AZD6738 for Myelodysplastic Syndrome
Trial Summary
What is the purpose of this trial?
This research study is studying a research drug called AZD6738 as a possible treatment for Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia .
Will I have to stop taking my current medications?
The trial requires a washout period (time without taking certain medications) of 5 half-lives for potent inhibitors or inducers of CYP3A4 before starting AZD6738, or three weeks for St. John's Wort. For other medications, the decision will be made on a case-by-case basis with the study doctor.
How is the drug AZD6738 (Ceralasertib) unique for treating myelodysplastic syndrome?
AZD6738 (Ceralasertib) is unique because it targets specific pathways involved in DNA damage response, which is different from other treatments that often focus on inhibiting blood vessel growth or targeting specific mutations. This novel approach may offer a new option for patients with myelodysplastic syndrome who have limited treatment choices.12345
Research Team
Andrew M Brunner, MD
Principal Investigator
Massachusetts General Hospital
Eligibility Criteria
Adults diagnosed with Myelodysplastic Syndrome (MDS) or Chronic Myelomonocytic Leukemia (CMML) who have not responded to, or cannot tolerate, certain chemotherapy treatments. They should be in a stable condition without acute leukemia and must not have other active cancers. Participants need functioning major organs and agree to use contraception.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive AZD6738 orally on a 28-day cycle to evaluate safety, tolerability, and effect on tumor growth
Follow-up
Participants are monitored for safety and effectiveness after treatment, including overall response rate and survival rates
Treatment Details
Interventions
- AZD6738
Find a Clinic Near You
Who Is Running the Clinical Trial?
Massachusetts General Hospital
Lead Sponsor
AstraZeneca
Industry Sponsor
Sir Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Dr. Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology