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 States, Canada60 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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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)
. ≤ 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.
Timeframe: From date of the first study treatment until death (up to 44 weeks)
8
Time to Progression (TTP)
Timeframe: From date of the first study treatment until the first date of PD or death (up to 44 weeks)