Phase 2 Stomach 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 have been diagnosed (confirmed by laboratory testing of tissue or cells) with stomach cancer or cancer of the gastroesophageal junction (the area where the stomach meets the food pipe) that has spread to other parts of the body, or that cannot be removed by surgery.
• People whose treating doctor determines they are medically suitable to receive the combination of two cancer medicines: ramucirumab and paclitaxel.
• People whose cancer has gotten worse or spread after previous treatment, following one of several specific treatment history patterns — for example, cancer that progressed during or shortly after first-line treatment for advanced disease, or cancer that progressed during or after earlier preventative (adjuvant or neo-adjuvant) treatment (confirm with trial site for which history applies).
• People whose cancer can be measured on a CT scan according to standard measurement guidelines (RECIST v1.1).
• People who are in relatively good general health, rated 0 or 1 on a standard medical scale where 0 means fully active and 1 means slightly limited (ECOG Performance Status).
• People with a life expectancy of at least 3 months.
• People aged 18 or older (in the US and Japan) or 19 or older (in South Korea).
• People who have signed a written consent form approved by an ethics review board.
• People whose blood tests show their organs (such as kidneys and liver) are functioning adequately, based on tests done within 14 days before starting the trial.
• People who are able to have children and agree to use effective contraception throughout the study and for 6 months after the last dose of the study drug (TRK-950).
• People whose tumour tissue can be tested at an approved laboratory for a specific protein called CAPRIN-1, and whose tissue meets or exceeds a defined level of that protein (at least 30% of cells staining at a certain intensity) — all participants must sign a separate consent for this pre-screening test.

Who may not be able to join:

• People who have previously been treated with ramucirumab or paclitaxel.
• People whose stomach or gastroesophageal junction cancer tests positive for a protein called HER2.
• People who have had major surgery within 28 days before joining the trial.
• People with certain abnormal heart electrical readings (QTc interval above specific thresholds) measured before starting the trial.
• People with moderate to severe heart failure (NYHA Class II–IV) or poorly controlled abnormal heart rhythms.
• People who have had a serious blood clot in an artery — such as a heart attack, unstable chest pain, stroke, or mini-stroke — within the 3 months before joining.
• People who have a history of lung inflammation (pneumonitis) that required steroid treatment, or who currently have pneumonitis.
• People who have a clinically significant blood clot in a vein, or who are currently taking blood-thinning (anticoagulant) medicines (though people on low-dose preventative anticoagulation may still be eligible if their blood test results meet the required standard — confirm with trial site).
• People with high blood pressure that remains at or above 150/90 mmHg despite standard medical treatment.
• People with active, uncontrolled infections (bacterial, viral, or fungal) that require systemic treatment.
• People who are pregnant or breastfeeding.
• People who have received radiation therapy within 2 weeks, or chemotherapy, immunotherapy, targeted therapy, or another investigational treatment within 4 weeks before joining (or within 2 weeks for certain oral chemotherapy drugs, such as S1 or capecitabine).
• People who have significant bleeding disorders, blood vessel inflammation (vasculitis), or who have had a significant bleed from the gastrointestinal tract within the past 3 months.
• People with significant fluid build-up in the abdomen (ascites), who have had a procedure to drain that fluid in the last 3 months, or who regularly need such drainage procedures.
• People who have had a hole (perforation) or abnormal channel (fistula) form in their gastrointestinal tract within the past 6 months.
• People who have a wound that is not healing, a stomach ulcer, or a bone fracture within 28 days before joining.
• People who have a bowel blockage, certain inflammatory bowel conditions (such as Crohn's disease or ulcerative colitis), a history of extensive bowel removal surgery with ongoing diarrhoea, or chronic diarrhoea.
• People with a currently active HIV, hepatitis B, or hepatitis C infection (people with a past history of hepatitis B or C may still be eligible if the virus is undetectable in their blood — confirm with trial site).
• People who are currently taking part in another clinical trial involving an unapproved drug or treatment, unless the last dose of that trial drug was at least 28 days before joining this trial (people in surveys or observational studies are generally still eligible — confirm with trial site).

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