Clinical Trials /

PAK4 and NAMPT in Patients With Solid Malignancies or NHL (PANAMA)

NCT02702492

Description:

This study will evaluate the safety, tolerability, and efficacy of oral KPT-9274 for the treatment of patients with advanced solid malignancies or non-Hodgkin's lymphoma (NHL).

Related Conditions:
  • Malignant Solid Tumor
  • Non-Hodgkin Lymphoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: PAK4 and NAMPT in Patients With Solid Malignancies or NHL (PANAMA)
  • Official Title: A Phase 1 Open-Label Study of the Safety, Tolerability and Efficacy of KPT-9274, a Dual Inhibitor of PAK4 and NAMPT, in Patients With Advanced Solid Malignancies or Non-Hodgkin's Lymphoma

Clinical Trial IDs

  • ORG STUDY ID: KCP-9274-901
  • NCT ID: NCT02702492

Conditions

  • NHL
  • Solid Tumors
  • Sarcoma

Interventions

DrugSynonymsArms
KPT-9274KPT-9274
KPT-9274 & Niacin ERKPT-9274 & Niacin ER

Purpose

This study will evaluate the safety, tolerability, and efficacy of oral KPT-9274 for the treatment of patients with advanced solid malignancies or non-Hodgkin's lymphoma (NHL).

Detailed Description

      This is a first-in-human, multi-center, open-label clinical study with separate Dose
      Escalation and Expansion Phases to assess preliminary safety, tolerability, and efficacy of
      KPT-9274, a dual inhibitor of PAK4 and NAMPT, in patients with advanced solid malignancies
      (including sarcoma, colon, lung, etc.) or NHL for which all standard therapeutic options
      considered useful by the investigator have been exhausted.
    

Trial Arms

NameTypeDescriptionInterventions
KPT-9274Experimentaloral KPT-9274 three times a week every other day (Days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26) during each 28 day cycle.
  • KPT-9274
KPT-9274 & Niacin ERExperimental500 mg niacin ER co-administered with each dose of oral KPT-9274 three times a week every other day (Days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26) during each 28 day cycle.
  • KPT-9274 & Niacin ER

Eligibility Criteria

        Inclusion Criteria:

          -  Advanced solid malignancies or NHL for which all standard therapeutic options
             considered useful have been exhausted.

          -  Must have objective evidence of progressive disease on study entry.

          -  Advanced solid malignancies: Measureable disease as defined by RECIST 1.1.

          -  NHL: Measureable 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.

          -  Dose Expansion Phase (KPT-9274 + niacin ER cohort only): Patient tumors 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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Overall response rate
Time Frame:assessed at 8 weeks
Safety Issue:
Description:Includes complete response and partial response

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Karyopharm Therapeutics Inc

Trial Keywords

  • PAK4
  • KPT-9274
  • Karyopharm
  • NHL
  • solid tumors

Last Updated

May 25, 2017