Phase 1 Peripheral Neuropathy 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 have been diagnosed with a solid tumour (such as rhabdomyosarcoma, Ewing sarcoma, soft tissue sarcoma, or high-grade brain tumours) or a type of blood cancer called acute leukaemia (AML or ALL), where the cancer has come back or has not responded to previous treatments, confirmed by a pathology laboratory at the NCI.
• People with a specific type of brain tumour called diffuse intrinsic pontine glioma (DIPG) or optic pathway glioma may be eligible without a tissue biopsy, provided their MRI scan shows the typical appearance of these tumours.
• People with a genetic condition called NF1 who also have a type of nerve tumour called malignant peripheral nerve sheath tumour (MPNST).
• People whose cancer has come back or has not responded to standard treatments — there is no limit on how many previous treatments a person has had.
• People whose cancer can be detected or measured at the time of joining the trial, including by specialist laboratory tests for leukaemia.
• People aged 3 to 35 years, who also have a body surface area of at least 0.55 m² (a measure based on height and weight).
• People who are able to understand and sign a consent form, or whose parent or legal guardian can do so on their behalf if they are a minor.
• People who are able to swallow capsules.
• People with a performance status score showing they are reasonably functional — specifically, a Karnofsky score of 50% or higher (for those over 16 years old) or a Lansky score of 50% or higher (for those 16 years old or younger); people who use a wheelchair due to paralysis may still meet this requirement if they are able to be up in their wheelchair.
• People who are able to travel to the NIH for assessments.
• People who have sufficiently recovered from side effects of previous cancer treatments, with specific waiting periods required depending on the type of treatment previously received (confirm exact waiting periods with the trial site).
• People with brain tumours who are taking steroids, provided their neurological symptoms are not getting worse and their steroid dose has been stable or reducing for at least 7 days before joining.
• People with leukaemia taking steroids or hydroxyurea, provided these are not being used to manage a transplant complication called graft-versus-host disease, and the dose has not increased in the 7 days before starting the study drug.
• People with adequate blood, liver, and kidney function, meeting all of the following: a neutrophil count of at least 1.5 × 10⁹/L; haemoglobin above 10 g/dL; platelet count of at least 100 × 10⁹/L; liver enzyme levels (AST and ALT) within the normal range; bilirubin levels within the normal range (with a slightly higher allowance for people with a known condition called Gilbert's syndrome); and a creatinine level no more than 1.5 times the upper limit of normal.
• People whose heart pumps at least 50% of its capacity (ejection fraction), and whose heart rhythm measurement (QTcF interval) is under 450 ms for males or under 470 ms for females on a baseline ECG.
• Women who could become pregnant, and men who could father a child, who agree to use effective contraception during the trial and for at least one month after the last dose of the study drug.

Who may not be able to join:

• People who are pregnant or breastfeeding, or who become pregnant during the trial.
• People currently receiving any other cancer treatment or participating in another clinical trial, except for a specific type of chemotherapy delivered directly into the spinal fluid for leukaemia where appropriate.
• People who need to take the blood-thinning medication warfarin.
• People with uncontrolled serious health conditions, including active infections, heart failure, unstable chest pain, irregular heart rhythms, or mental health or social circumstances that would make it difficult to follow the study requirements.
• People with an active, untreated infection.
• People with a known active infection with hepatitis A, B, C, or HIV, chronic hepatitis B or C, or HIV infection, or people who are inactive carriers of hepatitis B.
• People who have had an allergic reaction to medicines chemically similar to the study drug (TURALIO®).
• People with blood clotting test results (PT and/or INR) that are 1.5 times or more above the normal range — although people with a specific clotting condition called lupus anticoagulant may still be eligible if cleared by a blood specialist.
• People who have taken certain medications that strongly affect how the body processes the study drug (known as strong CYP3A4 inhibitors or inducers, UGT inhibitors, acid-reducing agents, or proton pump inhibitors) within 14 days or within 5 half-lives of that medication before starting the trial, whichever is longer (confirm with trial site).

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