Clinical trial example 2

Clinical trial example 2

1. Estimated enrolment - 43 females

2. 18 years +

3. Ongoing study

4. Primary outcome measures; 'progression free survival for a time period of 6 months and 'objective tumour response derived by RECIST for the time frame of 6 months

5. Secondary outcome measures

   • 'progression free survival
   • Frequency of ADE defined as any unfavourable and unintended sign, a symptom or disease in a patient adminstered a medical treatment
     • Event may be related or unrelated to medical treatment time frame of 5 years and severity assessed by CTCAEv3.0 criteria for 5 years

6. Inclusion criteria

   • Confirmed endometrial carcinoma
   • Measurable disease
   • Recieved one more CT agent prior to study
   • Specific test results e.g. platelet count, Hb, creatinine levels, bilirubin, AST/ALT, albumin and others should fit range

7. Exclusion criteria

   • No hyponatremia
   • Not pregnant
   • No poor wound healing
   • No active or no HIV
   • No active or known Hepatitis B or Hepatitis C