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Tests treatment safety and results for Rhabdomyosarcoma, Recurrent, Refractory
Official title Evaluation of the Efficacy and Safety of Pazopanib in Combination with TGI/CIV for Recurrent or Refractory Rhabdomyosarcoma in Children or Adolescents
ClinicalTrials.gov ID: NCT06816771
What this study is testing
What is pazopanib?
pazopanib is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for rhabdomyosarcoma, recurrent, refractory.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- To evaluate the efficacy and safety of pazopanib combined with TGI/CIV chemotherapy in children and adolescents with recurrent or refractory rhabdomyosarcoma.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 to 18
You may be able to join if
- Histologically or cytologically confirmed rhabdomyosarcoma (RMS).
- Patients diagnosed with recurrent/refractory RMS based on clinical diagnostic criteria. Recurrence is defined as disease recurrence confirmed after...
- Patients must have measurable lesions as per RECIST 1.1 criteria.
- Age ≥ 2 years and ≤ 18 years, with no gender restrictions.
- Karnofsky Performance Scale (KPS) score of 70-100% (\> 12 years) or Lansky Performance Scale score of 70-100% (≤ 12 years).
You likely can't join if
- Received any of the following treatments within 2 weeks before treatment: radiotherapy, chemotherapy, or molecular targeted therapy for tumors; other...
- Patients who have received anti-angiogenic targeted drugs such as apatinib, pazopanib, sunitinib, sorafenib, bevacizumab, imatinib, crizotinib...
- Central nervous system metastasis.
- A history of thrombosis within 3 months before enrollment and anticoagulation treatment for less than 6 weeks.
- Known bleeding tendency, significant clinical bleeding symptoms within 3 months before treatment or definite bleeding tendency, such as...
- Uncontrolled hypertension and proteinuria in the recent period. And cannot be well controlled by antihypertensive drugs (infants \> 100/60 mmHg...
See the full eligibility criteria
- Histologically or cytologically confirmed rhabdomyosarcoma (RMS).
- Patients diagnosed with recurrent/refractory RMS based on clinical diagnostic criteria. Recurrence is defined as disease recurrence confirmed after achieving complete remission and completing at least one line of...
- Patients must have measurable lesions as per RECIST 1.1 criteria.
- Age ≥ 2 years and ≤ 18 years, with no gender restrictions.
- Karnofsky Performance Scale (KPS) score of 70-100% (\> 12 years) or Lansky Performance Scale score of 70-100% (≤ 12 years).
- Expected survival time ≥ 12 weeks.
- Before initiating any project-related procedures, the parents/guardians of the child or adolescent people must be able to understand, consent, and sign the informed consent form (ICF) and applicable assent form; the...
- Adequate organ and bone marrow function, defined as follows: Bone marrow function:
- Absolute neutrophil count (ANC) ≥ 1.5×109/L (≥ 0.5×109/L if bone marrow metastasis)
- Platelet count ≥ 100×109/L (≥ 75×109/L if bone marrow metastasis) Hb ≥ 65 g/L (blood transfusion is allowed)
- Hematopoietic growth factors: Treatment should be initiated at least 14 days after the last administration of long-acting growth factors or 1 day after the last administration of short-acting growth factors. renal...
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN (≤ 5 × ULN for patients with liver metastasis)
- Total bilirubin ≤ 1.5 times ULN Cardiac function 1) Echocardiography LVEF ≥ 50%; 2) No severe cardiac rhythm or conduction abnormalities on electrocardiogram.
- Received any of the following treatments within 2 weeks before treatment: radiotherapy, chemotherapy, or molecular targeted therapy for tumors; other investigational drugs; or live attenuated vaccines.
- Patients who have received anti-angiogenic targeted drugs such as apatinib, pazopanib, sunitinib, sorafenib, bevacizumab, imatinib, crizotinib, famitinib, anlotinib, regorafenib, endostatin, etc. within the past 3...
- Central nervous system metastasis.
- A history of thrombosis within 3 months before enrollment and anticoagulation treatment for less than 6 weeks.
- Known bleeding tendency, significant clinical bleeding symptoms within 3 months before treatment or definite bleeding tendency, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, baseline fecal occult blood...
- Uncontrolled hypertension and proteinuria in the recent period. And cannot be well controlled by antihypertensive drugs (infants \> 100/60 mmHg, preschool children (\ 110/70 mmHg, school-age children (6-12 years old) \>...
- Use of antiepileptic drugs.
- Long-term unhealed wounds, ulcers or fractures, major surgery within 28 days before enrollment or minor surgery within 7 days, abdominal fistula, gastrointestinal perforation.
- Uncontrolled severe infection.
- The presence of active heart disease within 6 months before treatment, including myocardial infarction, severe/unstable angina, etc. Poorly controlled arrhythmias with left ventricular ejection fraction \ 450 ms in men...
- Any other malignancy was diagnosed within 3 years before treatment.
- Known allergy to the study drug or any of its excipient.
- Human immunodeficiency virus (HIV) infection, active hepatitis B (hepatitis B surface antigen positive and HBV DNA ≥ 500 IU/ml), hepatitis C (hepatitis C antibody positive and HCV-RNA above the detection limit of the...
- According to the judgment of the researchers, patients with large tumors, easy to rupture and bleeding, and bleeding caused by tumor retraction are at high risk.
- Concomitant medical conditions (e.g., poorly controlled hypertension, severe diabetes, neurological or psychiatric conditions, etc.) or any other condition that, in the investigator's judgment, could seriously endanger...
The study team makes the final eligibility decision.
Where it's taking place
- Jinan, Shandong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jinan, Shandong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.