Drug Information
Drug 1
Generic/working name	AZD8186
Company name	AstraZeneca (Cambridge, UK)
Drug type	Small molecule
Drug class	Selective PI3Kβ/δ inhibitor
Dose	120 mg BID [5 days on, 2 days off; every week (phase II part)]
Unit	mg
Route	Oral (po)
Schedule of administration	In the dose-escalation phase Ib part, 3+3 design was applied with 4-dose level evaluation planned (Table 2). The starting dose of AZD8186 was 60 mg PO twice-daily (BID; 5 days on/2 days off), with planned escalation to 120 mg PO BID. AZD8186 was taken orally twice daily at approximately the same time (12 ± 1 h) each day on an empty stomach (water only for at least 2 h prior and 1 h after each dose) for 5 days on, 2 days off every week (days 1-5, 8-12, 15-19, and 22-26). In this dose-escalation part, both MTD and RP2D were determined at AZD8186 120 mg BID and paclitaxel 80 mg/m2. In the phase II part, AZD8186 (120 mg) was taken orally BID each day for 5 days on, 2 days off every week. One cycle of AZD8186 and paclitaxel combination therapy was 28 days, and AZD8186 was administered alone in the 4th week without paclitaxel administration. AZD8186 was provided by AstraZeneca.
Drug 2
Generic/working name	Paclitaxel
Company name	(1) Phase Ib part; Paxel (Hanmi Pharmaceutical, Seoul, Korea) (2) Phase II part; Whether it was an original drug or a generic drug, it was used according to the circumstances of each institution.
Drug type	Small molecule
Drug class	Mitotic—kinetic spindle protein
Dose	80 mg/m2 [On day 1, 8, 15 every 4 weeks (phase II part)]
Unit	mg
Route	IV
Schedule of administration	In the dose-escalation phase Ib part, subjects were planned to receive oral AZD8186 (60 mg or 120 mg; twice-daily; 5 days on/2 days off) plus intravenous paclitaxel (70 mg/m2 or 80 mg/m2; days 1, 8, and 15) every 4 weeks (Table 2). Paclitaxel (Paxel) was provided by Hanmi Pharmaceutical. In the phase Ib part, both MTD and RP2D were determined at AZD8186 120 mg BID and paclitaxel 80 mg/m2. In the phase II part, intravenous paclitaxel (80 mg/m2) was administered on days 1, 8, and 15 every 4 weeks.