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    DRUG:

    Liporaxel (paclitaxel oral)

    i
    Other names: DHP107, DHP-107, RMX-3001
    Company:
    Dae Hwa, HaiHe Biopharma
    Drug class:
    Bcl2 inhibitor, Tubulin inhibitor
    Related drugs:
    4ms
    Food Effect on Pharmacokinetics and Safety of DHP107 (Liporaxel®) FEEL Study (clinicaltrials.gov)
    P1, N=25, Completed, Daehwa Pharmaceutical Co., Ltd. | Not yet recruiting --> Completed
    Trial completion • Metastases
    |
    Liporaxel (paclitaxel oral)
    4ms
    OPTIMAL: Oral Paclitaxel Trial In Recurrent and Metastatic Breast Cancer As 1st Line Therapy (clinicaltrials.gov)
    P2/3, N=549, Active, not recruiting, Daehwa Pharmaceutical Co., Ltd. | Trial completion date: Mar 2024 --> Dec 2025
    Trial completion date • Metastases
    |
    paclitaxel • Liporaxel (paclitaxel oral)
    8ms
    GIST Oral Paclitaxel(Liporaxel) (clinicaltrials.gov)
    P2, N=28, Not yet recruiting, Asan Medical Center
    New P2 trial
    |
    paclitaxel • imatinib • sunitinib • Stivarga (regorafenib) • Liporaxel (paclitaxel oral)
    9ms
    OPERA: Oral Paclitaxel Efficacy Safety and PK in Recurrent and Metastatic Breast Cancer (clinicaltrials.gov)
    P2, N=72, Completed, Daehwa Pharmaceutical Co., Ltd. | Unknown status --> Completed
    Trial completion • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    Liporaxel (paclitaxel oral)
    10ms
    Anti-cancer effects of DHP107 on canine mammary gland cancer examined through in-vitro and in-vivo mouse xenograft models. (PubMed, BMC Vet Res)
    Our results suggest that paclitaxel may have anti-cancer effects on CMGC through cell cycle arrest, induction of apoptosis, and anti-angiogenesis. This study could provide a novel approach to treat CMGC.
    Preclinical • Journal
    |
    CCND1 (Cyclin D1) • PECAM1 (Platelet And Endothelial Cell Adhesion Molecule 1)
    |
    Liporaxel (paclitaxel oral)
    11ms
    OPTIMAL: Oral Paclitaxel Trial In Recurrent and Metastatic Breast Cancer As 1st Line Therapy (clinicaltrials.gov)
    P2/3, N=549, Active, not recruiting, Daehwa Pharmaceutical Co., Ltd. | Unknown status --> Active, not recruiting | Trial completion date: Mar 2022 --> Mar 2024 | Trial primary completion date: Dec 2020 --> Jan 2024
    Enrollment closed • Trial completion date • Trial primary completion date • Metastases
    |
    paclitaxel • Liporaxel (paclitaxel oral)
    over2years
    Phase II study of DHP107 oral paclitaxel compared to IV paclitaxel in patients with HER2-negative recurrent or metastatic breast cancer (MBC): Opera (NCT03326102) (ESMO 2022)
    Conclusions The oral paclitaxel, DHP107 showed comparable efficacy and a differential safety including less neuropathy compared to IV ptx in pts with MBC. The ongoing OPTIMAL Phase III will enroll 556 subjects with MBC in Korea, China and Europe to test non-inferiority of DHP107 to IV ptx (NCT03315364).
    Clinical • P2 data
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    Liporaxel (paclitaxel oral)
    almost3years
    Phase II study of DHP107 (oral paclitaxel) in the first-line treatment of HER2-negative recurrent or metastatic breast cancer (OPTIMAL study). (PubMed, Ther Adv Med Oncol)
    DHP107 showed promising efficacy and acceptable tolerability in this phase II study and is currently being investigated in the OPTIMAL phase III study (NCT03315364). This trial was registered with ClinicalTrials.gov identifier: NCT03315364.
    Clinical • P2 data • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    Liporaxel (paclitaxel oral)
    over4years
    [VIRTUAL] [OPTIMAL 3] A phase III trial to evaluate the efficacy and safety of DHP107 (Liporaxel, oral paclitaxel) compared to Taxol (IV paclitaxel) as first line therapy in patients with recurrent or metastatic HER2 negative breast cancer (BC) (NCT03315364). (ASCO 2020)
    Final results of this study will be announced by the end of 2022. Research Funding: DAEHWA Pharmaceutical Co,.Ltd.
    Clinical • P3 data
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    Liporaxel (paclitaxel oral)
    over4years
    OPERA: Oral Paclitaxel Efficacy Safety and PK in Recurrent and Metastatic Breast Cancer (clinicaltrials.gov)
    P2, N=72, Recruiting, Daehwa Pharmaceutical Co., Ltd. | Trial completion date: Dec 2021 --> Apr 2022 | Trial primary completion date: Dec 2019 --> Sep 2020
    Clinical • Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    Liporaxel (paclitaxel oral)
    5years
    A phase II study to evaluate the efficacy, safety and pharmacokinetics of DHP107 (Liporaxel®, oral paclitaxel) compared to IV paclitaxel in patients with recurrent or metastatic breast cancer: OPERA (NCT03326102) (SABCS 2019)
    Target Accrual: The first subject was enrolled in July 2018 and recruitment is ongoing. Enrollment of 72 evaluable subjects is expected to complete in Q2 2020.
    Clinical • P2 data • PK/PD data
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    Liporaxel (paclitaxel oral)