Cohort 1; 30 mg for Acute Myeloid Leukemia (AML) in Relapse

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Acute Myeloid Leukemia (AML) in Relapse+2 MoreKPT-9274 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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

Effectiveness Progress

1 of 3

Similar Trials

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: 28 days

28 days
Establish Recommended Phase 2 Dose (RP2D)
Maximum Tolerated Dose (MTD)

Trial Safety

Safety Progress

1 of 3

Similar Trials

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: Drug
Cohort 3; 60mg
Drug
ActiveComparator Group · 1 Intervention: KPT-9274 · Intervention Types: Drug
Cohort 5; 100mg
Drug
ActiveComparator Group · 1 Intervention: KPT-9274 · Intervention Types: Drug
Cohort 4; 80mg
Drug
ActiveComparator Group · 1 Intervention: KPT-9274 · Intervention Types: Drug
Cohort 2; 40mg
Drug
ActiveComparator Group · 1 Intervention: KPT-9274 · Intervention Types: Drug
De-escalation Cohort; 20mg
Drug
ActiveComparator Group · 1 Intervention: KPT-9274 · Intervention Types: Drug

Trial 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