tesetaxel (DJ 927)

P2, N=294, Terminated, Odonate Therapeutics, Inc. | Trial completion date: Aug 2023 --> Jun 2021 | Recruiting --> Terminated | Trial primary completion date: Aug 2022 --> Jun 2021; The Sponsor has discontinued the development of tesetaxel

P2, N=152, Terminated, Odonate Therapeutics, Inc. | Trial completion date: Mar 2022 --> Jun 2021 | Active, not recruiting --> Terminated | Trial primary completion date: Mar 2021 --> Jun 2021; The Sponsor has discontinued the development of tesetaxel

P3, N=685, Terminated, Odonate Therapeutics, Inc. | Trial completion date: Mar 2023 --> Jun 2021 | Active, not recruiting --> Terminated; The Sponsor has discontinued the development of tesetaxel

An all-oral regimen of T plus a reduced dose of C demonstrated a high level of antitumor activity in pts with HR+, HER2- MBC not previously treated with a taxane . The confirmed ORR was 51%, median DoR was 9.5 mo and median PFS was 12.9 mo . Neutropenia was the most frequent Gr ≥3 TEAE; the rate of febrile neutropenia was 4.7% .

No abstract available

No abstract available

P2, N=320, Recruiting, Odonate Therapeutics, Inc. | N=130 --> 320 | Trial primary completion date: Sep 2021 --> Aug 2022

P2, N=125, Active, not recruiting, Odonate Therapeutics, Inc. | Recruiting --> Active, not recruiting

An all-oral regimen of tesetaxel plus a reduced dose of capecitabine significantly improved PFS versus capecitabine alone. Neutropenia was the most frequent Grade ≥3 TEAE. Rates of clinically significant alopecia and neuropathy were low.

Nivolumab and pembrolizumab (PD-1 inhibitors) and atezolizumab (a PD-L1 inhibitor) are approved for the treatment of multiple types of cancer; atezolizumab, in combination with nab-paclitaxel, was recently approved in the US for the treatment of metastatic TNBC. The study was initiated in March 2019. Research Funding: Odonate Therapeutics, Inc

Nivolumab and pembrolizumab (PD-1 inhibitors) and atezolizumab (a PD-L1 inhibitor) are approved for the treatment of multiple types of cancer; atezolizumab, in combination with nab-paclitaxel, was recently approved in the U.S. for the treatment of metastatic TNBC. The Study was initiated in March 2019. For further information on this trial, email joconnell@odonate.com or visit clinicaltrials.gov (NCT03952325).

Tesetaxel is a novel, oral taxane that has potential advantages over currently available taxanes, including: oral administration with a low pill burden and once every 3 week (Q3W) dosing; no observed hypersensitivity reactions; preclinical evidence of central nervous system (CNS) penetration; and improved activity against chemotherapy-resistant tumors. The interim efficacy futility analysis was based on a pre-specified analysis of the first approximate 100 PFS events that occurred in the study. For further information on this trial, email joconnell@odonate.com or visit clinicaltrials.gov (NCT03326674).

Enrollment was initiated in January 2019. For further information on this trial, email joconnell@odonate.com or visit clinicaltrials.gov (NCT03858972).