A Phase 1 and Pharmacokinetic Single Agent Study of in Patients Study Agent with Advanced Malignancies and Varying Degrees of Liver Dysfunction Physician of record: Site Co-Investigator: NCI Investigator Number: NCI Investigator Number: Institution Name: Participating Site (Institution): NCI Site Code: NCI Site Code: Address: Address: Phone: ( ) Phone: ( ) Fax: ( ) Fax: ( ) E-mail: E-mail: Initials (First, ……Patient Middle, Last) Date of …….Patient Birth (mm/dd/yyyy) PATIENT DISEASE Primary Disease Site Stage of Disease Disease Grade Histology ELIGIBILITY CHECKLIST □ □ No 1. Patient has a histologically or cytologically confirmed solid or hematologic malignancy that is Yes metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective. □ □ No 2. Patient is > 18 years of age. Yes □ □ No 3. Life expectancy is greater than 3 months. Yes □ □ No 4. performance status (ECOG scale) is < 2 (Karnofsky > 60%) Yes Patient’s □ □ No 5. Patient has acceptable marrow and renal function as defined below: Yes - ANC > 1.5 x 109/L platelet count > 100 x 109/L creatinine level within normal institutional limits OR creatinine clearance >60 mL/min/1.73 m2 if creatinine level is above patient’s institutional normal □ □ No 6. Patient is free of unstable or untreated (non-irradiated) brain metastases. Yes □ □ Yes 7. Does patient have a history of allergic reactions to compounds of similar chemical or biologic No composition to Study Agent.?_ □ □ Yes 8. Does patient have any intercurrent illness including (but not limited to) the following: No ongoing or active infection symptomatic congestive heart failure unstable angina pectoris cardiac arrhythmia psychiatric illness/social situations that would limit compliance with study requirements? □ □ Yes 9. Is patient pregnant? No
A Phase 1 and Pharmacokinetic Single Agent Study of Study Agent in Patients with Advanced Malignancies and Varying Degrees of Liver Dysfunction Physician of record: Site Co-Investigator: NCI Investigator Number: NCI Investigator Number: Institution Name: Participating Site (Institution): NCI Site Code: NCI Site Code: Address: Address: Phone: ( ) Phone: ( ) Fax: ( ) Fax: ( ) E-mail: E-mail: ……Patient Initials (First, Middle, Last) …….Patient Date of Birth (mm/dd/yyyy) PATIENT DISEASE Primary Disease Site Stage of Disease Disease Grade Histology ELIGIBILITY CHECKLIST □ No □ Yes 1. Patient has a histologically or cytologically confirmed solid or hematologic malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective. □ No □ Yes 2. Patient is > 18 years of age. □ No □ Yes 3. Life expectancy is greater than 3 months. □ No □ Yes 4. Patient’s performance status (ECOG scale) is < 2 (Karnofsky > 60%) □ No □ Yes 5. Patient has acceptable marrow and renal function as defined below: - ANC > 1.5 x 109/L platelet count > 100 x 109/L creatinine level within normal institutional limits OR creatinine clearance >60 mL/min/1.73 m2 if patient’s creatinine level is above institutional normal □ No □ Yes 6. Patient is free of unstable or untreated (non-irradiated) brain metastases. □ No □ Yes 7. Does patient have a history of allergic reactions to compounds of similar chemical or biologic composition to Study Agent.?_ □ No □ Yes 8. Does patient have any intercurrent illness including (but not limited to) the following: ongoing or active infection symptomatic congestive heart failure unstable angina pectoris cardiac arrhythmia psychiatric illness/social situations that would limit compliance with study requirements? □ No □ Yes 9. Is patient pregnant?
Hepatic_Dysfunction_Template_v4.docx