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:

• People who have been fully informed about the study and have signed a consent form agreeing to take part.
• Adults aged 18 or older.
• People with certain advanced or spreading cancers that have been confirmed by laboratory testing of tissue samples, including specific types depending on the phase of the trial:
  • In the earlier phase (Phase 1a): people with advanced or spreading salivary gland, bladder, ovarian, or breast cancer whose cancer has grown or returned after standard treatment, or who cannot tolerate standard treatment; or people with soft-tissue sarcoma who have not yet received chemotherapy for advanced disease, or who stopped a chemotherapy drug called doxorubicin early due to side effects.
  • In the later phase (Phase 1b): people with specific types of high-grade soft-tissue sarcoma (dedifferentiated liposarcoma or undifferentiated pleomorphic sarcoma), salivary gland cancer, or triple-negative breast cancer that is locally advanced or has spread, who have received a limited number of prior treatments as specified for each cancer type.
• In Phase 1b, people whose cancer has been shown by scans to have grown in the six months before joining the trial (unless the cancer is newly diagnosed or newly spread).
• In Phase 1b, people who have at least one area of cancer that can be measured on scans, as defined by standard criteria called RECIST.
• People whose doctors estimate they have a life expectancy of at least 12 weeks.
• People who are in good enough general health to carry out normal daily activities with little or no limitation, as rated on a standard scale called ECOG Performance Status 0 or 1.
• People who have recovered from most side effects of any previous cancer treatment, with only mild or no remaining effects (with slightly more flexibility allowed for hair loss and nerve-related symptoms).
• People whose blood test results show adequate bone marrow, liver, and kidney function, as measured within ranges specified by the trial.
• Women who could become pregnant must have a negative pregnancy blood test within 7 days before starting the trial drug.
• People who agree to use highly effective contraception during the trial and for at least 6 months after the last dose; male participants must also agree not to donate sperm during this period.
• People who have suitable veins or a central line that the trial doctor considers appropriate for receiving the study drug by drip infusion.
• People who are willing and able to follow the trial schedule, including blood tests and return visits to the hospital.

Who may not be able to join:

• People who have received a cancer treatment called trastuzumab (Herceptin) within 7 months before the planned start of the trial drug.
• People who have previously received a total lifetime dose of doxorubicin or an equivalent chemotherapy drug at or above a specified high level (350 mg/m²).
• People who have active or untreated cancer that has spread to the brain or the lining of the brain and requires treatment.
• People who have had another active cancer requiring treatment within the past 2 years, with some exceptions such as certain skin cancers, early-stage prostate cancer with normal markers, or non-invasive (in-situ) cancers.
• People who have a serious uncontrolled illness that could affect their ability to follow the trial requirements.
• People with significant heart problems, including very high blood pressure that is not controlled, unstable chest pain, moderate-to-severe heart failure, reduced heart pumping function, a serious abnormal heart rhythm requiring treatment, or a heart attack within the past 6 months, as assessed by the trial doctor.
• People with certain abnormal heart electrical readings on an ECG, or factors that increase the risk of dangerous heart rhythm problems (confirm with trial site).
• People with HIV who have had a serious HIV-related infection within the past 12 months, or whose HIV is not stably controlled on medication.
• People with active hepatitis B or hepatitis C infection that is untreated or not adequately controlled, as defined by specific blood test criteria.
• People who have had a serious infection requiring intravenous antibiotics within 21 days before the planned start of the trial drug.
• People with any other significant active health condition that the trial doctor believes would make it unsafe to receive an experimental drug.

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