MTD has been exceeded at a Accrual at that dose level or higher is particular dose level terminated for all groups with greater dysfunction. MTD has been established (including Accrual at lower dose levels is results of additional patients up to terminated for all groups with lesser 12) at a particular dose level. dysfunction. MTD has been established (including The MTD is determined to be L-1 in results of additional patients up to both groups, and in both groups, there 12) at a particular dose L while may be additional accrual (up to 12 simultaneously, the MTD has been patients) at dose level L-1, as described exceeded at that dose level in a group in 5.4.4. of lesser dysfunction. 5.5 General Concomitant Medication and Supportive Care Guidelines Please state guidelines for use of concomitant medications or any additional appropriate supportive care medications or treatments. Specifically: Patients should be cautioned about the concomitant use of cimetidine, trimethoprim, or other agents that interfere with creatinine secretion or the creatinine assay. Please indicate any other medications that should be avoided during this evaluation of (Study Agent) in patients with renal dysfunction. For agents known to be metabolized in the liver, please include appropriate information regarding the concurrent use of any medication or therapy with the potential to affect cytochrome P450 isoenzymes. Suggested text is provided below. This text should be deleted for studies of agents with no known hepatic metabolism. Because is a potential for interaction of _Study with concomitantly Agent_ administered drugs through the cytochrome P450 system, the case report form (CRF) must capture the concurrent use of all other drugs, over-the-counter medications, or alternative therapies. The Principal Investigator should be alerted if the patient is taking any agent known to affect or with the potential to affect the P450 isoenzymes. 5.6 Duration of Therapy In the absence of treatment delays due to adverse events, treatment may continue for (# or until one of the following criteria applies: cycles) Disease progression, Intercurrent illness that prevents further administration of treatment, Unacceptable adverse event(s), Patient decides to withdraw from the study, or
MTD has been exceeded at a particular dose level Accrual at that dose level or higher is terminated for all groups with greater dysfunction. MTD has been established (including results of additional patients up to 12) at a particular dose level. Accrual at lower dose levels is terminated for all groups with lesser dysfunction. MTD has been established (including results of additional patients up to 12) at a particular dose L while simultaneously, the MTD has been exceeded at that dose level in a group of lesser dysfunction. The MTD is determined to be L-1 in both groups, and in both groups, there may be additional accrual (up to 12 patients) at dose level L-1, as described in 5.4.4. 5.5 General Concomitant Medication and Supportive Care Guidelines Please state guidelines for use of concomitant medications or any additional appropriate supportive care medications or treatments. Specifically: Patients should be cautioned about the concomitant use of cimetidine, trimethoprim, or other agents that interfere with creatinine secretion or the creatinine assay. Please indicate any other medications that should be avoided during this evaluation of (Study Agent) in patients with renal dysfunction. For agents known to be metabolized in the liver, please include appropriate information regarding the concurrent use of any medication or therapy with the potential to affect cytochrome P450 isoenzymes. Suggested text is provided below. This text should be deleted for studies of agents with no known hepatic metabolism. Because is a potential for interaction of _Study Agent_ with concomitantly administered drugs through the cytochrome P450 system, the case report form (CRF) must capture the concurrent use of all other drugs, over-the-counter medications, or alternative therapies. The Principal Investigator should be alerted if the patient is taking any agent known to affect or with the potential to affect the P450 isoenzymes. 5.6 Duration of Therapy In the absence of treatment delays due to adverse events, treatment may continue for (# cycles) or until one of the following criteria applies: Disease progression, Intercurrent illness that prevents further administration of treatment, Unacceptable adverse event(s), Patient decides to withdraw from the study, or