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



Status:Recruiting
Conditions:Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/3/2019
Start Date:June 2016
End Date:November 2019
Contact:Jatin Shah, MD
Email:jshah@karyopharm.com

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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

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).

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.

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.
We found this trial at
7
sites
2220 Pierce Ave
Nashville, Tennessee 37232
615-936-8422
Principal Investigator: Jordan Berlin, MD
Vanderbilt-Ingram Cancer Center The Vanderbilt-Ingram Cancer Center, located in Nashville, Tenn., brings together the clinical...
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Aurora, Colorado 80045
Principal Investigator: Stephen Leong, MD
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Houston, Texas 77030
Principal Investigator: Aung Naing, MD
Phone: 713-563-0803
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Houston, TX
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160 East 34th Street
New York, New York 10001
Principal Investigator: Daniel Cho, MD
Phone: 212-731-5871
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200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Principal Investigator: Amit Mahipal, MBBS, MPH
Phone: 507-293-0462
Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
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Toronto, Ontario
Principal Investigator: Albiruni Razak, MB, Bch
Phone: 416-586-4800
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Washington, District of Columbia 20007
Principal Investigator: Michael Pishvaian, MD, PhD
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Washington,
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