1 months as compared to 3. 5 months on the PLD arm. Median survival in the subgroup was 23. 4 months on the canfosfamide plus carboplatin arm as compared to 12. 9 months on the PLD arm. Studies are ongoing currently in platinum resistant human ovarian cancer cells to analyze changing patterns of genetic expression following exposure to platinum and to understand the Inhibitors,Modulators,Libraries optimal DFP following platinum exposure and its relationship to best synergistic response following canfosfamide and carboplatin. Results of a randomized phase 3 study of canfosfamide in combination with PLD versus PLD as second line therapy in platinum resistant OC patients was reported. This multinational study had rando mized 125 patients when the Inhibitors,Modulators,Libraries study was temporarily placed on clinical hold to review the results of the above aforementioned trial single agent canfosfamide trial.
The study was allowed to resume enrollment, however, the sponsor decided not to enroll additional patients. The original study was planned Inhibitors,Modulators,Libraries for 244 patients. The interim analysis became the final analysis. The median PFS was 5. 6 months for canfosfamide plus PLD versus 3. 7 months for PLD. A pre planned subgroup analysis showed that 75 patients with platinum refractory or primary plati num resistant ovarian cancer had a median PFS of 5. 6 months for canfosfamide plus PLD versus 2. 9 months for PLD. Hematologic adverse events were 66% on the canfosfamide plus PLD arm ver sus 44% on the PLD arm, manageable with dose reduc tions. Non hematologic adverse events were similar for both arms. The incidence of PPE and stomatitis was lower on the canfosfamide plus PLD arm versus on the PLD arm.
The overall median PFS showed a positive trend but was not statistically significant. The median PFS in the platinum refractory and primary platinum resistant patients was significantly longer for canfosfamide plus PLD versus PLD. Canfosfamide may ameliorate Inhibitors,Modulators,Libraries the PPE and stomatitis known to be associated with PLD. In summary, the phase 3 results are consistent with the canfosfamide plus PLD regimen phase 2 results pre sented in this paper. Further study is planned with can fosfamide in combination with PLD, an active, well tolerated regimen in patients with platinum refractory and primary platinum resistant ovarian cancer. Non clinical juvenile studies are often used to bridge the knowledge gap between mature and immature sys tems, to detect safety issues early and to predict the dose in children.
A recent survey showed Inhibitors,Modulators,Libraries that in the majority of juvenile toxicity studies, findings were comparable to those selleck chemicals llc for adults, yielding no new information. Fur thermore, novel toxicity was uncommon and could have been predicted from either known pharmacology or from adult data. On the other hand, in a preliminary re view of 5 completed juvenile animal studies required in PIPs, unexpected organ toxicity and increased sensitivity was observed in 3 medicinal products, stressing the im portance of conduction juvenile animal studies.