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RecruitingLast updated:15 August 2023

KRT-232-104: This Phase I/II trial is trying determine the effectiveness of a targeted therapy drug (KRT-232) in combination with chemotherapy (cytarabine and decitabine) in people adults with acute myeloid leukaemiaAn Open-Label, Multicenter, Phase 1b/2 Study of the Safety and Efficacy of KRT-232 Combined With Low-Dose Cytarabine (LDAC) or Decitabine in Patients With Acute Myeloid Leukemia (AML)

Clinical summary

Summary

This is a non-randomised trial with three experimental arms. In Experimental Arm 1, participants will receive KRT-232+LDAC. KRT-232 will be administered orally, once daily (QD), on Days 1-7 in combination with LDAC administered at 20 mg/m2/day subcutaneously on Days 1-10 in a 28-day cycle. In Experimental Arm 2, participants will receive KRT-232 (7-Day) + Decitabine. KRT-232 will be administered orally, once daily (QD), on Days 1-7 in combination with Decitabine administered at 20 mg/m2/day intravenously on Days 1-5 in a 28-day cycle. In Experimental Arm 3, participants will receive KRT-232 (14-Day) + Decitabine. KRT-232 will be administered orally, once daily (QD), on Days 1-7 and Days 15-21 (7 days on/7 days off/7 days on/7 days off) in combination with Decitabine administered at 20 mg/m2/day intravenously on Days 1-5 in a 28-day cycle.

Age

People18+

Phase

I/II

Trial Acronym

KRT-232-104

More information

Trial Identifiers

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Commercial Sponsor

Kartos Therapeutics, Inc.

Scientific Title

An Open-Label, Multicenter, Phase 1b/2 Study of the Safety and Efficacy of KRT-232 Combined With Low-Dose Cytarabine (LDAC) or Decitabine in Patients With Acute Myeloid Leukemia (AML)

Eligibility

Inclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.

Exclusion

  • You are able to swallow medication by mouth.
  • You have been diagnosed with cancer, but have not received any treatment.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
Message

Clinical trials have complex eligibility criteria.

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