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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2017 by Karyopharm Therapeutics Inc
Sponsor:
Information provided by (Responsible Party):
Karyopharm Therapeutics Inc
ClinicalTrials.gov Identifier:
NCT02702492
First received: March 3, 2016
Last updated: March 31, 2017
Last verified: March 2017
  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).

Condition Intervention Phase
NHL
Solid Tumors
Sarcoma
Drug: KPT-9274
Drug: KPT-9274 & Niacin ER
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Karyopharm Therapeutics Inc:

Primary Outcome Measures:
  • Overall response rate [ Time Frame: assessed at 8 weeks ]
    Includes complete response and partial response


Estimated Enrollment: 175
Actual Study Start Date: June 2016
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: KPT-9274
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.
Drug: KPT-9274
Experimental: KPT-9274 & Niacin ER
500 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.
Drug: KPT-9274 & Niacin ER

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02702492

Contacts
Contact: Michael Kauffman, MD, PhD mkauffman@karyopharm.com
Contact: Sharon Shacham, PhD sshacham@karyopharm.com

Locations
United States, Colorado
University of Colorado Cancer Center Recruiting
Aurora, Colorado, United States, 80045
Contact: Stephen Leong, MD       Stephen.Leong@ucdenver.edu   
Principal Investigator: Stephen Leong, MD         
United States, District of Columbia
Georgetown University, Lombardi Comprehensive Cancer Center Recruiting
Washington, District of Columbia, United States, 20007
Contact: Michael Pishvaian, MD, PhD       pishvaim@georgetown.edu   
Principal Investigator: Michael Pishvaian, MD, PhD         
United States, Minnesota
Mayo Clinic Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Amit Mahipal, MBBS, MPH    507-293-0462    mahipal.amit@mayo.edu   
Principal Investigator: Amit Mahipal, MBBS, MPH         
United States, New York
NYU-Laura & Isaac Perlmutter Cancer Center Recruiting
New York, New York, United States, 100016
Contact: Daniel Cho    212-731-5871    daniel.cho@nyumc.org   
Principal Investigator: Daniel Cho, MD         
United States, Tennessee
Vanderbilt-Ingram Cancer Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Jordan Berlin, MD         
Contact       Jordan.Berlin@vanderbilt.edu   
Principal Investigator: Jordan Berlin, MD         
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Aung Naing    713-563-0803    anaing@mdanderson.org   
Principal Investigator: Aung Naing, MD         
Canada, Ontario
Princess Margaret Hospital Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Albiruni Razak, MB, BCh    416-586-4800 ext 3883      
Principal Investigator: Albiruni Razak, MB, Bch         
Sponsors and Collaborators
Karyopharm Therapeutics Inc
Investigators
Study Director: Michael Kauffman, MD, Ph.D Karyopharm Therapeutics Inc
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Karyopharm Therapeutics Inc
ClinicalTrials.gov Identifier: NCT02702492     History of Changes
Other Study ID Numbers: KCP-9274-901
Study First Received: March 3, 2016
Last Updated: March 31, 2017
Individual Participant Data  
Plan to Share IPD: Yes

Keywords provided by Karyopharm Therapeutics Inc:
PAK4
KPT-9274
Karyopharm
NHL
solid tumors

Additional relevant MeSH terms:
Niacin
Niacinamide
Nicotinic Acids
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 28, 2017