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

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ClinicalTrials.gov Identifier: NCT02702492
Recruitment Status : Recruiting
First Posted : March 8, 2016
Last Update Posted : October 2, 2018
Sponsor:
Information provided by (Responsible Party):
Karyopharm Therapeutics Inc

Brief Summary:
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 or disease Intervention/treatment Phase
NHL Solid Tumors Drug: KPT-9274 Drug: KPT-9274 & Niacin ER Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 175 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
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
Actual Study Start Date : June 2016
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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 Extended Release (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



Primary Outcome Measures :
  1. Dose Limiting Toxicities (DLT) [ Time Frame: From first dose through Cycle 1 - 28 days. ]
    Evaluate dose limiting toxicities of KPT-9274



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02702492


Contacts
Contact: Jatin Shah, MD jshah@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: Jatin Shah, MD Karyopharm Therapeutics Inc

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
First Posted: March 8, 2016    Key Record Dates
Last Update Posted: October 2, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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

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