AML (Acute Myeloid Leukemia)Phase 4NCT07486713
Olutasidenib DDI Study in Patients With IDH1 Mutation Positive Malignancies
A Phase 4 study testing Olutasidenib and CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP3A4, and OATP1B1 Probe Substrates in people with AML (Acute Myeloid Leukemia) and Glioma, run by Rigel Pharmaceuticals at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- AML (Acute Myeloid Leukemia), Glioma, Cholangiocarcinoma
- What is being tested?
- Olutasidenib and CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP3A4, and OATP1B1 Probe Substrates
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 2 sitesUnited States
- Study dates
- 23 Feb 2026to 30 Jun 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to 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 prior to the first dose of study drug.
- 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).
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- 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 within the 24-hour period prior to the first dose of study drug. WOCBP are defined as sexually mature women without prior hysterectomy or who have had any evidence of menses in the past 12 months. However, women who have been amenorrheic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, anti-estrogens, or ovarian suppression.
- 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 treatment.
- 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.
Who cannot join
- 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.
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- 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 patient's safety (e.g. COVID-19).
- 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 opinion (or following review by the Sponsor), could affect the conduct of the study or the absorption, metabolism or excretion of the study treatment.
- 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 or antibody therapies, a minimum of 6 weeks.
- 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 low grade, early-stage prostate cancer (Gleason score 6 or below, stage 1 or 2) with no requirement for therapy at any time prior to the study, or previously resected are also eligible.
- 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 therapeutic intervention, palliative care, surgery or radiation therapy.
- 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 correction formula.
- Patients with New York Heart Association Class III or IV heart failure.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
New York Presbyterian Hospital-Columbia University Medical Center
New York, New York, 10032
- Recruiting
UCI Irvine Health
Orange, California, 92868
About this study
Official title: A Multi-Center, Open-Label, Drug-Drug Interaction Study to Evaluate the Effect of Olutasidenib on the Pharmacokinetics of CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP3A4, and OATP1B1 Substrates in Patients With IDH1 Mutation-Positive Malignancies Being Treated With Olutasidenib
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.
- Being tested
- Olutasidenib, CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP3A4, and OATP1B1 Probe Substrates
- Keywords
- IDH1 Mutation, Hematology and Oncology, Oncology, Drug-Drug Interactions
- Medical subject headings
- Leukemia, Myeloid, Acute, Glioma, Cholangiocarcinoma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OlutasidenibDrug
Participants will receive repeated dosing of olutasidenib from Day 5 to Day 22 until steady state, with an option to continue treatment up to Day 64
CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP3A4, and OATP1B1 Probe SubstratesDrug
Participants will receive a single dose of each probe substrate on Day 1 and Day 18.
| Study group | Role | What they receive |
|---|---|---|
| Olutasidenib, CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP3A4, and OATP1B1 Substrates | Experimental | Participants will receive olutasidenib twice daily from Day 5 to Day 22.
Participant will also receive a single dose of CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP3A4, and OATP1B1 probe substrates on Day 1 and Day 18. Receives: Drug: Olutasidenib; Drug: CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP3A4, and OATP1B1 Probe Substrates |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Plasma Concentration-Time Curve (AUC) of Probe Drugs
To evaluate how olutasidenib affects the overall exposure of several test drugs (probe substrates) that are used to measure the activity of certain enzymes (CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP3A4) and a drug transporter (OATP1B1). This will be assessed by measuring the area under the plasma concentration-time curve after the probe drugs are taken alone and again after treatment with olutasidenib.
Measured: Up to 96 hours after each probe drug administration.
Maximum Plasma Concentration (Cmax) of Probe Drugs
To evaluate how olutasidenib affects the peak levels of probe drugs in the blood after they are taken alone and again after treatment with olutasidenib.
Measured: Up to 96 hours after each probe drug administration.
Secondary outcomes (7)
Time to Maximum Plasma Concentration (Tmax) of Probe Drugs
To assess how olutasidenib affects the time required to reach peak plasma concentration for each probe drug.
Measured: Up to 96 hours after each probe drug administration
Elimination Half-Life (t½) of Probe Drugs
To evaluate the effect of olutasidenib on the terminal elimination half-life of each probe drug.
Measured: Up to 96 hours after each probe drug administration
Percent of Area Under the Curve Extrapolated (%AUCex) of Probe Drugs
To determine the proportion of the AUC that is extrapolated, providing insight into olutasidenib's effect on drug elimination.
Measured: Up to 96 hours after each probe drug administration
Elimination Rate Constant (λz) of Probe Drugs
To assess how olutasidenib affects the terminal elimination rate constant of each probe drug.
Measured: Up to 96 hours after each probe drug administration
Apparent Total Body Clearance (CL/F) of Probe Drugs
To evaluate the effect of olutasidenib on the apparent total body clearance of each probe drug.
Measured: Up to 96 hours after each probe drug administration
Apparent Volume of Distribution (Vz/F) of Probe Drugs
To assess how olutasidenib influences the apparent volume of distribution of each probe drug.
Measured: Up to 96 hours after each probe drug administration
Incidence, Frequency, and Severity of Treatment-Emergent Adverse Events (TEAEs) with Olutasidenib and Probe Substrates
To assess the safety and tolerability of olutasidenib co-administered with a cocktail of drugs metabolized/transported by CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, and CYP3A4, or transported by OATP1B1
Measured: From the start of treatment through approximately 30 days after the last dose of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2026
- Study start23 Feb 2026
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AML (Acute Myeloid Leukemia)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rigel Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07486713
- Sponsor's protocol ID
- C-002102-003
- Status last verified
- Aug 2026
- First submitted
- 12 Mar 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Open-Label, Drug-Drug Interaction Study to Evaluate the Effect of Olutasidenib on the Pharmacokinetics of CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP3A4, and OATP1B1 Substrates in Patients With IDH1 Mutation-Positive Malignancies Being Treated With Olutasidenib
- ClinicalTrials.gov ID
- NCT07486713
- Acronym / sponsor ID
- C-002102-003
- Keywords
- IDH1 Mutation, Hematology and Oncology, Oncology, Drug-Drug Interactions
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Rigel PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 23 Feb 2026 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 20 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Olutasidenib, CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP3A4, and OATP1B1 Substrates | Experimental | Drug: Olutasidenib, Drug: CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP3A4, and OATP1B1 Probe SubstratesParticipants will receive olutasidenib twice daily from Day 5 to Day 22. Participant will also receive a single dose of CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP3A4, and OATP1B1 probe substrates on Day 1 and Day 18. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
- Patient must have an adequate organ function, defined by the following:
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OlutasidenibParticipants will receive repeated dosing of olutasidenib from Day 5 to Day 22 until steady state, with an option to continue treatment up to Day 64 | Drug | Olutasidenib, CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP3A4, and OATP1B1 Substrates |
| CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP3A4, and OATP1B1 Probe SubstratesParticipants will receive a single dose of each probe substrate on Day 1 and Day 18. | Drug | Olutasidenib, CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP3A4, and OATP1B1 Substrates |
Primary outcome
Area Under the Plasma Concentration-Time Curve (AUC) of Probe Drugs
Time frame: Up to 96 hours after each probe drug administration.
To evaluate how olutasidenib affects the overall exposure of several test drugs (probe substrates) that are used to measure the activity of certain enzymes (CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP3A4) and a drug transporter (OATP1B1). This will be assessed by measuring the area under the plasma concentration-time curve after the probe drugs are taken alone and again after treatment with olutasidenib.
Maximum Plasma Concentration (Cmax) of Probe Drugs
Time frame: Up to 96 hours after each probe drug administration.
To evaluate how olutasidenib affects the peak levels of probe drugs in the blood after they are taken alone and again after treatment with olutasidenib.
7 secondary outcomes
Time to Maximum Plasma Concentration (Tmax) of Probe Drugs
Time frame: Up to 96 hours after each probe drug administration
Elimination Half-Life (t½) of Probe Drugs
Time frame: Up to 96 hours after each probe drug administration
Percent of Area Under the Curve Extrapolated (%AUCex) of Probe Drugs
Time frame: Up to 96 hours after each probe drug administration
Elimination Rate Constant (λz) of Probe Drugs
Time frame: Up to 96 hours after each probe drug administration
Apparent Total Body Clearance (CL/F) of Probe Drugs
Time frame: Up to 96 hours after each probe drug administration
Apparent Volume of Distribution (Vz/F) of Probe Drugs
Time frame: Up to 96 hours after each probe drug administration
Incidence, Frequency, and Severity of Treatment-Emergent Adverse Events (TEAEs) with Olutasidenib and Probe Substrates
Time frame: From the start of treatment through approximately 30 days after the last dose of study treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Olutasidenib and CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP3A4, and OATP1B1 Probe Substrates in people with AML (Acute Myeloid Leukemia) and Glioma, run by Rigel Pharmaceuticals at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kay Patel ((650) 624-1100, kpatel@rigel.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area Under the Plasma Concentration-Time Curve (AUC) of Probe Drugs (time frame: Up to 96 hours after each probe drug administration.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.