KW-2450 / Kyowa Kirin - LARVOL DELTA

Safety Study to Evaluate KW-2450 in Subjects With Advanced Solid Tumor (clinicaltrials.gov) - P1 | N=13 | Completed | Sponsor: Kyowa Kirin Co., Ltd. | N=72 ➔ 13

Enrollment change • Metastases • Monotherapy • Oncology • Solid Tumor

Safety, Tolerability, and Efficacy Study in Subjects With Advanced or Metastatic Breast Cancer (clinicaltrials.gov) - P1 | N=11 | Terminated | Sponsor: Kyowa Kirin Co., Ltd. | Phase classification: P1/2 ➔ P1

Combination therapy • Metastases • Phase classification • Breast Cancer • HER2 Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2

Safety, tolerability, and efficacy study in subjects with advanced or metastatic breast cancer (clinicaltrials.gov) - P2, N=198; Recruiting -> Active, not recruiting

Enrollment closed • Breast Cancer • Oncology

Open-label, sequential, ascending, multi-dose, phase I study of KW-2450 as monotherapy in subjects with previously treated advanced solid tumors (ASCO 2011) - Presentation time: Mon Jun 6, 8:00 AM to 12:00 PM: 2450-US-001, P1, N=13; There were no complete or partial responses; The MTD for KW-2450 was 37.5 mg/day; The AE of note was non-fasting grade 3 hyperglycemia; Rapid oral absorption, peak concentrations in excess of IC50 for IGF1R and IR, and a t1/2 of 10-13 hrs suggest KW-2450 is suitable for once-daily dosing