Cancer drug pralsetinib may change how the body processes other medications

NCT ID NCT07704658

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 15, 2026 · Last updated Aug 11, 2026 · Updated 3 times

Summary

This study looks at how the cancer drug pralsetinib (Gavreto) affects the way the body breaks down other drugs and hormones. Researchers will give a cocktail of common medications and a hormone-based contraceptive to people with advanced solid tumors, then measure how pralsetinib changes their levels in the blood. The goal is to understand potential drug interactions, helping doctors prescribe pralsetinib more safely alongside other treatments.

What this could mean

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

Active substance
pralsetinib (Gavreto) and a cocktail of probe drugs (midazolam, repaglinide, losartan, estradiol/norethisterone acetate)
What this could lead to
If successful, this study could help doctors understand how pralsetinib interacts with other medications, leading to safer dosing guidelines for patients.
What could go wrong
This is a small, early-phase drug interaction study with only 12 participants, so results may not apply to all patients. The study does not test whether pralsetinib works against cancer.
Why investors are watching

Rigel Pharmaceuticals is running a Phase 4 study to see how its drug pralsetinib (Gavreto) interacts with other medicines and hormones in patients with certain solid tumors. For a small company, this readout matters because it will clarify how the drug behaves in the body, which can affect how doctors use it and how the drug is positioned in the market.

If it works: A positive result showing pralsetinib has manageable interactions could support broader use of the drug and reassure doctors about combining it with other treatments. That could strengthen Rigel's commercial prospects for Gavreto.

If it fails: If the study shows significant drug interactions or unexpected side effects, it could limit how the drug is prescribed and hurt Rigel's revenue from Gavreto. Trials often fail or reveal problems, so this outcome is a real risk.

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 12 people

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

Started

Mar 2026

Expected to finish

Aug 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: * Must be willing and able to participate and comply with all study requirements and to provide signed and dated written informed consent * Adult male or female ≥ 18 years of age at the time of signing the informed consent form. * Must have a body mass index (BMI) ≥ 18 and ≤ 32 kg/m² and a minimum body weight of 50 kg at screening. * 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 confirmed diagnosis of advanced or metastatic solid tumor that has relapsed after, or is not responsive to, standard therapies and harbors an oncogenic RET fusion or mutation as determined by a validated test. * Must have adequate organ function, defined by the following: 1. Absolute neutrophil count (ANC) ≥ 1.0 × 10⁹/L. 2. Platelet count ≥ 75 × 10⁹/L. 3. Hemoglobin ≥ 9 g/dL. 4. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × upper limit of normal (ULN), or ≤ 5 × ULN in patients with known liver metastases. 5. Total bilirubin ≤ 1.5 × ULN (≤ 3 × ULN in patients with Gilbert syndrome). 6. Creatinine clearance ≥ 40 mL/min using the Cockcroft-Gault equation. 7. Serum phosphorus ≤ 5.5 mg/dL. 8. International normalized ratio (INR), prothrombin time (PT), and activated partial thromboplastin time (aPTT) within normal laboratory limits. * Must be at least 4 weeks from major surgery, radiotherapy, chemotherapy, immunotherapy, kinase/targeted therapy, or gene therapy prior to the first dose of study treatment and recovered from treatment-related toxicities to ≤ Grade 1 (excluding alopecia). Must be ≥ 6 weeks since last treatment if they received a long-acting agent such as a nitrosourea, mitomycin, or monoclonal antibodies. In general, a treatment interval of two half-lives should be considered and discussed with the Sponsor. (Concurrent cancer therapy of any type is not permitted). * Female patients may participate if they are not of childbearing potential (e.g., surgically sterile or postmenopausal). * Male patients with female partners of childbearing potential must agree to use highly effective contraception during study treatment and for 90 days after the last dose of study treatment. * Male patients must refrain from sperm donation during study treatment and for 90 days after the last dose of study treatment. Exclusion Criteria: * Clinically relevant abnormal medical history, abnormal findings on physical examination, vital signs, electrocardiogram (ECG), or laboratory tests at screening that, in the investigator's judgment, are likely to interfere with the objectives of the trial or the safety of the patient. * Surgery (e.g., gastric bypass) or medical condition that may significantly affect absorption of study medications, as judged by the investigator. * History of pneumonitis within the last 12 months. * History of active or latent tuberculosis (TB), regardless of treatment history, or a positive screening test for latent Mycobacterium tuberculosis infection by QuantiFERON® TB Gold. Indeterminate results may be confirmed by repeat testing or by a purified protein derivative (PPD) skin test. * 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 safety (e.g., COVID-19 or influenza). * Clinically significant, uncontrolled cardiovascular disease, including: 1. New York Heart Association (NYHA) Class III or IV congestive heart failure. 2. Myocardial infarction or unstable angina within the previous 6 months, clinically significant uncontrolled arrhythmias, including bradyarrhythmias that may cause QT prolongation (e.g., second- or third-degree heart block). 3. Uncontrolled hypertension (i.e., mean systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥110 mmHg on 3 repeated measurements) or clinically significant hypotension (i.e., systolic blood pressure \<90 mmHg and/or diastolic blood pressure \<50 mmHg) or severe episodes of orthostatic hypotension. 4. History of prolonged QT syndrome or torsades de pointes, or familial history of long QT syndrome. 5. QTcF ≥470 ms on at least 2 ECGs performed \>30 minutes apart. * Central nervous system (CNS) metastases or primary CNS tumor. * Use of systemic corticosteroids within 4 weeks prior to first dose of study treatment. * More than 30 Gy of radiotherapy to the lung within 6 months prior to check-in. * History of multiple and/or severe allergies to drugs or foods, or history of severe anaphylactic reaction. * Use of prohibited medications or procedures * Medical conditions, treatments, or underlying diseases that constitute contraindications to the use of study substrates or probe drugs * Ingestion of alcohol within 72 hours prior to first study drug administration and during the study period. * Participation in another investigational drug trial within 30 days prior to study drug administration (or within 5 half-lives of the investigational drug, whichever is longer) or exposure to more than 3 investigational agents within 12 months prior to study drug administration. * Positive serology for hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibody at screening (a negative PCR test overrides a positive serology). * Positive human immunodeficiency virus (HIV) test at screening. * Positive urine drug screen (unless attributable to concomitant medication) or positive alcohol breath test at screening and/or Day -1. * Patients who are legally incapacitated, have limited legal capacity, or are otherwise considered vulnerable. * Female patients who are pregnant or breastfeeding. * Patients who plan to become pregnant or father a child (including ova or sperm donation) during the study or within 3 months after the last dose of study drug. * Known allergy or history of hypersensitivity to study drug(s) or their excipients. * Concomitant use of strong or moderate CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, and/or CYP3A4 inhibitors within 7 days or 5 half-lives (whichever is longer) prior to first dose of study treatment. * Concomitant use of strong or moderate CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, and/or CYP3A4 inducers within 14 days or 5 half-lives (whichever is longer) prior to first dose of study treatment. * History of or active clinically significant cardiovascular, respiratory, gastrointestinal, renal, hepatic, neurological, psychiatric, musculoskeletal, genitourinary, dermatologic, hematologic, or other disorder that, in the investigator's judgment, could interfere with study participation or the absorption, metabolism, or excretion of study treatment. * 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.

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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

  • Hospital Universitario HM Sanchinarro

    RECRUITING

    Madrid, 28050, Spain

  • Hospital Universitario San Pedro

    RECRUITING

    Logroño, La Rioja, 26006, Spain

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