9.1 23BOverall Study Design and Plan This was an open-label, multicenter, dose-escalation and pharmacokinetic Phase I study of CBP501 and cisplatin administered as consecutive IV infusions according to a once-every-3-weeks schedule in patients with advanced solid tumors refractory to standard therapy. The study was conducted in three US centers. During the course of the study, an amendment was introduced (#3, October 17th, 2007; see section X9.8X) to allow administration of a unique dosing of single agent CBP501 prior to the initiation of combination therapy to enable completion of the pharmacokinetic (PK) characterization of single agent CBP501. Pharmacodynamic analysis involving phosphoserine 216 evaluations was also removed. See section X16.1.1X for copies of the protocol and all protocol amendments. With 8 additional patients included at the recommended dose (at DL6), it was decided to stop all PK and CTC sampling (and therefore the day-7 CBP501 alone infusion), as sufficient information had been retrieved. In addition, based on evidence of efficacy observed in ovarian cancer patients, a further 10 ovarian and 4 endometrial cancer patients were to be included at the recommended dose; these patients were to be assessed for DLT to confirm the identification of the MTD.