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

Stopped early · Phase 1

Conditions studied: Solid Tumors, NHL

In brief

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).

Key facts

Study ID

NCT02702492

Run by

Karyopharm Therapeutics Inc

People needed

60

Starts

2016-06-08

Expected to finish

2021-01-26

Last updated by the study team

2024-11-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants must meet all of the following inclusion criteria to be eligible to enroll in the Part C of this study.
• Should have unresectable advanced, recurrent or metastatic melanoma and must have objective and measurable melanoma by RECIST 1.1 after disease progression on a prior anti-PD-1 or anti-PD-L1 therapy.
• ECOG performance status of ≤ 2.
• Life expectancy of ≥ 3 months.
• Adequate hepatic function:
• Total bilirubin < 1.5 times the ULN (except participants with Gilbert's syndrome [hereditary indirect hyperbilirubinemia] who must have a total bilirubin of ≤ 3 times ULN),
• AST and ALT ≤ 2.5 times ULN (except participants with known liver involvement of their advanced solid malignancy who must have an AST and ALT ≤ 5.0 times ULN).
• Adequate renal function:
• Estimated creatinine clearance of ≥ 60 mL/min, calculated using the formula of Cockroft and Gault (140-Age) Mass (kg)/(72 creatinine mg/dL); multiply by 0.85 if female.
• Adequate hematopoietic function:
• Total WBC count ≥ 1500/mm³, ANC ≥ 1000/mm³, Hb ≥ 10.0 g/dL, platelet count ≥ 100,000/mm³

You may not qualify if…

• Participants meeting any of the following exclusion criteria are not eligible to enroll in this study.
• ≤ 2 weeks since the last prior therapeutic regimen for melanoma. Palliative steroids for disease related symptoms < 7 days prior to C1D1, unless physiologic doses of steroids are used.
• Have not recovered or stabilized (Gr 1 or to their baseline for non-hematologic toxicities, ≤ Gr 2 or to their baseline for hematologic toxicities) from toxicities related to their previous treatment except for alopecia.
• Untreated CNS disease or leptomeningeal involvement are excluded. Participants without active brain or leptomeningeal metastases after prior treatment with local therapies are eligible provided that the treatment had been done ≥ 2 weeks prior to enrollment.
• Active infection with completion of therapeutic antibiotics, antivirals, or antifungals within one week prior to C1D1. Prophylactic antibiotics, antivirals or antifungals are permitted.
• Significantly 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.
• Requiring treatment with corticosteroids at doses higher than substitute therapy (> 10 mg prednisone), are unstable with substitute hormonal therapy, or are deemed to be likely to re-occur by the treating physician when administered nivolumab.

Where it is running

• UCLA Health — Los Angeles, California, United States
• University of Colorado Cancer Center — Aurora, Colorado, United States
• Georgetown University, Lombardi Comprehensive Cancer Center — Washington D.C., District of Columbia, United States
• Mayo Clinic Rochester — Rochester, Minnesota, United States
• NYU-Laura & Isaac Perlmutter Cancer Center — New York, New York, United States
• Vanderbilt-Ingram Cancer Center — Nashville, Tennessee, United States
• MD Anderson Cancer Center — Houston, Texas, United States
• Princess Margaret Hospital — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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