Phase 1 Ovarian 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:

• Adults aged 18 or older who are willing and able to give written consent to participate.
• People with advanced solid tumours that have been confirmed by laboratory testing of tissue or cell samples, including specific tumour types depending on which part of the trial is relevant (confirm with trial site for which tumour types apply to each part).
• People whose cancer has specific genetic changes (such as in KEAP1, NFE2L2, STK11, NF1, PIK3CA, AKT, PTEN, or ARID1A genes), or whose tumour has low levels of a protein called ASNS — depending on which part of the trial is being considered.
• People with certain specific cancer types, which may include: ovarian cancer (high-grade, non-mucinous, platinum-resistant, returning cancer), head and neck cancer after platinum-based treatment, chondrosarcoma, melanoma previously treated with immunotherapy, or non-small cell lung cancer — depending on which part of the trial applies.
• People who have already received at least one prior treatment for their advanced cancer and whose cancer has not responded to, or who are not suitable for, currently available treatments.
• People who have finished previous cancer treatments (chemotherapy, radiotherapy, immunotherapy, or experimental therapies) at least 3 weeks before starting the study drug, and whose side effects from those treatments have mostly resolved.
• People who can provide tumour tissue samples (either stored samples from previous biopsies or a new biopsy) for genetic and biomarker testing — for ovarian cancer patients, a fresh biopsy is required in addition to stored tissue, provided this can be done safely.
• People who have at least one tumour that can be measured or assessed using CT or MRI scans.
• People who are in reasonably good general health and able to carry out daily activities, as assessed using a standard scale (ECOG score of 0 or 1), with no worsening in the two weeks before starting the trial.
• People whose blood test results show that the kidneys, liver, blood counts, and heart are functioning adequately as defined by the trial's laboratory thresholds.
• People whose heart is pumping effectively, with a pumping function (left ventricular ejection fraction) of at least 50%.
• Women who cannot become pregnant — either because of surgery (removal of the uterus, both ovaries, or both fallopian tubes) or because they are post-menopausal (no periods for 2 or more years, or confirmed by a hormone test).
• Women who could become pregnant but who agree to use a highly effective form of contraception combined with a barrier method (such as a condom) from before starting the trial until at least 4 weeks after the last dose, and who have a negative pregnancy test at screening and are not breastfeeding.
• Men who are not sterile and who plan to be sexually active with a woman who could become pregnant, and who agree to use a condom from the start of the trial until at least 16 weeks after the last dose, or to practise complete abstinence for the full duration of treatment and for at least 3 months after the last dose.

Who may not be able to join:

• People who have had another cancer diagnosed within the past 2 years, unless it was a type that has been successfully treated and is considered curable (such as certain skin cancers or early-stage cancers confined to one area).
• People with cancer that started in the brain, or who have brain metastases that are causing symptoms — though people with previously treated and stable brain metastases that have resolved may be considered (confirm with trial site).
• People with serious heart problems, including unstable heart rhythm in the past 6 months, a significantly prolonged heart electrical interval (QTcF above 450ms for men or 470ms for women), or a history of heart attack, stenting, bypass surgery, unstable chest pain, severe peripheral blood vessel disease, or significant heart failure within the past 6 months.
• People who have had major surgery within 28 days before starting the study drug, or who are expected to need major surgery during the trial.
• People with significant ongoing or recent infections.
• People with a psychiatric condition that would prevent them from understanding and giving informed consent.
• People who have recently taken certain medications that strongly affect how the body processes drugs (strong CYP3A4 inducers or inhibitors, including grapefruit juice, within 2 weeks; St John's Wort within 3 weeks; enzalutamide within 4 weeks before starting treatment).
• People who have recently taken certain other medications that interact with specific liver enzymes involved in drug processing (strong CYP2D6 inhibitors or sensitive CYP3A4 substrates within 7 days before the first dose).
• People who have had radiotherapy within 4 weeks before starting the study drug (radiotherapy for symptom relief is acceptable if completed at least 2 weeks before starting and no further radiotherapy to the same area is planned).
• People with serious uncontrolled medical conditions — such as uncontrolled high blood pressure, a history of kidney transplant, or active bleeding disorders — that the study doctor believes would make participation unsafe.
• People with a known allergy to drugs that are chemically similar to those being studied.
• People with a known history of alcohol or drug abuse.
• People who do not have the legal capacity to give informed consent.
• People who cannot swallow tablets or capsules whole, or who have ongoing digestive conditions (such as severe nausea, chronic gut disease, or major bowel surgery) that could prevent the study drugs from being properly absorbed.
• People who are unwilling to follow the requirements of the trial.
• People with any other condition, finding, or laboratory result that the study doctor believes would make participation unsafe or affect the reliability of the results.

Additional criteria that apply only to Part B of the trial:

• People with a severe allergy to monoclonal antibodies, a history of severe allergic reactions (anaphylaxis), or poorly controlled asthma may not be able to join.
• People with a known allergy to paclitaxel or bevacizumab (drugs used in Part B) may not be able to join.
• People with a history of bowel obstruction, abdominal fistula, bowel perforation, or internal abdominal abscesses, or with signs of bowel involvement on examination or scans, may not be able to join.
• People with a significant amount of protein in their urine at the time of screening may not be able to join (confirm threshold with trial site).
• People at increased risk of bleeding — for example, due to recent major injury or surgery, a history of bleeding stroke, or significant bleeding within the past 3 months — may not be able to join.
• People with significant heart or blood vessel problems within the past 6 months may not be able to join.
• People who already have significant nerve damage in their hands or feet (peripheral neuropathy of Grade 2 or above) may not be able to join.
• People who needed fluid drained from their abdomen (paracentesis) in the 2 weeks before enrolment may not be able to join.

Additional criteria that apply only to Part C of the trial:

• People who have had another cancer within the past 5 years (with some exceptions for certain low-risk, fully treated skin cancers) may not be able to join.
• People with a known allergy to capivasertib (a drug used in Part C) may not be able to join.
• People with diabetes (Type 1 or Type 2) or with poorly controlled blood sugar levels (HbA1c above 8%) may not be able to join.
• People with serious liver disease or significantly abnormal liver function test results at screening may not be able to join.
• People with ongoing side effects from previous cancer treatments that are still at a significant level (Grade 2 or above), apart from hair loss, may not be able to join — though exceptions may be made in consultation with the study team.
• People with cancer that has spread to compress the spinal cord or the membranes around the brain or spinal cord, if this still requires steroid treatment, may not be able to join.
• People with significant heart problems or abnormal heart rhythms, severely low blood pressure, or a heart pumping function below 50% may not be able to join.
• People with active tuberculosis may not be able to join.
• People with active hepatitis B or C infection may not be able to join.
• People with HIV where the virus is not well controlled or the immune system is significantly weakened may not be able to join — though some exceptions may be possible depending on individual circumstances (confirm with trial site).
• People whose HIV treatment involves certain medications that interact with capivasertib may not be able to join.
• People who are currently receiving other cancer treatments or medications that could interfere with the study drugs may not be able to join.
• People who have had radiotherapy to a large area of bone marrow within 4 weeks, or palliative radiotherapy within 2 weeks, before starting the study may not be able to join.

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