Phase 1 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:

• Adults aged 18 or older who have been diagnosed with advanced or returning solid tumour cancer, where no other standard treatments are known to be helpful.
• People who are generally well enough to carry out light activity and care for themselves (measured by a standard health scale called ECOG, with a score of 0 or 1).
• People who are willing to have a small tissue sample (biopsy) taken before treatment begins, and after completing the first treatment cycle.
• For the expansion phase of the trial: people whose ovarian, peritoneal, fallopian tube, or endometrial cancer has returned or persisted, and for whom a single-drug treatment using paclitaxel would be considered a reasonable option by their doctor.
• People with certain types of endometrial cancer, including endometrioid, serous, clear cell, mucinous, squamous cell, transitional cell, undifferentiated, mixed, mesonephric, or other specified forms of adenocarcinoma.
• People with certain types of ovarian cancer, including high-grade serous, endometrioid, clear cell, squamous, transitional cell (Brenner), mixed, or undifferentiated carcinoma.
• People whose doctor estimates they have a life expectancy of more than 3 months.
• People who have at least one tumour that can be measured using standard imaging tools (such as CT or MRI), and where that tumour can also be biopsied.
• People whose blood, liver, kidney, nerve function, and blood clotting results meet the required healthy levels (confirm specific values with the trial site).
• People who have previously been treated with a chemotherapy drug called docetaxel, regardless of how they responded to it.
• For the expansion phase: people who previously received paclitaxel and did not have their cancer progress during treatment, or did not relapse within 6 months of finishing it.
• People who are free from active infections needing antibiotics, except for a straightforward urinary tract infection.
• People whose hormone therapy targeting the cancer has been stopped at least two weeks before starting this trial's treatment (hormone replacement therapy may continue, and stable hormone treatments for prostate, ovarian, or breast cancer are permitted).
• People whose other cancer treatments, including immunotherapy, have been stopped at least four weeks before starting this trial (six weeks for certain specific chemotherapy drugs).
• Women who could become pregnant must have a negative pregnancy test within 24 hours before starting treatment, and must agree to use an accepted form of contraception throughout the study and for at least 6 months after the last dose (women who are post-menopausal or have been surgically sterilised are not required to have a pregnancy test).
• Male participants must agree to use an accepted form of contraception for the duration of the study.
• People who are willing and able to give written consent to participate.

Who may not be able to join:

• For the expansion phase: people with low-grade serous ovarian cancer or mucinous ovarian cancer.
• For the expansion phase: people who have recently taken certain medications that strongly affect how the body processes drugs (CYP3A4 and CYP2C8 interactions) — a waiting period of at least two weeks is required before starting treatment (confirm specific medications with the trial site).
• People who have previously had a bone marrow or stem cell transplant.
• People who are currently taking part in another clinical trial involving an experimental treatment.
• Women who are pregnant or breastfeeding.
• People with a history of brain tumours, brain metastases (cancer that has spread to the brain), seizures not controlled by standard medication, or those who have had a stroke or related brain blood vessel event within the past 6 months.
• People who have had a heart attack, unstable chest pain, heart or artery bypass surgery, stroke, or a mini-stroke (TIA) within the past 6 months.
• People with serious or uncontrolled heart conditions, such as severe heart failure, uncontrolled high blood pressure, significant heart rhythm problems, or certain abnormal heart test (ECG) results.
• People with an active build-up of fluid around the lungs or heart that is causing symptoms (treated and resolved fluid may be acceptable).
• People who are unable to have an MRI scan — for example, due to claustrophobia, certain types of metal implants such as pacemakers, or a known allergy to the contrast dye used in MRI scans.
• People who have a condition that, in the investigator's opinion, makes participation in the trial unsuitable.
• People who have had a severe allergic reaction (Grade 3 or higher) to paclitaxel, docetaxel, or certain substances used in their preparation.
• People who still have significant side effects (above a mild level) from previous cancer treatments, not including hair loss.
• People whose substance use, mental health, or personal circumstances might interfere with their ability to take part fully in the study.
• People living with HIV who have a low immune cell count (CD4+ below 350 cells/mcL), or people with currently active hepatitis B or C infection.
• People who have had major surgery, an open biopsy, dental surgery leaving an open wound, or a significant injury within the 28 days before starting treatment, or who are expected to need major surgery during the study; also people who have had a vascular access device placed or a core biopsy within 7 days before registration.
• For the expansion phase: people who are not able to receive paclitaxel as a treatment for their cancer.

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