NCT01478685

Who might be able to join this trial:

• You are a man or woman aged 18 or older
• You are willing and able to understand and sign a consent form before any study procedures begin
• You are able to attend all required study visits and follow the study schedule
• You have been diagnosed with an advanced solid tumor cancer (confirmed by tissue or cell testing) that cannot be surgically removed, and either your cancer got worse on standard treatment, you could not tolerate standard treatment, no other effective treatment exists, or you have chosen not to have standard treatment
• You are willing to have a tumor biopsy taken for screening purposes (optional in the first part of the study, required in the second part)
• You are reasonably active and able to care for yourself — not completely disabled (confirm with trial site)
• Your blood counts, kidney function, liver function, and potassium levels meet certain minimum requirements based on recent lab tests (confirm specific values with trial site)
• If you are a woman who could become pregnant, you must have a negative pregnancy test within 7 days before starting treatment
• If you are a woman who could become pregnant, you must agree to use an approved form of birth control during the study and for 3 months after your last dose
• If you are a man with a female partner who could become pregnant, you must agree to use an approved form of birth control throughout the study and for 6 months after your last dose

For the second part of the study only, additional requirements include:

• Your cancer is one of the specific types listed for each treatment group:
  • Group A (CC-486 plus carboplatin): bladder or urinary tract cancer, or ovarian, fallopian tube, or peritoneal cancer that has come back or stopped responding to treatment
  • Group B (CC-486 plus albumin-bound paclitaxel): non-small cell lung cancer or pancreatic cancer that has come back or stopped responding to treatment
  • Group C (CC-486 alone): cancers linked to certain viruses, including nasopharyngeal cancer, cervical cancer, anal cancer, or Merkel cell skin cancer — note that liver cancers linked to hepatitis B or C are not eligible; head and neck squamous cell cancers must be confirmed HPV-positive to be eligible
• If your cancer has spread to the liver, your blood protein (albumin) level must meet a minimum requirement
• You have at least one area of cancer that can safely be biopsied
• You agree to have tumor biopsies taken before your first dose and on a specific day during treatment
• Your cancer can be measured using standard imaging criteria

Who may not be able to join:

• You have a serious medical condition, significant abnormal lab result, or mental health condition that would make it unsafe or unsuitable for you to participate
• You have any condition that puts you at too high a risk if you join the study
• You have any condition that would make it hard to understand or interpret your results in the study
• You have cancer that has spread to the brain and is currently causing symptoms — however, previously treated and stable brain metastases for at least 6 weeks may be allowed (confirm with trial site)
• You have been diagnosed with acute or long-term inflammation of the pancreas (pancreatitis)
• You have moderate or severe nerve damage causing symptoms such as numbness, tingling, or pain (confirm with trial site)
• You have ongoing diarrhea or problems absorbing food that is moderate or worse and has not been controlled with treatment
• You have difficulty swallowing pills or oral medication
• You have unstable chest pain, a significant heart rhythm problem, or moderate to severe heart failure
• You have recently received cancer treatment or an experimental therapy (within a certain timeframe before starting the study) or have not yet recovered from its side effects — hair loss is an exception (confirm timing with trial site)
• You had major surgery within 2 weeks before starting the study, or you have not yet recovered from surgery
• You are pregnant or currently breastfeeding
• You have a known HIV infection
• You have a known chronic hepatitis B or C infection — unless hepatitis C is a pre-existing condition alongside your cancer (confirm with trial site)
• Your cancer has spread to the liver and your blood protein (albumin) level is too low
• You have had another cancer in the past 5 years — exceptions may include certain treated skin cancers or cervical pre-cancers (confirm with trial site)