Study of CP-383 in Patients With Advanced or Metastatic Solid Tumors

Other illness

• Known history of HIV, HCV, HBV unless cured, controlled with undetectable viral load
• Clinically significant liver disease
• Significant gastrointestinal diseases
• History of other cancer within past 5 years with certain exceptions for cancers that are likely cured
• Significant cardiac disease
• Other diseases that are not well controlled that could make taking the drug unsafe
• Exposure to certain anti-cancer or other drugs within a certain period before the start of study drug

Other

• Inability to swallow pills
• Active tumor in the brain
• pregnant or lactating females

• Measurable or non measurable cancer that the research can assess for changes
• Not eligible or able to take existing standard therapies for cancer
• Availability of a part of a tumor for laboratory testing or willing to have a safe biopsy taken from a tumor
• Diagnosed with locally advanced, recurrent or metastatic incurable disease
• Part 1: any solid tumor (with the exception of brain cancer) that has progressed, standard therapy is no longer or has not helped the cancer, or is too toxic and for whom a clinical trial is an option for continued treatment
• Part 1: specific advanced, metastatic tumor types will also be enrolled: colorectal cancer, small cell lung cancer, head and neck cancer, non-small cell lung cancer, pancreatic cancer, bladder cancer - some of these will have a specific gene mutation in the cancer
• Part 1: selected solid tumor cancer types (with the exception of brain cancers) that have a specific gene mutation in the cancer
• Part 2: specific advanced, metastatic tumor types will also be enrolled: colorectal cancer, small cell lung cancer, head and neck cancer - some of these will have a specific gene mutation in the cancer
  • \_ Part 2: selected solid tumor cancer types (with the exception of brain cancers) that have a specific gene mutation in the cancer
• Adequate blood and urine lab tests
• Women and men of childbearing potential with adequate contraception
• Provides written informed consent
• Willing to comply with the requirements of the protocol