 Statistical Methods: Response rate with 95 CI and median time to progression of disease will be calculated. Success will be declared if the lower limit of the 95 CI of the response rate is greater than 10. The 95 CI of the response rate will be calculated using exact methods. Survival curve will be estimated using Kaplan-Meier Method. Descriptive statistics will be used to describe patient demographics, adverse events, serious adverse events and reasons for termination. Two approaches to the efficacy and safety analyses will be done; the ITT intent-to-treat for the efficacy analysis and safety. The ITT analysis consists of patients who received at least one dose of the study drug and at least one on-treatment measurement of the primary efficacy endpoint overall response. The safety analysis consists of patients who received at least one dose of the study drug and at least one safety measurement done. A detailed description of the statistical methods, table and listing shells will be provided in the statistical analysis SAP before database lock or data transfer to the study biostatistician. 