Using Tumor Models to Determine Treatments

Exclusion Criteria

• •1. Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen.
• •2. Patient received last dose of chemotherapy within 21 days prior to Cycle 1 Day 1.
• •3. Patients with ongoing toxicity ≥ Common Terminology Criteria for Adverse Events (CTCAE) grade 2, other than peripheral neuropathy, related to prior anti-tumour treatment.
• •4. Patients with ongoing peripheral neuropathy of ≥ CTCAE grade 3 will be excluded.
• •5. Patients concurrently receiving any other anti-cancer therapy (cytotoxic, biologic, radiation, or hormonal other than for replacement) except for medications that are prescribed for supportive care but may potentially have an anti-cancer effect (e.g. megestrol acetate, bisphosphonates). These medications must have been started ≥ one month prior to enrolment in this study.
• •6. Patients with a history of a severe allergic reaction attributed to compounds of similar or biologic composition to the PDO matched drug may be excluded if assessed by the investigator and determined to be unsafe to proceed.
• •7. Patients may be on warfarin, low molecular weight heparin or direct factor Xa inhibitors, unless such therapies are prohibited by drug-specific ineligibility criteria.
• •8. Patients with known active progressive brain metastases. Patients with previously treated brain metastases are eligible, provided that the patient has not experienced a seizure or had a clinically significant change in neurological status within one month prior to screening. All patients with previously treated brain metastases must be stable (clinically and radiologically) for at least one month after completion of treatment and either off steroid treatment or only taking physiological doses of steroids prior to the screening step.
• •9. Patients with clinically significant pre-existing cardiac conditions, including uncontrolled or symptomatic angina, uncontrolled atrial or ventricular arrhythmias, or symptomatic congestive heart failure.
• •10. Patients with known left ventricular ejection fraction (LVEF) \< 40 % as determined by a multigated acquisition (MUGA) scan or echocardiogram.
• •11. Patients with stroke (including TIA) or acute myocardial infarction within three months prior to the screening step.
• •12. Patients with acute gastrointestinal bleeding within one month prior to the screening step.
• •13. Patients with any other clinically significant medical condition which, in the opinion of the treating physician, makes it undesirable for the patient to participate in the study or which could jeopardize compliance with study requirements including, but not limited to ongoing or active infection, significant uncontrolled hypertension, or severe psychiatric illness/social situations.
• •14. Lactating and nursing women.
• •15. Patients who do not meet drug-specific eligibility requirements for the drug selected by the treating physician.