Safety of the Combination of SH003 and Docetaxel in Patients With Solid Cancer
Status:
Not yet recruiting
Trial end date:
2021-08-01
Target enrollment:
Participant gender:
Summary
The study is designed as a single Group, Dose Elevating trial which evaluates safety to
confirm the final maximum tolerated dose by the combination of oral administration of SH003
to docetaxel administered patients.
Firstly, 3 subjects is recruited and administered for 21 days for the starting dose of 2,400
mg / day. If no DLT occurs, raise the dose to a secondary dose of 3,600 mg / day. If DLT
occurs, additional 3 subjects are recruited and administered for 2,400mg / day. After, If two
or more of the six subjects shows DLT, stop the capacity increase, whereas if DLT occurs in
less than 1 person, increase the dose to 3,600 mg / day. Next, 3 subjects is recruited and
administered for 21 days for a dose of 3,600 mg / day. If no DLT occurs, raise the dose to
4,800 mg / day. If DLT occurs, 3 subjects are additionally recruited and administered for
3,600 mg / day. After, If two or more of the six subjects shows DLT, stop the capacity
increase, whereas if DLT occurs in less than 1 person, increase the dose to 4,800 mg / day.
Finally, 3 subjects is recruited and administered for a dose of 4,800 mg / day. If no DLT
occurs, complete the study. If DLT occurs, additional 3 subjects are recruited and
administered for 4,800mg / day and complete the study after observation.