Phase 2 Ovarian 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 aged 18 years or older.
• People who have previously been diagnosed with certain gynaecologic, breast, or lung cancers — including but not limited to non-small cell lung cancer, ovarian cancer, breast cancer, endometrial cancer, cervical cancer, fallopian tube cancer, primary peritoneal cancer, or other lung cancers (confirm with trial site for other tumour types).
• People whose cancer is in complete remission after chemotherapy or other anti-cancer treatment, with that treatment stopped for at least 12 weeks before joining, no signs of the cancer returning, and no current need for further cancer-directed treatment.
• People with persistently low platelet counts caused by chemotherapy — either a platelet count below 30 x 10⁹/L on two separate blood tests taken at least 7 days apart, or a slightly higher count but with a need for platelet transfusions to keep platelet levels safe.
• People whose low platelet count has continued since their last chemotherapy treatment, with no clear sign of natural recovery.
• People whose red blood cell count and neutrophil (infection-fighting cell) count are generally within acceptable ranges, without significant anaemia or low white blood cell levels.
• People who have had a bone marrow assessment within 1 year of their cancer diagnosis and chemotherapy, showing no cancer cells in the bone marrow and a normal or higher-than-normal number of platelet-producing cells (megakaryocytes).
• People with no signs of an enlarged liver or spleen, high pressure in the portal vein, or other conditions suggesting the low platelet count is mainly caused by platelets pooling abnormally in the body.
• People who have already tried at least one medication from a class of platelet-boosting treatments (thrombopoietin receptor agonists or recombinant human thrombopoietin) for their chemotherapy-related low platelet count, without a meaningful response after at least 2 weeks of standard dosing.
• People who have not previously been treated with a specific drug called Romiplostim N01.
• People who have stopped all other platelet-raising medications before enrolling — no waiting period is required after stopping thrombopoietin receptor agonists, but other investigational or off-label treatments must have been stopped for at least 1 month before joining.
• People who are able to understand and sign a consent form and are willing to attend study visits and follow study procedures.
• People of reproductive potential who agree to use effective contraception during the study treatment; women who could become pregnant must have a negative pregnancy test before enrolling.

Who may not be able to join:

• People with other blood or bone marrow disorders that may affect blood cell production or cause low platelet counts — such as aplastic anaemia, myelodysplastic syndrome, leukaemia, other blood cancers, or a confirmed history of primary immune thrombocytopenia (ITP).
• People whose underlying cancer is currently returning or progressing, or whose bone marrow examination shows cancer cells present.
• People with an uncontrolled ongoing 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 severe heart, liver, kidney, or other organ problems, or any serious medical condition that would make tolerating the study treatment unsafe.
• People who are currently pregnant or breastfeeding.
• People with a known serious allergic reaction to Romiplostim, Romiplostim N01, ATRA, or any ingredient in the study medications.
• People who have previously had a severe side effect from Romiplostim, or for whom Romiplostim did not work.
• People whose ability to complete treatment or follow-up may be significantly limited — including due to a psychiatric or psychological condition that prevents understanding of the study, or any other condition that the trial investigator considers may increase risk or affect the reliability of study results.

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