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New treatment option for AML (Acute Myeloid Leukemia)
Official title Olutasidenib DDI Study in Patients With IDH1 Mutation Positive Malignancies
ClinicalTrials.gov ID: NCT07486713
What this study is testing
What is Olutasidenib?
Olutasidenib is an investigational medicine, being studied as a potential treatment for aml (acute myeloid leukemia).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Must have a diagnosis of IDH1m+ malignancy to be treated with olutasidenib (e.g. acute myeloid leukemia [AML], gastrointestinal [GI] cancers...
- Patient must have an adequate organ function, defined by the following:
You likely can't join if
- 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...
- Known allergy or history of hypersensitivity to study drugs or their excipients.
- Human immunodeficiency virus (HIV) positivity.
See the full eligibility criteria
Who can join
- 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...
- Patient must have an adequate organ function, defined by the following:
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) values ≤ 2.5 × upper limit of normal (ULN).
- Bilirubin ≤ 1.5× ULN (≤ 3 × ULN in patients with Gilbert Syndrome) or ≤ 3 × ULN for patients with AML involvement.
- Creatinine clearance ≥ 30 mL/min using Cockcroft-Gault equation.
- Female patients who are women of childbearing potential (WOCBP) must have a negative serum (β-hCG) pregnancy test at screening and negative urine test (positive urine tests are to be confirmed by serum test) documented...
- WOCBP, must agree to use two methods of birth control (e.g. hormonal and a barrier method such as a condom), or must be considered highly unlikely to conceive during the dosing period and for 3 months after last study...
- Male patients with female partners of childbearing potential may be enrolled if they both agree to use highly effective methods of contraception during the dosing period and for 3 months after last study treatment.
- Male patients must refrain from donating sperm during the dosing period and for 3 months after last study treatment.
What rules you out
- 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.
- Known allergy or history of hypersensitivity to study drugs or their excipients.
- Human immunodeficiency virus (HIV) positivity.
- Positive serology for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody or by RNA polymerase chain reaction (PCR) at screening.
- Any patient's with a serious infection requiring intravenous or systemic antibiotics within 7 days prior to initiation of study treatment, or any active infection that, in the opinion of the Investigator, could impact...
- Use of concomitant medications that are moderate or strong CYP1A2, 2B6, 2C8, 2C9, 2C19, and/or 3A4 inhibitors within 14 days or 5 half-lives (whichever is longer) prior to the first dose of study drug
- Use of concomitant medications that are moderate or strong CYP1A2, 2B6, 2C8, 2C9, 2C19, and/or 3A4 inducers within 14 days or 5 half-lives (whichever is longer) prior to the first dose of study drug.
- History of or active, clinically significant, cardiovascular, respiratory, GI, renal, hepatic, neurological, psychiatric, musculoskeletal, genitourinary, dermatological, or other disorder that, in the Investigator's...
- If less than the minimum time has elapsed from prior anticancer treatment to first dose of study treatment as follows:
- Cancer therapies, including chemotherapy, radiation, biologics or kinase inhibitors, or major surgery within 4 weeks prior to the first scheduled study treatment; for longer acting agents such as nitrosourea, mitomycin...
- Use of investigational agents within 4 weeks prior to study enrollment (within 6 weeks if the treatment was with a long-acting agent).
- History of prior second malignancy unless disease-free for ≥ 12 months or considered surgically cured. Patients with nonmelanoma skin cancers or with carcinomas in situ at any time following curative intent surgery and...
- Patients with symptomatic central nervous system metastases or other tumor location (such as spinal cord compression, other compressive mass, uncontrolled painful lesion, bone fracture, etc.) necessitating an urgent...
- Marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval \> 480 milliseconds [msec]) (Common Terminology Criteria for Adverse Events [CTCAE] Grade 1) using Fridericia's QT...
- Patients with New York Heart Association Class III or IV heart failure.
The study team makes the final eligibility decision.
Where it's taking place
- Orange, California, United States
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Orange, California, United States; New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.