Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:29 PM
Ignite Modification Date:
2025-12-24 @ 10:29 PM
NCT ID:
NCT03127735
Eligibility Criteria:
Inclusion Criteria:
* Patients with advanced AML that harbors IDH1 mutation
* Patients are relapsed from or refractory to at least 1 previous line of therapy
* Good kidney and liver function
* Male or female patients
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
* Women must have a negative serum pregnancy test within 7 days prior to the first dose of study drug or be surgically or biologically sterile or postmenopausal
Exclusion Criteria:
* Previously treated with any prior mIDH1 targeted therapy
* Extramedullary disease only
* History of clinically significant or active cardiac disease
* Active clinically significant infection
* Unresolved chronic toxicity of previous AML treatment
* Taking known strong cytochrome P450 (CYP) 2C8 inducers or inhibitors
* Pregnancy or breast-feeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03127735
Study Brief:
Protocol Section:
NCT03127735