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Phase I Study to Evaluate the Maximum Tolerated Dose of the Combination of SH003 and Docetaxel in Patients With Solid Cancer
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.
Details
| Lead sponsor | Kyunghee University Medical Center |
|---|---|
| Phase | Phase 1 |
| Status | UNKNOWN |
| Enrolment | 9 |
| Start date | 2020-06 |
| Completion | 2021-08 |
Conditions
- Solid Tumor
Interventions
- Combination of SH003 and Docetaxel
Primary outcomes
- Dose limiting toxicity — up to 4 weeks
adverse event according to CTCAE