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, Open-Label Study of the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Activity of Tolinapant in Combination with Oral Decitabine/Cedazuridine and Oral Decitabine/Cedazuridine Alone in Subjects with Relapsed/Refractory Peripheral T-cell Lymphoma

    Cancer Categories
    • Hematologic (Blood Cancers)
    Karmanos Trial ID
    • 2022-093
    NCT ID
    • NCT05403450
    Age Group
    • Adult
    • 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
    • Dipenkumar
      Modi, M.D.

      Oncology - Hematology, Oncology - Medical View Profile


    Primary Objectives:

    • Phase 1: To assess safety, and to identify the recommended phase 2 dose (RP2D) of tolinapant in combination with oral decitabine/cedazuridine.
    • Phase 2: To assess preliminary efficacy as determined by overall response rate (ORR).

    Secondary Objectives:

    Phase 1:

    • To assess safety and to identify the tolerated dosing of oral decitabine/cedazuridine alone in this population.
    • To determine the pharmacokinetic (PK) parameters of both tolinapant and oral decitabine/cedazuridine.

    Phase 2:

    • To evaluate other efficacy parameters, based on CT imaging.
    • To evaluate other efficacy parameters, based on CT combined with positron emission tomography (PET) imaging assessments.
    • To assess preliminary efficacy by ORR with the assessment for pseudo progression.
    • To evaluate anti-tumor responses based on PTCL subtypes.
  • Locations


    Karmanos Cancer Institute - Detroit Headquarters

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

    Karmanos Cancer Institute at Weisberg Cancer Center - Farmington Hills

    31995 Northwestern Hwy
    Farmington Hills, MI 48334
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    Phone: 800-527-6266