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

Status: Active

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).

Eligibility Criteria

Inclusion Criteria

  • Inclusion Criteria: Patients must meet all of the following inclusion criteria to be eligible to enroll in this study. 1. Written informed consent obtained prior to any screening procedures and in accordance with federal, local, and institutional guidelines. 2. Age ≥ 18 years. 3. Patients with advanced solid malignancies or NHL. 4. Patients must have a site of disease amenable to biopsy and be a candidate for biopsy according to the treating institution's guidelines. 5. Dose Escalation Phase: Patients will be enrolled according to their NAPRT1 status at a ratio of 2:1 (NAPRT1 negative:NAPRT1 positive). The NAPRT1 status must be determined prior to enrollment based on evaluation of a fresh tumor biopsy or archival tissue prior to screening. 6. Life expectancy of ≥ 3 months. Exclusion Criteria: Patients meeting any of the following exclusion criteria are not eligible to enroll in this study. 1. Time since the last prior therapy for treatment of advanced solid malignancies or NHL**: 1. Radiation, chemotherapy, immunotherapy or any other anticancer therapy, including investigational anti-cancer therapy ≤ 2 weeks prior to C1D1. 2. Palliative steroids for disease related symptoms < 7 days prior to C1D1. **Patients must have recovered or stabilized (Grade 1 or to their baseline for non-hematologic toxicities, ≤ Grade 2 or to their baseline for hematologic toxicities) from toxicities related to their previous treatment except for alopecia. In specific cases, patients with Grade 2 non-hematologic toxicities will be allowed following approval by the Karyopharm medical monitor. 2. Major surgery within four weeks before C1D1. 3. Active infection with completion of therapeutic antibiotics, antivirals, or antifungals within one week prior to C1D1. Prophylactic antibiotics, antivirals or antifungals are permitted. 4. Active peptic ulcer disease or other active gastrointestinal bleeds.

Locations & Contacts

Colorado

Aurora
University of Colorado Hospital
Status: Active
Contact: Tara Ames Wells
Phone: 720-848-0755

District of Columbia

Washington
MedStar Georgetown University Hospital
Status: Active
Name Not Available

Minnesota

Rochester
Mayo Clinic
Status: Active
Contact: Rebecca Thomason
Email: thomason.rebecca@mayo.edu

New York

New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Status: Active
Contact: Karen Martirosyan
Phone: 212-263-4434

Tennessee

Nashville
Vanderbilt University / Ingram Cancer Center
Status: Active
Name Not Available

Texas

Houston
M D Anderson Cancer Center
Status: Active
Contact: Aung Naing
Phone: 713-563-1930
Email: anaing@mdanderson.org

Trial Objectives and Outline

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 Phase & Type

Trial Phase

Phase I

Trial Type

Treatment

Lead Organization

Lead Organization
Karyopharm Therapeutics Inc

Trial IDs

Primary ID KCP-9274-901
Secondary IDs NCI-2016-00611, s16-00464
Clinicaltrials.gov ID NCT02702492