Having a large clinical trial portfolio means giving patients treatment options often not available anywhere else, and years before they become the standard of care. To learn more about Karmanos Cancer Institute clinical trials or to see if a trial is right for you, please call 1-800-KARMANOS (1-800-527-6266) or request an appointment below
  • A Phase 1/2 Study of M3814 (Peposertib) in Combination with Hypofractionated Radiotherapy for the Treatment of Locally Advanced Pancreatic Adenocarcinoma

    Cancer Categories
    • Gastrointestinal (GI)
    Karmanos Trial ID
    • 2020-080
    NCT ID
    • NCT04172532
    Age Group
    • Adult
    Scope
    • National
    PhaseClick for Clinical Trial Phase DefinitionPhase I
    Includes initial studies to determine the metabolism and pharmacologic actions of drugs in humans, the side effects associated with increasing doses, and to gain early evidence of effectiveness; may include healthy participants and/or patients.
    • Phase I/II
    Principal Investigator
    • Mohammed Najeeb
      Al Hallak, M.D., MS

      Oncology - Medical View Profile

    Objective:

    Primary Objectives:

    • Phase 1: To evaluate the safety and tolerability of M3814 (peposertib) in combination with hypo-fractionated radiotherapy in patients receiving treatment for locally advanced pancreatic adenocarcinoma (LAPC).
    • Phase 2: To determine the difference in progression free survival (PFS) between patients with LAPC treated with hypo-fractionated radiotherapy in combination with M3814 (peposertib) as compared to patients treated with hypo-fractionated radiotherapy alone.
    Secondary Objectives:

    Phase 1
    • To observe and record anti-tumor activity. Although the clinical benefit of this drug has not yet been established, the intent of offering this treatment is to provide a possible therapeutic benefit, and thus the patient will be monitored for response and survival outcomes in addition to safety and tolerability.
    • To evaluate plasma pharmaco-kinetic (PK) profiles of M3814 (peposertib) in patients receiving hypo-fractionated radiotherapy.
    Phase 2
    • To compare the 2year overall survival (OS) rate of patients treated with hypo-fractionated radiotherapy plus M3814 (peposertib) to that of those treated with hypo-fractionated radiotherapy alone.
    • To compare the objective response rate (ORR) by imaging of patients treated with hypo-fractionated radiotherapy plus M3814 (peposertib) to that of those treated with hypo-fractionated radiotherapy alone.
    • To compare the disease control rate in patients treated with hypo-fractionated radiotherapy plus M3814 (peposertib) as compared to those patients treated with hypo-fractionated radiotherapy alone.
    • To explore gene signature patterns in baseline patient tumor tissues that may suggest response to the combination of M3814
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    Locations

    Karmanos Cancer Institute - Detroit Headquarters

    4100 John R
    Detroit, MI 48201
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    Phone: 800-527-6266

    Karmanos Cancer Institute at Lawrence and Idell Weisberg Cancer Treatment Center - Farmington Hills

    31995 Northwestern Hwy
    Farmington Hills, MI 48334
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