Study Summary
This trial will study a new drug to treat patients with a certain type of leukemia that has returned or does not respond to other treatments.
Eligible Conditions
- Acute Myeloid Leukemia (AML) in Relapse
- Acute Myeloid Leukemia
- Refractory Acute Myelogenous Leukemia
Treatment Effectiveness
Study Objectives
1 Primary · 1 Secondary · Reporting Duration: 28 days
28 days
Establish Recommended Phase 2 Dose (RP2D)
Maximum Tolerated Dose (MTD)
Trial Safety
Trial Design
6 Treatment Groups
Cohort 1; 30 mg
1 of 6
Cohort 3; 60mg
1 of 6
Cohort 5; 100mg
1 of 6
Cohort 4; 80mg
1 of 6
Cohort 2; 40mg
1 of 6
De-escalation Cohort; 20mg
1 of 6
Active Control
40 Total Participants · 6 Treatment Groups
Primary Treatment: Cohort 1; 30 mg · No Placebo Group · Phase 1
Cohort 1; 30 mg
Drug
ActiveComparator Group · 1 Intervention: KPT-9274 · Intervention Types: DrugCohort 3; 60mg
Drug
ActiveComparator Group · 1 Intervention: KPT-9274 · Intervention Types: DrugCohort 5; 100mg
Drug
ActiveComparator Group · 1 Intervention: KPT-9274 · Intervention Types: DrugCohort 4; 80mg
Drug
ActiveComparator Group · 1 Intervention: KPT-9274 · Intervention Types: DrugCohort 2; 40mg
Drug
ActiveComparator Group · 1 Intervention: KPT-9274 · Intervention Types: DrugDe-escalation Cohort; 20mg
Drug
ActiveComparator Group · 1 Intervention: KPT-9274 · Intervention Types: DrugTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 28 days
Who is running the clinical trial?
Karyopharm Therapeutics IncIndustry Sponsor
84 Previous Clinical Trials
8,096 Total Patients Enrolled
University of Colorado, DenverLead Sponsor
1,594 Previous Clinical Trials
1,927,356 Total Patients Enrolled
Daniel Pollyea, MDPrincipal InvestigatorUniversity of Colorado, Denver
4 Previous Clinical Trials
129 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 9 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You must give written consent before taking part in any study procedures that are not necessary for your health
Some patients with a certain kind of leukemia who have not responded to or relapsed after at least one prior therapy and for whom no standard therapy that may provide clinical benefit is available.
A person has total bilirubin levels that are less than 1.5 times the upper limit of normal, with the exception of people who have Gilbert's syndrome
The patient has a performance status of ≤ 2, which is indicative of a less-than-optimal health status.
AST and ALT levels must be less than or equal to 2.5 times the upper limit of normal (except for patients with known liver involvement of their AML who must have AST and ALT levels less than or equal to 5.0 times the upper limit of normal).
All female patients of child-bearing potential must agree to use two methods of contraception (one highly effective and one effective) and have a negative serum pregnancy test at Screening
Patients who are sexually active with a partner who can become pregnant must use effective contraception methods throughout the study and for 3 months after the last dose.
The subject has adequate renal function if their creatinine clearance is ≥ 60 mL/min, calculated using the Cockcroft-Gault formula
References
- Jones, Courtney L., Brett M. Stevens, Daniel A. Pollyea, Rachel Culp-Hill, Julie A. Reisz, Travis Nemkov, Sarah Gehrke, et al.. 2020. “Nicotinamide Metabolism Mediates Resistance to Venetoclax in Relapsed Acute Myeloid Leukemia Stem Cells”. Cell Stem Cell. Elsevier BV. doi:10.1016/j.stem.2020.07.021.
- 2021. "KPT-9274 in Patients With Relapsed and Refractory Acute Myeloid Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04914845.
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Conditions
Cancer Related
Treatments