Phase 2 Pancreatic 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 18 years of age or older
• People who have previously been diagnosed with a solid tumour in the digestive system, such as cancer of the gastrointestinal tract, pancreas, or colon and rectum
• People whose cancer has gone into complete remission after chemotherapy or other anti-cancer treatment, with all cancer-related treatment stopped for at least 12 weeks before joining, no signs of the cancer returning, and no current need for further cancer treatment
• People with persistently low platelet counts (a type of blood cell that helps with clotting) caused by chemotherapy — specifically, a count below 30 x 10⁹/L on two separate blood tests taken at least 7 days apart, or a count slightly above that level but requiring regular platelet transfusions to stay safe
• People whose low platelet count has continued since their last chemotherapy treatment, with no clear signs of natural recovery
• People whose red blood cell count and infection-fighting white blood cell count are largely normal, without significant anaemia or low white cell counts
• People who had a bone marrow test within 1 year of their cancer diagnosis and chemotherapy showing no cancer cells in the marrow, and a normal or higher-than-normal number of platelet-producing cells (megakaryocytes), with or without some maturation problems
• People with no signs of an enlarged liver or spleen, high pressure in the liver's blood supply, or other conditions that might be causing the low platelet count through abnormal redistribution of platelets in the body
• People who have already tried at least one standard medication used to stimulate platelet production (a thrombopoietin receptor agonist or similar drug) for at least 2 weeks at a standard dose, without their platelet count rising to a safe level or to at least twice the starting level
• People who have never previously used the specific study drug Romiplostim N01
• People who have stopped any other platelet-raising medications before joining — other experimental or off-label treatments must have been stopped at least 1 month before enrolment (no waiting period is required for prior thrombopoietin receptor agonists)
• People who are able to understand and sign a consent form and are willing to attend study visits and follow study procedures
• Women who could become pregnant must have a negative pregnancy test before joining and must agree to use effective contraception throughout the study treatment

Who may not be able to join:

• People who have other blood or bone marrow conditions that may affect blood cell production or cause low platelets, such as aplastic anaemia, myelodysplastic syndrome, leukaemia, other blood cancers, or a confirmed history of immune thrombocytopenia (a condition where the immune system attacks platelets)
• People whose underlying cancer has returned or is progressing, or whose bone marrow test shows cancer cells present
• People with an uncontrolled chronic viral infection such as hepatitis B, hepatitis C, or HIV, or a serious active infection at the time of screening or within 4 weeks before screening
• People with serious problems affecting the heart, liver, kidneys, or other organs that would make it unsafe to take part in the study
• People who are pregnant or breastfeeding
• People with a known severe allergic reaction to Romiplostim, Romiplostim N01, ATRA, or any ingredient in the study drugs
• People who have previously had serious side effects from Romiplostim, or for whom Romiplostim did not work
• People who, in the opinion of the study team, may have difficulty completing the treatment or follow-up visits, have a psychiatric or psychological condition that prevents understanding of the study, or have any other condition that could increase risk or affect study results

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