Spots Global Cancer Trial Database for Study of CB-5339 in Acute Myeloid Leukemia or Myelodysplastic Syndrome
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Trial Identification
Brief Title: Study of CB-5339 in Acute Myeloid Leukemia or Myelodysplastic Syndrome
Official Title: A Phase 1 Study to Evaluate the Safety and Pharmacokinetic Profiles of CB-5339 in Participants With Relapsed/Refractory Acute Myeloid Leukemia or Relapsed/Refractory Intermediate or High Risk Myelodysplastic Syndrome
Study ID: NCT04402541
Interventions
Study Description
Brief Summary: This is a multicenter, open-label Phase 1 study of orally administered CB-5339 in participants with R/R AML or participants with R/R intermediate- to high-risk MDS.
Detailed Description: This is a multicenter, open-label Phase 1 study of orally administered CB-5339 in participants with R/R AML or participants with R/R intermediate- to high-risk MDS. The study will include two parts:1) a Dose Escalation phase in participants with R/R AML, or R/R intermediate- to high-risk MDS and 2) a Dose Expansion phase in participants with R/R AML for whom there is no standard of care therapy available that is likely to lead to disease remission. Additional cohorts for participants with R/R intermediate- to high-risk MDS following hypomethylating agents or other AML cohorts may be added at a later time.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
USC Norris Comprehensive Cancer Center, Los Angeles, California, United States
KU Clinical Research Center, Fairway, Kansas, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Weill Cornel Medical Center, New York, New York, United States
Saint Francis Hospital Cancer Center, Greenville, North Carolina, United States
Cleveland Clinic, Case Comprehensive Cancer Center, Cleveland, Ohio, United States
MD Anderson Cancer Cancer, Houston, Texas, United States
St. Vincent Hospital, Sydney, NSW, Darlinghurst, New South Wales, Australia
Epworth Healthcare, Melbourne, Victoria, Australia
Haematology Clinical Trials Unit, Royal Perth Hospital, Perth, Western Australia, Australia
Contact Details
Name: Scott Harris
Affiliation: Cleave Therapeutics, Inc.
Role: STUDY_CHAIR
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