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 who have voluntarily agreed to take part and are willing and able to complete all parts of the trial
• People aged 18 or older, of any gender
• People with one of the following cancer types and situations:
  • Group 1: Epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer at an advanced or spread stage (FIGO stage III–IV), who have previously been treated with platinum-based chemotherapy and whose cancer got worse or came back during treatment or within about 6 months after finishing it
  • Group 2: Limited-stage small cell lung cancer (as defined by a specific medical staging system) where surgery is not an option, and the cancer has not gotten worse during or after at least 4 cycles of platinum-based chemotherapy combined with radiation therapy, with that treatment completed within 6 weeks before starting the trial
  • Group 3: Other solid tumour cancers that have not responded to standard treatments, have no standard treatment options available, or for whom standard treatment is not currently suitable
• People in Group 1 whose cancer has a measurable area visible on scans, and who have had debulking surgery at some point; prior treatment with bevacizumab or PARP inhibitors is permitted
• People in Group 2 whose chemotherapy included platinum agents and intravenous etoposide, followed by a full course of radiation therapy
• People in Groups 1 and 3 who have at least one area of cancer that can be measured on a scan according to standard medical criteria (RECIST 1.1)
• People whose general physical functioning is rated as 0 or 1 on a standard medical scale (meaning fully active or able to carry out light activity)
• People with an expected survival of at least 3 months
• People whose blood, liver, kidney, clotting, and heart function results from recent tests fall within the required ranges, without having had blood transfusions or certain blood-boosting treatments in the 14 days before testing
• People who agree to use effective contraception from the time of signing consent until 3 months after the last dose; women who could become pregnant must have a negative pregnancy blood test before the first dose

Who may not be able to join:

• People who received chemotherapy, radiation, immunotherapy, biological therapy, hormonal therapy, or other anti-cancer treatments within 4 weeks (or 5 half-lives, whichever is shorter) before the first dose, with some specific exceptions for certain drug types with different timeframes
• People who took part in another clinical trial or received an experimental treatment within 4 weeks before the first dose
• People who had major surgery (not including biopsy) or a serious injury within 4 weeks before the first dose, or who are expected to need planned surgery during the trial
• People who used certain specific medications that strongly affect how the body processes drugs (strong CYP3A4, CYP1A2, or CYP2D6 inhibitors or inducers) within 14 days or 5 half-lives before the first dose
• People who have previously had a bone marrow or stem cell transplant from a donor, or a solid organ transplant, or who are currently taking immunosuppressive or anti-rejection medications
• People with a known allergy to any ingredient in the study drug
• People who still have side effects from previous cancer treatment that have not improved to a mild level (with some exceptions, such as hair loss, mild nerve-related symptoms, or managed thyroid conditions)
• People with active hepatitis B or C infection, a positive HIV test, or a positive syphilis test
• People who have or have previously had cancer that has spread to the brain or the lining around the brain or spinal cord
• People with large, uncontrolled fluid build-up in the chest or abdomen, as determined by the treating doctor
• People with serious heart conditions, including: dangerous heart rhythm problems; a recent (within 6 months) heart attack, heart failure, stroke, or similar serious heart event; moderate-to-severe heart failure by standard classification; blood pressure that remains high despite treatment (at or above 140/90 mmHg); or any condition or medication that increases the risk of a specific heart rhythm problem called QT prolongation
• People with an active infection requiring treatment with systemic medication within 4 weeks before the first dose
• People with active flare-ups of certain gut conditions (such as Crohn's disease, ulcerative colitis, or short bowel syndrome) that could affect how the drug is absorbed
• People with interstitial lung disease, pulmonary fibrosis, or drug-induced lung inflammation (radiation-related lung inflammation is an exception)
• People with other serious conditions affecting the liver, kidneys, nervous system, mental health, hormones, blood, or immune system that could interfere with participation, as judged by the treating doctor
• People who have had another type of cancer in the past 5 years, except for certain fully cured skin cancers or cervical cancer in situ
• People with known alcohol or drug dependence
• People with psychiatric conditions or who are unlikely to be able to follow the trial requirements
• People who are pregnant or breastfeeding
• People who have any other medical or personal circumstances that the treating doctor considers unsuitable for participation

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