Phase 2 Brain Cancer Trial, Recruiting

Written by an AI model from the 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 whose cancer has been confirmed by laboratory testing of a tissue or cell sample — either any solid tumour (Group 1) or breast cancer specifically (Group 2).
• People who have at least one measurable brain tumour or brain lesion that is 10mm or larger in size.
• People who have brain lesions that are growing or progressing, which may include lesions not yet treated by surgery or targeted radiation, remaining or growing lesions after surgery, lesions that have been treated with radiation but show clear signs of progression, or lesions previously treated with drug therapy.
• People who are older than 18 years of age.
• People whose general physical condition is rated at a level indicating they are able to carry out basic daily activities (confirmed by a doctor's assessment).
• People whose blood test results show that the liver, kidneys, and bone marrow are functioning within acceptable levels, including blood cell counts, liver enzymes, kidney function, and heart rhythm (QTc below 480ms) — as determined by the trial site.
• People who agree to use reliable contraception (such as hormonal methods, barrier methods, or abstinence) throughout the trial and for six months after finishing treatment, because the effects of the study drug on an unborn child are not known.
• People who are willing and able to understand and sign a consent form.
• People who have stored tumour tissue available from a previous biopsy or surgery (at least one preserved tissue block or 15 unstained tissue slides) for genetic testing.
• People whose tumour shows a specific change in a cell growth pathway involving certain genes (CDK4, CDK6, CCND1, CCND2, CCND3, CCNE1, or CDKN2A), confirmed by an approved laboratory test — this applies to Group 1 only.
• People who also have cancer outside the brain are not excluded on that basis alone.
• People who have been on a stable dose of steroid medication for at least 7 days before joining.
• People who have had Hepatitis B in the past may be eligible if they have been on antiviral treatment for at least 4 weeks and the virus is undetectable in their blood at the time of enrolment.
• People with a history of Hepatitis C may be eligible if the virus is undetectable at screening and they have completed curative antiviral treatment at least 4 weeks before enrolment.

Who may not be able to join:

• People who have previously been treated with a type of drug called a CDK4/6 inhibitor.
• People who have received chemotherapy, immunotherapy, or radiation within the 2 weeks before joining (or 6 weeks for certain specific chemotherapy types), or who still have significant side effects from earlier treatment.
• People who are currently taking part in another clinical trial using an experimental treatment.
• People who are currently receiving other chemotherapy or immunotherapy treatments for their cancer, with some specific exceptions (such as certain hormone therapies, bone-strengthening drugs, or targeted breast cancer treatments — confirm with trial site).
• People whose cancer has spread to the lining of the brain or spinal cord — this applies to Group 1 only; people in Group 2 may still be eligible (confirm with trial site).
• People who have had a serious allergic reaction to drugs chemically similar to the study drug (including a related drug called abemaciclib).
• People who are taking certain medications that affect how the body breaks down drugs through a specific liver enzyme pathway known as CYP3A — the trial site will assess which medications are affected.
• People who have serious uncontrolled health conditions such as an active infection, heart failure, unstable chest pain, heart rhythm problems, or mental health or personal circumstances that would make it difficult to follow the trial requirements.
• People who are pregnant or breastfeeding, because the effects of the study drug on a developing baby or infant are unknown.
• People who are HIV-positive and taking combination antiretroviral therapy are not eligible for Group 1 due to possible drug interactions and infection risk; people in Group 2 who are HIV-positive are not permitted to join.
• People who are currently taking medications known to affect heart rhythm (specifically those that prolong the QT interval).
• People who are unable to have MRI scans.
• People whose heart rhythm measurement (QTc) is above 480ms, or who have a personal or family history of certain heart rhythm conditions (long or short QTc, or Torsade de Pointes).
• People who have uncontrolled abnormal levels of certain minerals in the blood (such as calcium, potassium, or magnesium) that can affect heart rhythm.
• People with an active autoimmune disease — this applies to Group 2 only.
• People who have previously had radiation treatment to the lungs — this applies to Group 2 only.
• People who have previously been treated with certain immunotherapy drugs that target PD-1 or PD-L1 — this applies to Group 2 only.
• People who have had an organ or tissue transplant from another person (allogeneic transplant).
• People who have a history of lung inflammation (pneumonitis) or scarring (interstitial lung disease) that required steroid treatment, or who currently have these conditions.
• People with a known history of Hepatitis B or a currently active Hepatitis C infection.

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