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  • ||||||||||  Rozlytrek (entrectinib) / Roche, paxalisib (GDC-0084) / Kazia, Verzenio (abemaciclib) / Eli Lilly
    [VIRTUAL] Alliance A071701: Genomically guided treatment trial in brain metastases. (Poster Board 64) -  Feb 27, 2020 - Abstract #ASCO2020ASCO_232;    
    P2
    This study represents a novel individualized therapeutic approach in brain metastases, a disease with a critical need for effective therapy. Research Funding: U.S. National Institutes of Health, Pharmaceutical/Biotech Company, U.S. National Institutes of Health
  • ||||||||||  GDC-0084 / Kazia
    Clinical, Journal:  An LC/ESI-MS/MS method to quantify the PI3K inhibitor GDC-0084 in human plasma and cerebrospinal fluid: validation and clinical application. (Pubmed Central) -  Jan 24, 2020   
    The lower limit of quantitation and limit of detection for GDC-0084 in human plasma were 0.2 ng/mL (signal/noise ≥ 47) and 0.005 ng/mL (signal/noise ≥ 3.5), respectively, and for GDC-0084 in human CSF were 0.2 ng/mL (signal/noise ≥ 19.7) and 0.04 ng/mL (signal/noise ≥ 7.2). This method was successfully applied to analyze serial plasma samples obtained from children with diffuse intrinsic pontine gliomas and other midline gliomas who participated in pharmacokinetic studies as part of a phase I clinical trial of GDC-0084.
  • ||||||||||  GDC-0084 / Kazia
    Multi-parametric MR-PET imaging predicts pharmacokinetics and clinical response to GDC-0084 in human recurrent high-grade glioma (Grand Canyon 8-13) -  Oct 29, 2019 - Abstract #SNO2019SNO_856;    
    P1
    Using this composite multi-parametric MR-PET imaging response biomarker to predict PK, patients with an estimated Cmax >0.1 uM and AUC > 1.25 uM*hr demonstrated significantly longer PFS compared with patients with a lower estimated concentration and exposure (P=0.0039 and P=0.0296, respectively). Results from the current study suggest composite biomarkers created from multi-parametric MR-PET imaging targeting metabolic and/or physiologic processes specific to the drug mechanism of action may be useful for subsequent evaluation of treatment efficacy for larger phase II-III studies.
  • ||||||||||  Cantrixil (TRX-E-002-1) / Kazia
    Biomarker, Preclinical, Journal:  Mechanism of action of the third generation benzopyrans and evaluation of their broad anti-cancer activity in vitro and in vivo. (Pubmed Central) -  Sep 28, 2019   
    In this study, we investigated the mechanism of action of the third-generation benzopyran compounds, TRX-E-002-1 and TRX-E-009-1...This finding along with immunostaining, in vitro polymerization assays, and animal experiments in both athymic and immunocompetent mice, demonstrates that these third-generation benzopyran compounds are potent tubulin polymerization inhibitors in vitro and in vivo, and this is the molecular basis of their anti-cancer activity in melanoma. These findings indicate these BP compounds may offer a novel anti-microtubule strategy for cancer intervention and provides the basis for further investigation into biomarkers of clinical sensitivity.
  • ||||||||||  Enrollment open:  Genetic Testing in Guiding Treatment for Patients With Brain Metastases (clinicaltrials.gov) -  Sep 12, 2019   
    P2,  N=150, Recruiting, 
    Recruiting --> Active, not recruiting | N=60 --> 28 | Trial completion date: Dec 2019 --> Mar 2020 Not yet recruiting --> Recruiting
  • ||||||||||  GDC-0084 / Kazia
    Journal:  GDC-0084 inhibits cutaneous squamous cell carcinoma cell growth. (Pubmed Central) -  Apr 3, 2019   
    In GDC-0084-treated tumor tissues PI3K-Akt-mTOR and DNA-PKcs activation were significantly inhibited. In summary, GDC-0084 inhibits human cSCC cell growth in vitro and in vivo through blocking PI3K-Akt-mTOR and DNA-PKcs signalings.
  • ||||||||||  Herceptin (trastuzumab) / Roche, paxalisib (GDC-0084) / Kazia, SoVarGen, QIMR Berghofer Medical Research Institute
    Enrollment open:  GDC-0084 in Combination with Trastuzumab for Patients with HER2-Positive Breast Cancer Brain Metastases (clinicaltrials.gov) -  Feb 15, 2019   
    P2,  N=47, Recruiting, 
    In summary, GDC-0084 inhibits human cSCC cell growth in vitro and in vivo through blocking PI3K-Akt-mTOR and DNA-PKcs signalings. Not yet recruiting --> Recruiting