Olutasidenib DDI Study in Patients With IDH1 Mutation Positive Malignancies
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorRigel Pharmaceuticals
About this trial
A open-label drug-drug interaction (DDI) study to evaluate the effects of olutasidenib on the pharmacokinetics (PK) of a CYP450 and OATP1B1 probe substrate cocktail in participants with IDH1 mutation-positive malignancies.
Eligibility criteria
Qualifiers
Adult male or female ≥ 18 years of age at the time of signing the informed consent form
Must have an Eastern Cooperative Oncology Group performance status ≤ 2.
Must have recovered from the non-hematologic toxic effects of prior treatment to Grade ≤ 1, or baseline value (excluding infertility, alopecia, or Grade 1 neuropathy)
Must have a diagnosis of IDH1m+ malignancy to be treated with olutasidenib (e.g. acute myeloid leukemia [AML], gastrointestinal [GI] cancers, glioma). Patient should not have received olutasidenib within the 2 weeks prior to the first dose of study drug.
Disqualifiers
Female patients who are pregnant or breastfeeding.
Patients who are active smokers. Those who have ceased smoking > 1 month before the Screening Visit will be allowed.
Ingestion of alcohol within 72 hours prior to first study drug administration and during the study period.
Any patient's who plans to become pregnant or father a child (including ova or sperm donation) while enrolled in this study or within 3 months after last dose of study drug.
Trial design
Treatments tested in this trial
- Olutasidenib
- CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP3A4, and OATP1B1 Probe Substrates
Treatment groups
16 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov