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    DRUG:

    docetaxel oral/ritonavir (ModraDoc006/r)

    i
    Other names: ModraDoc006/r, ModraDoc 006/r, ModraDoc 006
    Associations

    News

    Trials
    Company:
    Modra Pharma
    Drug class:
    Tubulin polymerization promoter, Microtubule stabilizer, Protease inhibitor
    Related drugs:
    Associations

    News

    Trials
    7ms
    Oral Docetaxel (ModraDoc/r) in Combination With Hormonal Treatment and Radiation Therapy in High-risk Prostate Cancer (clinicaltrials.gov)
    P1, N=24, Terminated, The Netherlands Cancer Institute | Unknown status --> Terminated; low inclusion of patients and availability of the IP
    Trial termination • Combination therapy
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    docetaxel oral/ritonavir (ModraDoc006/r) • ritonavir
    8ms
    ModraDoc006/r vs Docetaxel IV in Metastatic Prostate Cancer (clinicaltrials.gov)
    P2, N=135, Completed, Modra Pharmaceuticals | Phase classification: P2b --> P2 | N=102 --> 135
    Phase classification • Enrollment change • Metastases
    |
    docetaxel oral/ritonavir (ModraDoc006/r)
    3years
    ModraDoc006/r in Patients With Breast Cancer (clinicaltrials.gov)
    P2a, N=12, Completed, Modra Pharmaceuticals | Recruiting --> Completed | N=24 --> 12 | Trial completion date: Jan 2020 --> Nov 2020
    Clinical • Trial completion • Enrollment change • Trial completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    docetaxel oral/ritonavir (ModraDoc006/r)
    3years
    Food Effect Study of ModraDoc006 in Combination With Ritonavir (clinicaltrials.gov)
    P1, N=18, Completed, Modra Pharmaceuticals | Active, not recruiting --> Completed
    Trial completion • Combination therapy
    |
    ABCB1 (ATP Binding Cassette Subfamily B Member 1) • ABCC2 (ATP Binding Cassette Subfamily C Member 2)
    |
    docetaxel oral/ritonavir (ModraDoc006/r)
    almost4years
    Investigating the influence of relevant pharmacogenetic variants on the pharmacokinetics and pharmacodynamics of orally administered docetaxel combined with ritonavir. (PubMed, Pharmacogenomics J)
    The anticancer drug docetaxel exhibits large interpatient pharmacokinetic and pharmacodynamic variability. Our post hoc power analysis indicated that our pharmacogenetic-pharmacokinetic analysis was only powered for relatively high effect sizes, which were to be expected given the high interpatient variability. This makes it unlikely that future studies will explain the high observed interpatient variability in oral docetaxel pharmacokinetics as a result of any of these separate polymorphisms and diplotypes.
    PK/PD data • Journal
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    ABCB1 (ATP Binding Cassette Subfamily B Member 1) • SLCO1B3 (Solute carrier organic anion transporter family member 1B3) • ABCC2 (ATP Binding Cassette Subfamily C Member 2)
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    docetaxel • docetaxel oral/ritonavir (ModraDoc006/r) • ritonavir
    5years
    ModraDoc006, an oral docetaxel formulation in combination with ritonavir (ModraDoc006/r), in metastasized castration-resistant prostate cancer (mCRPC): A multicenter phase I study. (ASCO-GU 2020)
    Progressive mCRPC patients, who were treatment naïve or previously treated with either abiraterone or enzalutamide, received a maximum of 30 weekly cycles of ModraDoc006/r in a bi-daily once weekly (BIDW) schedule. The RP2D of BIDW ModraDoc006/r in mCRPC was established as 30-20/200-100 mg. These results are encouraging for further development of ModraDoc006/r as a convenient, safe and effective alternative to IV docetaxel for mCRPC patients. A phase 2b study is currently being conducted.
    Clinical • P1 data • Combination therapy
    |
    KLK3 (Kallikrein-related peptidase 3)
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    docetaxel • Xtandi (enzalutamide) • abiraterone acetate • docetaxel oral/ritonavir (ModraDoc006/r)
    5years
    ModraDoc006, an oral docetaxel formulation in combination with ritonavir (ModraDoc006/r), in metastasized castration-resistant prostate cancer (mCRPC): A multicenter phase I study. (ASCO-GU 2020)
    Progressive mCRPC patients, who were treatment naïve or previously treated with either abiraterone or enzalutamide, received a maximum of 30 weekly cycles of ModraDoc006/r in a bi-daily once weekly (BIDW) schedule. The RP2D of BIDW ModraDoc006/r in mCRPC was established as 30-20/200-100 mg. These results are encouraging for further development of ModraDoc006/r as a convenient, safe and effective alternative to IV docetaxel for mCRPC patients. A phase 2b study is currently being conducted.
    Clinical • P1 data • Combination therapy
    |
    KLK3 (Kallikrein-related peptidase 3)
    |
    docetaxel • Xtandi (enzalutamide) • abiraterone acetate • docetaxel oral/ritonavir (ModraDoc006/r)