Phase 2 Brain Cancer 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 are older than 18 years of age.
• People whose general health and ability to carry out daily activities falls within an acceptable range, as measured by a standard medical scoring system called ECOG PS (scores 0–2) (confirm with trial site).
• People who are expected to live for at least 3 months or more.
• People who have brain metastasis (cancer that has spread to the brain) confirmed by MRI scan, with at least one measurable brain lesion that has not previously been treated with radiotherapy.
• People who have been using mannitol or hormone (steroid) therapy for brain metastasis before joining, provided the dose has been stable for at least one week and does not need to be increased.
• People whose organs (such as liver and kidneys) and bone marrow are functioning adequately.
• People who have recovered from most side effects of previous cancer treatments, with any remaining side effects being mild (grade 1 or lower), except for hair loss or skin darkening.
• People who are willing to participate, able to sign a written consent form, and willing to attend follow-up appointments as required.

Who may not be able to join:

• People who have cancer that has spread to the lining of the brain or spinal cord (leptomeningeal metastasis), or who have cyst-like tumour lesions in the brain, as confirmed by MRI or spinal fluid testing.
• People who have significant fluid build-up in body cavities (such as the abdomen, around the lungs, or around the heart) that is not being well managed by treatments such as drainage.
• People who have serious brain-related complications needing urgent treatment, or brain metastasis symptoms (such as very high pressure in the skull, mental disturbance, or seizures) that are not adequately controlled by steroids or other therapies.
• People who have previously received bevacizumab or a type of drug called EGFR-TKI, unless: the cancer did not progress while on those treatments, AND it has been more than 3 months since those treatments were stopped before the cancer progressed (confirm with trial site).
• People who have received whole-brain radiotherapy, chemotherapy, or surgery within 2 weeks before the first dose of the study treatment; or trastuzumab-based therapy or hormone therapy within 1 week before the first dose; or radiotherapy for bone metastases within 2 weeks before the first dose.
• People who have a known, significant lung disease that seriously affects breathing — such as idiopathic pulmonary fibrosis or lung inflammation (pneumonitis) — or who have previously had a severe (grade 3 or higher) form of interstitial lung disease.
• People who have taken full-dose blood-thinning or clot-dissolving medications within 10 days before joining, or anti-inflammatory drugs that affect platelets (with the exception of low-dose aspirin of 325mg or less per day for prevention).
• People who have unhealed wounds, active stomach ulcers, or other conditions that may increase the risk of bleeding — including major surgery within the past 4 weeks, a blood clot event (in an artery or vein) within the past year, or a previous stroke.
• People who have a known inherited tendency to bleed or a blood clotting disorder.
• People who have participated in another clinical drug trial within 2 weeks before joining.
• People who are receiving other cancer treatments at the same time as this study, except for bone-strengthening medications (bisphosphonates) used for bone metastasis or osteoporosis.
• People who have had another type of cancer in the past 5 years, unless it was fully treated with no sign of disease for at least the past 3 years — exceptions may apply for certain skin cancers or cervical cancer in situ that were fully cured (confirm with trial site).
• People who have heart problems, including heart failure, a past full-thickness heart attack, chest pain requiring medication, significant heart valve problems, serious heart rhythm abnormalities, or an abnormal heart electrical reading (QTc above 450ms for men or above 470ms for women) at rest.
• People with uncontrolled high blood pressure (resting systolic pressure above 160mmHg or diastolic pressure above 100mmHg).
• People with certain other health conditions, including: a known weakened immune system (including HIV), a history of organ transplantation, active or significant hepatitis B or C infection, syphilis, known allergy to the study drug or its ingredients, or a serious infection currently needing antibiotic, antiviral, or antifungal treatment.
• People who are pregnant, breastfeeding, have a positive pregnancy test, or are not willing to use effective contraception throughout the study.
• People who are unable to swallow, have a bowel obstruction, or have any other condition that would affect taking or absorbing the study medication.
• People who, in the opinion of the trial doctor, have any other condition that makes participation in the study inappropriate.

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