PAK4 and NAMPT in Patients With Solid Malignancies or NHL (PANAMA) (NCT02702492) | Clinical Trial Compass
TerminatedPhase 1
PAK4 and NAMPT in Patients With Solid Malignancies or NHL (PANAMA)
Stopped: sponsor decision
United States60 participantsStarted 2016-06-08
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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:
✓. Adequate renal function:
✓. Adequate hematopoietic function:
Exclusion criteria
✕. ≤ 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.
What they're measuring
1
Maximum Tolerated Dose (MTD) for KPT-9274
Timeframe: From start of study drug administration up to 44 weeks
2
Number of Dose Limiting Toxicities (DLT) Experienced by Participants
Timeframe: At Cycle 1 only (28-day cycle)
3
Number of Participants With Adverse Event (AE) of Severity Grade >= 3 or 4, Serious AEs, and AEs Leading to Treatment Discontinuation
Timeframe: From start of study drug administration up to 49 weeks
4
Percentage of Participants With Overall Response Rate (ORR)
Timeframe: From date of randomization up to 44 weeks
5
Percentage of Participants With Disease Control Rate (DCR)
Timeframe: From date of the first study treatment up to 44 weeks
6
Progression-free Survival (PFS)
Timeframe: From the date of first study treatment until the first date of PD, or death due (up to 44 weeks)
7
Overall Survival (OS)
Timeframe: From date of the first study treatment until death (up to 44 weeks)
✕. 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.
Time to Progression (TTP)
Timeframe: From date of the first study treatment until the first date of PD or death (up to 44 weeks)