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Table 1 Items and timing of observation, tests and research

From: Safety and efficacy of MIKE-1 in patients with advanced pancreatic cancer: a study protocol for an open-label phase I/II investigator-initiated clinical trial based on a drug repositioning approach that reprograms the tumour stroma

  1. Essential
  2. Only in the phase I study
  3. 1) During the investigational treatment period, the test will be performed before the investigational dosing.
  4. 2) Administration of the study drug will be started within 8 days defining the date of enrollment as Day 1.
  5. 3) If the timing of testing for discontinuation overlaps with that of the test scheduled 30 days after the final dosing, for example, when the investigational drug was skipped repeatedly and then discontinued, the test for discontinuation will be performed and the results will also be used as the test 30 days after the final dosing.
  6. 4) The acceptable range of the test dates will be determined in reference to the dosing date. For example, if a dose is administered on Day 7, the acceptable range of the test will be Day 6 to Day 7. Tests scheduled on the dosing date will be performed before dosing.
  7. 5) Until the post observation period is completed in all cases.
  8. 6) Dosing on Day 1 of Course 1 will basically be performed in a hospital setting. Thereafter, dosing will be administered regardless of whether in a hospital setting or outpatient setting considering the subject’s condition.
  9. 7) In the phase II study, biopsy from liver metastasis foci will be performed in subjects from whom additional consent has been obtained.
  10. 8) Body height will also be measured on Day 7.
  11. 9) Results obtained within 10 days can be used if available.
  12. 10) Results obtained within 4 weeks can be used if available.