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New study checks if cancer drug olutasidenib changes how other medicines work

NCT ID NCT07486713

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 12, 2026 · Updated 3 times

Summary

This study looks at how the cancer drug olutasidenib affects the way the body processes other medications. Researchers will give 16 adults with IDH1-mutated cancers a mix of test drugs before and during olutasidenib treatment to measure changes in drug levels. The goal is to ensure safe and effective dosing when olutasidenib is used alongside other medicines.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Olutasidenib
What this could lead to
If successful, this study could help doctors understand how olutasidenib interacts with other medications, leading to safer treatment plans for patients with IDH1-mutated cancers.
What could go wrong
This is a small, early-phase drug interaction study, not designed to test whether olutasidenib works against cancer. Results may not apply to all patients or predict real-world outcomes.
Why investors are watching

Rigel Pharmaceuticals is running a Phase 4 study to see how its cancer drug olutasidenib affects the way the body processes other medications. The trial tests the drug against a cocktail of common metabolic pathways in 16 patients with IDH1-mutated cancers. For a small company, this readout matters because it clarifies how olutasidenib interacts with other drugs, which can affect its safety label and how doctors use it in practice.

If it works: A clean result showing no major interactions could support broader use of olutasidenib alongside other medicines, potentially widening its patient pool. It could also strengthen the drug's regulatory profile and reassure prescribers.

If it fails: If the study shows significant interactions, doctors may need to adjust dosing or avoid certain combinations, which could limit how olutasidenib is used. The trial could also fail to enroll enough patients or produce unclear data, and small studies like this often do not change the drug's commercial outlook.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 16 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2026

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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). * 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. Exclusion Criteria: * 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 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: 1. 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. 2. 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • New York Presbyterian Hospital-Columbia University Medical Center

    RECRUITING

    New York, New York, 10032, United States

  • UCI Irvine Health

    RECRUITING

    Orange, California, 92868, United States

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