determine that the patient can benefit from the continuation of treatment, the patient will continue the Sulfatinib treatment. The duration of study will be 2 years. At the time of study completion, if investigators believe patients can continue to benefit from the investigational product, patients may be provided with Sulfatinib with the agreement of the sponsor.

Phase Ib/II Study of Sulfatinib in Treating Advanced Neuroendocrine Tumors

A Multi-Center, Open-Label, Phase Ib/II Clinical Trial to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Sufatinib in Treating Advanced Neuroendocrine Tumors

Hutchison Medipharma Limited

cohort 1: Sulfatinib single oral dosing;after 7days,Sulfatinib continuous oral dosing ( once a day) 28days as a cycle.

Sulfatinib is a capsule in the form of25, 50mg , 100mg; oral, once a day

Ming J Xu, PHD

Sulfatinib (HMPL-012) is a novel oral small molecule that selectively inhibits vascular endothelial growth factor receptors (VEGFR) 1, 2, and 3 and inhibits FGFR kinase activity has demonstrated potent inhibitory effects on multiple human tumor xenografts. This first-in-human study is conducted to assess the maximum tolerated dose (MTD) and recommended dose for phase II ,to evaluate the pharmacokinetics , safety and preliminary anti-tumor activity of HMPL-012 at single doses and multiple doses .

This will be an open-label, phase I study. This study will evaluate the safety and pharmacokinetics of HMPL-012 after a single administration followed by a 28-Day continuous course of therapy; evaluate the safety and preliminary efficacy in an open-label administration of at the MTD. All subjects of this study will be permitted to continue therapy with only safety monitoring and monthly assessments for progression, if the product is well tolerated and the subject has stable disease or better

Phase I Study of Sulfatinib(HMPL-012) in Patients With Advanced Solid Tumors

Phase I Study of Safety and Pharmacokinetics of Sulfatinib(HMPL-012) in Patients With Advanced Solid Tumors

Anti-tumoral efficacy will be assessed by best radiographic response based on Response Evaluation Criteria in Solid Tumors (RECIST v 1.0) at baseline (Day -14 to -1) and at the end of two 28-Day cycles of therapy . For patients that continue on repeat 28-Day cycles after the primary evaluation period, progression will be assessed after each two 28-Day cycles of therapy.

The primary endpoint is evaluation of safety during the first 28-day cycle 1 of therapy following the initiation of multiple dosing of HMPL-012. The safety variables to be evaluated in this study are adverse events, physical examinations, vital signs (specifically including blood pressure), clinical laboratory evaluations including serum chemistry, hematology , and urinalysis (with detailed sediment analysis, proteinuria, and 24-hour urine for collection for protein), and electrocardiograms (ECGs) in triplicate

In the study of single-dose, full PK profiles of HMPL-012 will be obtained following administration of a single oral dose of HMPL-012 on Day 1 to Day 3. At multiple-dose, PK sampling will include a pre-dose and at the 1,4,8,12 hour time points on days 1,14,28 of dosing in the first 28-Day cycle of therapy, and pre-dose on days 2, 3, 7, 15 and 29 of the first 28-Day cycle of therapy and pre-dose on days 56 of the cycle 2.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of Sulfatinib on Relapsed or Refractory Drug Resistant Osteosarcoma	NCT05590572	Osteosarcoma	Sulfatinib Etoposide Isophosphamide	2 Years - 25 Years	Second Affiliated Hospital, School of Medicine, Zhejiang University
Phase Ib/II Study of Sulfatinib in Treating Advanced Neuroendocrine Tumors	NCT02267967	Neuroendocrine ...	Sulfatinib	18 Years -	Hutchmed
A Study of Sulfatinib on Relapsed or Refractory Drug Resistant Osteosarcoma	NCT05590572	Osteosarcoma	Sulfatinib Etoposide Isophosphamide	2 Years - 25 Years	Second Affiliated Hospital, School of Medicine, Zhejiang University
Phase I Study of Sulfatinib(HMPL-012) in Patients With Advanced Solid Tumors	NCT02133157	Tumor	Sulfatinib	18 Years - 70 Years	Hutchmed
Phase Ib/II Study of Sulfatinib in Treating Advanced Neuroendocrine Tumors	NCT02267967	Neuroendocrine ...	Sulfatinib	18 Years -	Hutchmed

Spots Global Cancer Trial Database for sulfatinib

Every month we try and update this database with for sulfatinib cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for sulfatinib

Every month we try and update this database with for sulfatinib cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for sulfatinib cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.