CDK4/6 Tumor, Abemaciclib, Paclitaxel

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

February 25, 2021

Primary Completion Date

July 16, 2024

Study Completion Date

August 10, 2024

Conditions
Tumors
Interventions
DRUG

abemaciclib+paclitaxel

"Phase 1b: About 3-6 patients enrollment is expected at dose level 1, -1 and -2. Dose reduction will be preceded with 3 patients/cohort until the first DLT with 4 weeks' observation. The recommend phase 2 dose (RP2D) will be defined.~level1: abemaciclib 100mg bid, D1-28 / paclitaxel 80mg/m2, IV. D1, 8, 15 Q 4 weeks level-1: abemaciclib 100mg bid, D1-28 / paclitaxel 70mg/m2, IV. D1, 8, 15 Q 4 weeks level-2: abemaciclib 50mg bid, D1-28 / paclitaxel 70mg/m2, IV. D1, 8, 15 Q 4 weeks~Phase2: At the RP2D dose level in phase I part, we will expand phase 2 study."

Trial Locations (1)

03722

Severance Hospital, Seoul

All Listed Sponsors
lead

Yonsei University

OTHER

NCT04594005 - CDK4/6 Tumor, Abemaciclib, Paclitaxel | Biotech Hunter | Biotech Hunter