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    DRUG:

    Liporaxel (paclitaxel oral)

    i
    Other names: DHP107, DHP-107, RMX-3001
    Company:
    Dae Hwa, HaiHe Biopharma
    Drug class:
    Tubulin inhibitor
    Related drugs:
    15d
    GIST Oral Paclitaxel(Liporaxel) (clinicaltrials.gov)
    P2, N=28, Recruiting, Asan Medical Center | Not yet recruiting --> Recruiting
    Enrollment open
    |
    KIT (KIT proto-oncogene, receptor tyrosine kinase) • PDGFRA (Platelet Derived Growth Factor Receptor Alpha) • ANO1 (Anoctamin 1)
    |
    KIT mutation • PDGFRA D842V
    |
    paclitaxel • imatinib • sunitinib • Stivarga (regorafenib) • Liporaxel (paclitaxel oral)
    21d
    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: Dec 2025 --> Nov 2028
    Trial completion date
    |
    paclitaxel • Liporaxel (paclitaxel oral)
    21d
    OPERA: a phase II study of DHP107 (oral paclitaxel) versus intravenous paclitaxel in patients with HER2-negative recurrent or metastatic breast cancer. (PubMed, Breast Cancer Res Treat)
    DHP107 is a tolerable and feasible treatment for patients with recurrent or metastatic HER2-negative breast cancer, with similar efficacy and safety to IV paclitaxel.
    Clinical • P2 data • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    Liporaxel (paclitaxel oral)
    1m
    OPTIMAL: A Multinational Phase III Study of Oral Paclitaxel (DHP107) versus Intravenous Weekly Paclitaxel in HER2-Negative Recurrent or Metastatic Breast Cancer. (PubMed, Ann Oncol)
    DHP107 demonstrated non-inferior efficacy compared to IV paclitaxel, with a manageable safety profile, supporting its use as an effective and convenient alternative in HER2-negative breast cancer.
    P3 data • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    Liporaxel (paclitaxel oral)
    8ms
    OPTIMAL-BC: Neoadjuvant Oral Paclitaxel Plus Subcutaneous Pertuzumab/Trastuzumab in Patients With HER2-positive Breast Cancer (clinicaltrials.gov)
    P=N/A, N=112, Recruiting, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Phesgo (pertuzumab/trastuzumab/hyaluronidase-zzxf) • Liporaxel (paclitaxel oral)
    9ms
    OPTIMAL-BC: Neoadjuvant Oral Paclitaxel Plus Subcutaneous Pertuzumab/Trastuzumab in Patients With HER2-positive Breast Cancer (clinicaltrials.gov)
    P=N/A, N=112, Not yet recruiting, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
    New trial
    |
    Phesgo (pertuzumab/trastuzumab/hyaluronidase-zzxf) • Liporaxel (paclitaxel oral)
    over1year
    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)
    over1year
    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)
    2years
    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)
    2years
    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)
    over2years
    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)
    over2years
    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)