A Study to Assess the Safety, Tolerability, and Effectiveness of KPT-9274 to Treat Patients who have Advanced Solid Malignancies or Non-Hodgkin's Lymphoma

Overview

About this study

The purpose of this study is to evaluate the safety, tolerability, and effectiveness of oral KPT-9274 for the treatment of patients who have advanced solid malignancies or non-Hodgkin's lymphoma.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

  • Advanced solid malignancies or Non-Hodgkins lymphoma for which all standard therapeutic options considered useful have been exhausted
  • Must have objective evidence of progressive disease on study entry
  • Measureable Advanced solid malignancy disease as defined by RECIST 1.1
  • Measureable non-Hodgkins lymphoma disease including target lesion(s) as defined by the Lugano Classification for initial evaluation and staging
  • Must have a site of disease amenable to biopsy and be a candidate for biopsy
  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤1
  • For dose expansion phase of KPT-9274 + niacin ER cohort only, NAPRT1 and IDH1 tumor status must be determined at the central laboratory prior to enrollment
  • Life expectancy of ≥3 months

Exclusion Criteria

  • Known central nervous system (CNS) disease or leptomeningeal involvement, regardless of response to prior therapy
  • Major surgery within 4 weeks before C1D1
  • Active infection with completion of therapeutic antibiotics, antivirals, or antifungals within one week prior to C1D1
    • Prophylactic antibiotics, antivirals or antifungals are permitted
  • Known history of Human Immunodeficiency Virus (HIV)
    • HIV testing is not required as part of this study
  • Known, active hepatitis A, B, or C infection or known to be positive for HCV RNA or HBsAg (HBV surface antigen)
  • Significant diseased or obstructed gastrointestinal tract or uncontrolled vomiting or diarrhea that could interfere with the absorption of KPT-9274
  • Active peptic ulcer disease or other active gastrointestinal bleeds

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Amit Mahipal, M.B.B.S.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available
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CLS-20260196

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