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A Phase 1 Study of Sl-901 in Patients with Advanced Solid Tumours

  • Research type

    Research Study

  • Full title

    A Phase I, open label, dose-escalation study of the PI3K inhibitor SL-901 in patients with advanced solid tumors.

  • IRAS ID

    289189

  • Contact name

    Deborah Norby

  • Contact email

    DNorby@stemline.com

  • Sponsor organisation

    Stemline Therapeutics, Inc

  • Eudract number

    2019-004135-22

  • Clinicaltrials.gov Identifier

    NA, NA

  • Duration of Study in the UK

    2 years, 6 months, 0 days

  • Research summary

    This study will enrol adult patients with advanced solid tumours for whom no effective standard therapy options are available.
    This study will include approximately 108 patients in 3 centres in the UK.
    The main purpose of the escalation part of the study is to find the highest dose of the investigational drug SL-901 that can be given to patients without causing severe side effects and evaluate if once daily or twice daily dosing is best. Each treatment cycle is 28 days long. The study will then be expanded and the chosen dose and schedule will be tested in groups of patients with specific genetic alterations that are more likely to derive benefit from treatment with the drug.

    Other objectives of the study are to understand how the body handles SL-901, called pharmacokinetics (PK), what SL-901 does to the body, called pharmacodynamics (PD) and to find out what effect SL-901 may have on cancer growth
    The results of this part of the study will be used to determine the best dose for future patients.
    Patients could be on this study as long as they are benefiting from the treatment. Overall study duration (including enrolling, treatment and evaluation) This will range from approximately 2 months to a maximum of about 2 years.

  • REC name

    London - Surrey Borders Research Ethics Committee

  • REC reference

    20/LO/1235

  • Date of REC Opinion

    7 Jan 2021

  • REC opinion

    Further Information Favourable Opinion

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