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:

• Adults aged 18 and over who have a solid tumour cancer confirmed by laboratory testing of a tissue or cell sample (Phase IA), OR adults with confirmed pancreatic, colorectal, or breast cancer (Phase IB).
• Young people aged 12 to under 18 with a confirmed solid tumour cancer — except certain types of rhabdomyosarcoma (a specific muscle cancer), including its embryonal, alveolar, spindle cell/sclerosing, and pleomorphic forms (Phase IB).
• People whose cancer cannot be fully removed by surgery, has spread to at least one other part of the body beyond where it started (or has come back after the original tumour was removed), and has at least one area that can be measured on scans.
• People whose cancer continued to grow during or after at least one standard chemotherapy treatment (Phase IA and IB1), or for whom no standard treatment options remain available (Phase IB2).
• People who have recovered from side effects of previous treatments or surgery to a mild level or better before joining.
• People with a general health and functioning score of at least 70% on standard medical scales used for this age group.
• People whose blood counts meet minimum levels — including sufficient white blood cells, platelets, and haemoglobin — as confirmed by blood tests.
• People whose blood clotting levels fall within the ranges specified by the trial (with some allowance for those already taking blood-thinning medications for an approved medical reason).
• People whose liver function blood test results fall within the acceptable ranges set by the trial.
• People whose kidney function falls within the acceptable ranges set by the trial.
• People who are able and willing to use reliable contraception (hormonal, barrier method, or abstinence) before, during, and for 120 days after the trial treatment — this applies to people who could become pregnant and to people who could father a child.
• People who are currently breastfeeding must be willing to stop breastfeeding when treatment begins.
• People who weigh at least 35 kg (approximately 77 pounds).
• People (or, for younger participants, their parent or guardian) who are willing and able to read and sign a written consent form.
• People who have at least one tumour area that can be safely biopsied (separate from the one used to measure the disease) and who are willing to have these biopsies done (Cohort IB1 only).
• People who are able to swallow oral capsules.

Who may not be able to join:

• People who have had certain cancer treatments too recently before the trial starts, including minor procedures (within 14 days), major surgery or curative radiation (within 28 days), palliative radiation (within 14 days), chemotherapy or experimental drugs with a short half-life (within 14 days), or longer-acting experimental drugs or certain chemotherapy types including platinum-based or alkylating agents (within 28 days).
• People taking certain medications that strongly or moderately affect how the body processes drugs (specifically, moderate or strong CYP3A4 inhibitors or inducers), who are unable to safely stop those medications before treatment begins.
• People diagnosed with certain heart conditions within the 6 months before starting treatment, including specific types of heart muscle disease, abnormal heart pumping function below set thresholds, severely damaged heart valves, a resting heart rate from atrial fibrillation above 100 beats per minute, a specific electrical heart measurement (QTcF) at or above 480 milliseconds in adults or 460 milliseconds in those aged 12 to under 18, or other factors that raise the risk of abnormal heart rhythms (confirm with trial site).
• People who are HIV, hepatitis C, or hepatitis B positive and are currently taking antiviral medications.
• People who have had a different cancer diagnosis within the past 3 years — though people with a history of certain early-stage or non-invasive cancers (such as cervical carcinoma in situ, superficial bladder cancer, or skin cancers) previously treated with curative intent are not automatically excluded (confirm with trial site).
• People whose cancer is progressing very rapidly in a way that, in the treating doctor's judgement, may make it unsafe to participate.
• People who have cancer that has spread to the brain or spinal cord, or who have certain nervous system conditions that could increase risk — such as a stroke within the past 3 months or active brain infection.
• People with significant active or ongoing infections, including tuberculosis with active symptoms.
• People with any history of seizures, or whose screening brain wave test (EEG) shows patterns associated with increased seizure risk.
• People with other serious or uncontrolled medical conditions that, in the treating doctor's judgement, could affect their ability to safely participate.
• People who have had gastric bypass surgery, who receive nutrition through a feeding tube or intravenously, or who have conditions affecting the body's ability to absorb food or medication (such as coeliac disease, Crohn's disease, chronic pancreatitis, cystic fibrosis, or intestinal damage). People with severe, ongoing nausea and vomiting are also excluded. (Note: people with gastric banding — as opposed to gastric bypass — are not automatically excluded.)
• People who are pregnant.

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