A Study of APTO-253 in Patients With Relapsed or Refractory AML or MDS

Recruiting in Palo Alto (17 mi)

+12 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Aptose Biosciences Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?

This study is being done to evaluate the safety and effectiveness of APTO-253 for the treatment of patients with the condition of acute myelogenous leukemia (AML) or myelodysplastic syndrome (MDS) for which either the standard treatment has failed, is no longer effective, or can no longer be administered safely or poses a risk for your general well being.

Research Team

Rafael Bejar, MD., PhD.

Principal Investigator

Aptose Biosciences Inc.

Eligibility Criteria

Inclusion Criteria

Life expectancy of at least 2 months

Off previous cancer therapy for at least 14 days, or 5 half-lives for noncytotoxic agents prior to first study treatment administration

Patients must have a calculated creatinine clearance >60 mL/min

See 2 more

Treatment Details

Interventions

APTO-253 (Other)

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Dose Escalation and ExpansionExperimental Treatment1 Intervention

APTO-253 will be given in ascending doses in patients with relapsed or refractory AML or high risk MDS (escalation cohort), until the maximum tolerated dose or recommended dose is reached. Followed by up to 30 patients enrolled in the expansion cohort at the recommended dose.