Phase 2 Melanoma 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 aged 18 or older (or adolescents aged 12 and older, with signed assent and parental consent, following institutional guidelines) who agree in writing to take part in the study.
• People in Cohorts 1 and 2 who have an advanced or metastatic solid tumour (including but not limited to melanoma, breast, lung, gastroesophageal, colorectal cancer, sarcoma, or brain tumours) that has grown or spread after standard treatments, did not respond meaningfully to standard treatments, has no available standard treatment, or where the person has chosen not to pursue standard treatment. Gastrointestinal stromal tumour (GIST) is not included.
• People in Cohort 3 who have been newly diagnosed with a specific type of brain tumour called IDH wild-type, MGMT-unmethylated glioblastoma, and who have already completed radiation therapy and chemotherapy with a drug called temozolomide 3 to 8 weeks before starting the study treatment.
• People in Cohorts 1 and 2 who have measurable signs of disease that can be tracked using standard imaging criteria; people in Cohort 3 may have either measurable or non-measurable disease.
• People who have a confirmed genetic mutation in either a gene called CKIT (Cohort 1) or a gene called PDGFRA (Cohort 2), identified through a certified genetic laboratory test; people in Cohort 3 must have a confirmed CKIT or PDGFRA mutation or gene amplification through the same type of test.
• People who have stored tumour tissue available for additional genetic testing related to CKIT or PDGFRA.
• People whose blood counts and organ function (including white blood cells, platelets, haemoglobin, liver enzymes, and kidney function) fall within the acceptable ranges measured within 7 days before starting treatment (confirm specific values with the trial site).
• People whose heart pumping function is above 45%, as measured by a heart scan before the study begins.
• People who are reasonably physically active and able to carry out basic daily activities, rated 0 to 2 on a standard medical scale called the ECOG performance status.
• People with a life expectancy of at least 3 months.
• People who are willing and able to follow all study requirements, including attending scheduled visits and examinations.
• People who are willing to have a tissue biopsy as required by the study.
• Women who are postmenopausal, have had a surgical procedure that prevents pregnancy, or have a negative pregnancy blood test taken within 3 days before starting the study treatment.
• Women of childbearing potential who agree to abstain from heterosexual intercourse or use a highly effective form of contraception throughout the study and for 6 weeks after the last dose.
• Men with female partners who could become pregnant who agree to abstain from sexual intercourse or use a highly effective form of contraception throughout the study and for 30 days after the last dose.

Who may not be able to join:

• People who have gastrointestinal stromal tumour (GIST).
• People who have specific CKIT gene mutations (V654A or T670I) that are known to resist a type of cancer medicine called tyrosine kinase inhibitors.
• People with cancer that has spread to the membranes surrounding the brain or spinal cord, with spinal cord compression, or with brain metastases that are causing symptoms or are not stable. Note: people with stable, symptom-free brain metastases that do not require high or increasing doses of steroid medication may still be considered eligible (confirm with trial site).
• People with a history of a serious heart condition involving reduced heart function (classified as NYHA Class III or IV), or serious heart rhythm problems that require treatment.
• People whose heart's electrical activity shows a prolonged interval on an ECG (specifically a QTcF interval above 470 milliseconds).
• People who are currently taking part in, or have taken part in, another clinical trial or used an experimental medical device within the 2 weeks before starting the study treatment.
• People who have received cancer treatments — including chemotherapy, hormone therapy, immunotherapy, targeted therapy, radiation, or surgery — within the 2 weeks before starting the study treatment, or who have not sufficiently recovered from the side effects of previous treatments.
• People with wounds, ulcers, a hole in the gastrointestinal tract, or bone fractures that are not healing.
• People with a history of a psychotic or serious depressive disorder, unless the condition has been well controlled on stable medication for at least 12 months before joining the study.
• People currently taking certain medications that strongly affect how the body processes drugs (specifically strong CYP3A4 inhibitors or inducers), unless a sufficient washout period has passed (confirm with trial site).
• Women who are pregnant or breastfeeding.
• People who are unable to swallow and keep down oral (tablet or capsule) medications.
• People with stomach or bowel conditions that could significantly affect how the body absorbs the study drug, such as active ulcers, uncontrolled nausea, vomiting, diarrhoea, or previous bowel surgery.
• People who have another cancer that is currently growing or requires active treatment. Note: people with certain skin cancers or cervical cancer in situ that have been treated with the aim of a cure are not excluded.
• People whose overall health, medical history, or test results might interfere with the study results or with their ability to participate safely for the full duration, in the opinion of the treating doctor.
• People in Cohort 3 who have previously received treatment injected directly into the brain, or who have received a drug called bevacizumab.
• People in Cohort 3 who have previously received radiation, chemotherapy, or immunotherapy for a low-grade glioma (a less aggressive form of brain tumour).

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