A Broad Multi-histology Phase II Study of the Multi-Kinase Inhibitor R935788 (Fostamatinib Disodium) in Advanced Colorectal, Non-small Cell Lung, Head and Neck Hepatocellular and Renal Cell Carcinomas, and Pheochromocytoma and Thyroid Tumors (Multi-H...

Exclusion Criteria

• •3.2.1 Subjects who have had chemotherapy, biotherapy, or radiotherapy within 4 weeks prior to entering the study, or those who have not recovered from adverse events due to prior therapy.
• •A time period of greater than or equal to 2 weeks must have elapsed since a patient was administered any investigational agent as part of a Phase 0 study (also referred to as an early Phase I study or pre-Phase I study where a sub-therapeutic dose of drug is administered) at the principal investigator's (PI's) discretion, and patients should have recovered from any toxicity from prior therapy to eligibility levels.
• •3.2.2 Patients must not have other current malignancies, other than basal cell skin cancer, squamous cell skin cancer, in situ cervical cancer, ductal or lobular carcinoma in situ of the breast.
• •Patients who have undergone primary therapy for a prior diagnosis of cancer and are disease free for at least 3 years prior to study entry will be included in the trial.
• •3.2.3 Patients may not be receiving any other investigational agents.
• •3.2.4 Subjects with known brain metastases are excluded with the exception of those whose brain metastatic disease status has remained stable for at least 3 months since treatment of the brain metastases without steroids (except for maintenance replacement doses) or antiseizure medications.
• •Patients cannot be taking enzyme-inducing anti-seizure medications (e.g., phenytoin, carbamazepine, phenobarbital, primidone, oxcarbamazepine); other seizure medications that are not considered enzyme-inducing would be permissible.
• •3.2.5 Because there is an unknown but potential risk for adverse events in nursing infants secondary to exposure to this agent, women who are breast feeding are ineligible for this study.
• •3.2.6 Patients receiving medications known to induce/inhibit cytochrome P450 3A4 (CYP3A4) will be excluded from this study.
• •Patients who must initiate treatment with a CYP3A4 inhibitor while receiving R935788 will be carefully monitored.
• •Inhibitors of CYP3A4 include but are not limited to:
• •amiodarone,
• •clarithromycin,
• •erythromycin,
• •imatinib,
• •troleandomycin,
• •ritonavir,
• •indinavir,
• •fluconazole,
• •itraconazole,
• •and ketoconazole.
• •Patients should also avoid grapefruit and grapefruit juice during participation in the study.
• •Patients will also be required to keep a study diary to record any side effects that occur during the study and any other medications taken.
• •3.2.7 Subjects with clinically significant illnesses which would compromise participation in the study, including, but not limited to: unstable or serious medical conditions (ongoing or active infection, symptomatic congestive heart failure \[AHA Class II or worse\], unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements) are excluded due to the possibility that the underlying condition may obscure the attribution of effect and adverse events with respect to the study medication and may limit study compliance.
• •3.2.8 Patients with hepatocellular cancer (HCC) may have underlying chronic infectious hepatitis as long as there is no evidence of hepatic failure and they meet the eligibility criteria.
• •3.2.9 Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with R935788.