Phase 2 Peripheral Arterial Disease Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who were between 1 and 30 years old at the time of the biopsy that confirmed their diagnosis of non-rhabdomyosarcoma soft tissue sarcoma (NRSTS).
• People who had surgery to remove the tumour before enrolling, provided treatment can begin within 28 days of that surgery.
• People whose general ability to function and carry out daily activities meets a minimum score on a standard health scale (60 or above on the scale used for their age group), including those who use a wheelchair due to paralysis.
• People whose tumour has been identified as a CIC-DUX4 rearranged sarcoma (these patients would be placed in the high-risk group regardless of other factors).
• People with low-risk disease, meaning either a low-grade tumour of any size where complete or near-complete surgical removal is expected or achieved, or a high-grade tumour smaller than 5 cm where complete or near-complete removal is expected or achieved.
• People with intermediate-risk disease, meaning certain tumours that could not initially be removed but where delayed surgery is planned, or high-grade tumours larger than 5 cm that may be removable.
• People with high-risk disease, meaning tumours that have spread to other parts of the body, tumours that cannot be removed and where delayed surgery is not planned, or CIC-DUX4 rearranged sarcoma.
• People whose kidneys are working well enough, based on standard blood or urine tests showing kidney function above a set level for their age and sex.
• People whose liver is working well enough, based on blood tests showing liver enzyme and bilirubin levels within acceptable ranges for their age.
• People whose heart is working well enough, with a pumping function above 55% on an echocardiogram or cardiac MRI, and a normal heart rhythm measurement (QTc below 480 milliseconds).
• People whose lungs are working well enough, meaning no breathlessness at rest, no inability to tolerate physical activity, and an oxygen level above 94% when breathing normal room air.
• People (in the intermediate- and high-risk groups) whose bone marrow is producing enough blood cells, based on blood count results meeting minimum levels for their age.
• People who are taking blood thinners (such as low molecular weight heparin, warfarin with a stable dose, or direct oral anticoagulants), provided their dose has been stable — and if being treated for a blood clot, that treatment has been ongoing for at least 6 weeks before starting the trial.
• People who have a life expectancy of at least 3 months with appropriate treatment.

Who may not be able to join:

• People whose sarcoma started in the brain or central nervous system, or whose cancer has spread there.
• People whose tumour is one of the following specific types: intermediate locally aggressive tumours (as defined by the WHO), malignant rhabdoid tumour, alveolar soft part sarcoma, infantile fibrosarcoma, unresectable or metastatic dermatofibrosarcoma protuberans, inflammatory myofibroblastic tumour, desmoid fibromatosis, rhabdomyosarcoma, desmoplastic small round cell tumour, or BCOR-CCNB3 fusion positive sarcoma.
• People who have signs of active bleeding or a condition that causes abnormal bleeding (people over 17 years with more than 2.5 mL of coughed-up blood are also not eligible).
• People with high blood pressure that is not well controlled, unless it has been stable on medication for at least two weeks.
• People who have previously received any systemic (whole-body) treatment for their NRSTS.
• People who have previously received certain chemotherapy drugs called anthracyclines or ifosfamide.
• People who have previously taken pazopanib or a similar type of targeted therapy drug.
• People who have previously had radiation therapy to the area where the tumour is located.
• People who have received chemotherapy or radiation therapy within the past 4 weeks (or 6 weeks for certain specific drugs), or who have not yet recovered from side effects of earlier treatment.
• People who are regularly taking certain medications that interact with a liver enzyme called CYP3A4 and have a very narrow safe dosing range (such as pimozide, aripiprazole, triazolam, ergotamine, or halofantrine) within 7 days before enrolling.
• People who are regularly taking strong medications known to block the CYP3A4 liver enzyme (such as itraconazole, clarithromycin, erythromycin, diltiazem, verapamil, or consuming grapefruit juice) within 7 days before enrolling.
• People who are regularly taking strong medications known to activate the CYP3A4 liver enzyme (such as carbamazepine, phenobarbital, phenytoin, rifampin, or St. John's Wort) within 14 days before enrolling (steroids are an exception).
• People who have a condition that affects their ability to absorb oral medications, such as having had major stomach or small bowel surgery, active stomach ulcers, or a malabsorption condition.
• People who require thyroid hormone replacement therapy but have not been on a stable dose for at least 4 weeks before enrolling.
• People who have conditions that increase the risk of stomach or bowel bleeding or perforation, including active stomach ulcers, certain bowel lesions, inflammatory bowel disease (such as Crohn's disease or ulcerative colitis), or a history of abdominal fistula, bowel perforation, or abdominal abscess within the past 28 days.
• People who have had an untreated blood clot in the lung or leg within the past 6 months, a treated clot that has only been treated for less than 6 weeks, or an arterial blood clot within the past 12 months.
• People with a serious or unhealed wound, ulcer, or bone fracture.
• People with an uncontrolled ongoing infection, symptomatic heart failure, unstable chest pain, irregular heart rhythm, or a mental health or personal situation that would make it difficult to follow the trial requirements.
• People living with HIV who are on combination antiretroviral therapy.
• People who are currently taking part in another clinical trial involving an investigational treatment.
• People who are currently pregnant.
• People who are breastfeeding, unless they agree not to breastfeed during treatment and for at least 1 month after treatment ends.
• Female patients of childbearing potential unless a negative pregnancy test result has been confirmed before enrolling.
• People who are sexually active with the potential to conceive or father a child and are unwilling to use effective contraception throughout the trial and for at least 1 month after treatment ends.

Important: Always verify eligibility with the trial site directly before applying.