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About
To learn if olutasidenib can help to control CCUS, MDS, and/or CMML. The safety of the drug will also be studied.
Full description
Primary Objectives - To determine the response rate of olutasidenib monotherapy in patients with IDH1-mutated CCUS or lower-risk MDS/CMML
Secondary Objectives
Exploratory Objectives
Enrollment
Sex
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Volunteers
Inclusion criteria
Pathologically proven CCUS or lower-risk MDS/CMML
Patients must have a documented IDH1 mutation with VAF ≥ 0.02
Patients ≥ 18 years old
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 (Appendix A)
Acceptable liver function
Acceptable renal function with serum creatinine ≤ 1.5 times ULN or calculated creatinine clearance ≥ 50 mL/min (as assessed by Cockcroft-Gault, MDRD, or CKD-Epi validated measures)
Negative serum or urine pregnancy test if female of childbearing potential
For fertile men and women, agreement to use highly effective contraceptive methods for the duration of study participation and 90 days after the last dose of study medication. Appropriate highly effective method(s) of contraception include oral or injectable hormonal birth control, intrauterine device (IUD), and double barrier methods (for example a condom in combination with a spermicide)
Agreement for male patients not to donate sperm and for female patients of childbearing potential not to donate ova during the study and for 90 days after the final dose of study drug
Ability and willingness to signed informed consent prior to beginning study and undergoing procedures
Exclusion criteria
Patients unable to swallow oral medications, or patients with gastrointestinal conditions (e.g., malabsorption, resection, etc.) deemed by the Investigator to jeopardize intestinal absorption
Patients with any concurrent uncontrolled clinically significant medical condition, including life-threatening severe infection or psychiatric illness, which could place the patient at unacceptable risk of study treatment
Known active hepatitis B (HBV) or hepatitis C (HCV) or HIV infection
Pregnant or nursing women or women of childbearing potential not using highly effective contraception; male patients not using highly effective contraception as defined in the inclusion criteria
Subject with white blood cell count > 25 x109
/L Note: hydroxyurea use is permitted to meet this criterion with no washout required
Unwillingness or inability to comply with procedures either required in this protocol or considered standard of care.
Primary purpose
Allocation
Interventional model
Masking
15 participants in 1 patient group
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Central trial contact
Kelly Chien, MD
Data sourced from clinicaltrials.gov
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