NSCLC (Non-small Cell Lung Cancer)Phase 4NCT07704658
Pralsetinib DDI Study in Patients With Advanced or Metastatic Solid Tumors
A Phase 4 study testing Pralsetinib and CYP3A4, CYP2C8, and CYP2C9 substrates, and hormonal contraceptive in people with NSCLC (Non-small Cell Lung Cancer) and Thyroid Cancer, run by Rigel Pharmaceuticals at 2 sites in Spain.
Trial summary
An open-label drug-drug interaction study to evaluate the effects of pralsetinib (Gavreto) on the pharmacokinetics of a CYP450 probe substrate cocktail and, in female participants, a hormonal probe substrate, in participants with rearranged during transfection (RET) fusion- or mutation-positive solid tumors Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC (Non-small Cell Lung Cancer), Thyroid Cancer, Solid Tumor Malignancies
- What is being tested?
- Pralsetinib and CYP3A4, CYP2C8, and CYP2C9 substrates, and hormonal contraceptive
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesSpain
- Study dates
- 4 Mar 2026to 30 Aug 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
- 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.
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- Must have adequate organ function, defined by the following:
- Absolute neutrophil count (ANC) ≥ 1.0 × 10⁹/L.
- Platelet count ≥ 75 × 10⁹/L.
- Hemoglobin ≥ 9 g/dL.
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × upper limit of normal (ULN), or ≤ 5 × ULN in patients with known liver metastases.
- Total bilirubin ≤ 1.5 × ULN (≤ 3 × ULN in patients with Gilbert syndrome).
- Creatinine clearance ≥ 40 mL/min using the Cockcroft-Gault equation.
- Serum phosphorus ≤ 5.5 mg/dL.
- 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.
Who cannot join
- 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:
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- New York Heart Association (NYHA) Class III or IV congestive heart failure.
- 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).
- 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.
- History of prolonged QT syndrome or torsades de pointes, or familial history of long QT syndrome.
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain2 sites, 2 recruiting
- Recruiting
Hospital Universitario San Pedro
Logroño, La Rioja, 26006
Maria De Miguel, MD, PhD, MBA, maria.demiguel@startrioja.com
- Recruiting
Hospital Universitario HM Sanchinarro
Madrid, 28050
Irene Moreno, MD, irene.moreno@startmadrid.com
About this study
Official title: A Multi-center, Open-label, Drug-drug Interaction Study to Evaluate the Effect of Pralsetinib (Gavreto) on the Pharmacokinetics of CYP3A4, CYP2C8, and CYP2C9 Substrates, and Hormones Estradiol/Norethisterone Acetate in Patients With Advanced or Metastatic Solid Tumors
An open-label drug-drug interaction study to evaluate the effects of pralsetinib (Gavreto) on the pharmacokinetics of a CYP450 probe substrate cocktail and, in female participants, a hormonal probe substrate, in participants with rearranged during transfection (RET) fusion- or mutation-positive solid tumors
- Conditions
- NSCLC (Non-small Cell Lung Cancer), Thyroid Cancer, Solid Tumor Malignancies, Advanced Malignancies
- Being tested
- Pralsetinib, CYP3A4, CYP2C8, and CYP2C9 substrates, and hormonal contraceptive
- Keywords
- Oncology, Drug-Drug Interactions, Medical Oncology, RET Fusion Positive, RET Gene Mutation, Pharmacokinetic (PK)
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Thyroid Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PralsetinibDrug
Pralsetinib 400mg orally (PO) once daily (QD) from Day 4 to Day 10, with an option to continue up to Day 33
CYP3A4, CYP2C8, and CYP2C9 substrates, and hormonal contraceptiveDrug
Midazolam, repaglinide, and losartan (CYP probe substrates) and, for female participants, estradiol/norethisterone acetate (hormonal probe substrate), administered orally (PO) once on Day 1 and once on Day 9.
| Study group | Role | What they receive |
|---|---|---|
| Pralsetinib with CYP450 Probe Substrates and Hormonal Contraceptive | Experimental | Not described Receives: Drug: Pralsetinib; Drug: CYP3A4, CYP2C8, and CYP2C9 substrates, and hormonal contraceptive |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Plasma Concentration-Time Curve from zero to infinity (AUC0-inf)
To evaluate the effect of pralsetinib on the overall exposure of CYP3A4, CYP2C8, and CYP2C9, probe substrates, and hormonal contraceptive by measuring AUC0-inf for each probe substrate and its relevant metabolites.
Measured: Up to 48 hours post-dose or as appropriate for each probe substrate
Area under the plasma concentration-time curve from time zero to time of last measurable concentration (AUClast)
To evaluate the effect of pralsetinib on the overall exposure of CYP3A4, CYP2C8, and CYP2C9 probe substrates, and hormonal contraceptive by measuring AUClast for each probe substrate and its relevant metabolites.
Measured: Up to 48 hours after each probe drug administration
Maximum Peak Plasma Concentration (Cmax)
To evaluate how pralsetinib affects the peak levels of probe substrates, and hormonal contraceptive, in the blood after they are taken alone and again after treatment with pralsetinib
Measured: Up to 48 hours after each probe drug administration
Secondary outcomes (8)
Time to Maximum Plasma Concentration (tmax)
Venous whole blood samples will be collected for activity-based pharmacokinetics characterization to assess how pralsetinib affects the time required to reach peak plasma concentration for each probe drug.
Measured: Up to 48 hours after each probe drug administration
Terminal Half-Life (t½)
Venous whole blood samples will be collected for activity-based pharmacokinetics characterization To evaluate the effect of pralsetinib on the terminal half-life of each probe drug
Measured: Up to 48 hours after each probe drug administration
Percent of Area Under the plasma concentration-time curve obtained at extrapolation (%AUCex)
Venous whole blood samples will be collected for activity-based pharmacokinetics characterization to determine the proportion of the AUC that is extrapolated, providing insight into pralsetinib's effect on drug elimination
Measured: Up to 48 hours after each probe drug administration
Mean residence time (MRT)
Venous whole blood samples will be collected for activity-based pharmacokinetics characterization to assess how pralsetinib affects the average time each probe drug remains in the body
Measured: Up to 48 hours after each probe drug administration
Terminal Elimination Rate Constant (λz)
Venous whole blood samples will be collected for activity-based pharmacokinetics characterization to assess how pralsetinib affects the terminal elimination rate constant of each probe drug
Measured: Up to 48 hours after each probe drug administration
Apparent Total Body Clearance (CL/F)
Venous whole blood samples will be collected for activity-based pharmacokinetics characterization to evaluate the effect of pralsetinib on the apparent total body clearance of each probe drug
Measured: Up to 48 hours after each probe drug administration
Apparent Volume of Distribution (Vz/F)
Venous whole blood samples will be collected for activity-based pharmacokinetics characterization to assess how pralsetinib influences the apparent volume of distribution of each probe drug
Measured: Up to 48 hours after each probe drug administration
Safety and Tolerability
Incidence, frequency, relatedness, and severity of treatment-emergent adverse events (TEAEs) associated with co-administration of pralsetinib and probe substrates
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 posted15 Jul 2026
- Study start4 Mar 2026
- Primary completion30 Jul 2027 (estimated)
- Study completion30 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLC (Non-small Cell Lung Cancer)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
- 12 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
- NCT07704658
- Sponsor's protocol ID
- RGL-RET-001
- Status last verified
- Aug 2026
- First submitted
- 9 Jul 2026
- Last updated
- 10 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 10 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 Pralsetinib (Gavreto) on the Pharmacokinetics of CYP3A4, CYP2C8, and CYP2C9 Substrates, and Hormones Estradiol/Norethisterone Acetate in Patients With Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT07704658
- Acronym / sponsor ID
- RGL-RET-001
- Conditions
- NSCLC (Non-small Cell Lung Cancer), Thyroid Cancer, Solid Tumor Malignancies, Advanced Malignancies
- Keywords
- Oncology, Drug-Drug Interactions, Medical Oncology, RET Fusion Positive, RET Gene Mutation, Pharmacokinetic (PK)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Rigel PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 4 Mar 2026 (actual)
- Primary completion
- 30 Jul 2027 (estimated)
- Study completion
- 30 Aug 2027 (estimated)
- First posted
- 15 Jul 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.
An open-label drug-drug interaction study to evaluate the effects of pralsetinib (Gavreto) on the pharmacokinetics of a CYP450 probe substrate cocktail and, in female participants, a hormonal probe substrate, in participants with rearranged during transfection (RET) fusion- or mutation-positive solid tumors
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pralsetinib with CYP450 Probe Substrates and Hormonal Contraceptive | Experimental | Drug: Pralsetinib, Drug: CYP3A4, CYP2C8, and CYP2C9 substrates, and hormonal contraceptive |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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)
Key exclusion criteria (30 listed)
- 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).
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 |
|---|---|---|
| PralsetinibPralsetinib 400mg orally (PO) once daily (QD) from Day 4 to Day 10, with an option to continue up to Day 33 | Drug | Pralsetinib with CYP450 Probe Substrates and Hormonal Contraceptive |
| CYP3A4, CYP2C8, and CYP2C9 substrates, and hormonal contraceptiveMidazolam, repaglinide, and losartan (CYP probe substrates) and, for female participants, estradiol/norethisterone acetate (hormonal probe substrate), administered orally (PO) once on Day 1 and once on Day 9. | Drug | Pralsetinib with CYP450 Probe Substrates and Hormonal Contraceptive |
Primary outcome
Area Under the Plasma Concentration-Time Curve from zero to infinity (AUC0-inf)
Time frame: Up to 48 hours post-dose or as appropriate for each probe substrate
To evaluate the effect of pralsetinib on the overall exposure of CYP3A4, CYP2C8, and CYP2C9, probe substrates, and hormonal contraceptive by measuring AUC0-inf for each probe substrate and its relevant metabolites.
Area under the plasma concentration-time curve from time zero to time of last measurable concentration (AUClast)
Time frame: Up to 48 hours after each probe drug administration
To evaluate the effect of pralsetinib on the overall exposure of CYP3A4, CYP2C8, and CYP2C9 probe substrates, and hormonal contraceptive by measuring AUClast for each probe substrate and its relevant metabolites.
Maximum Peak Plasma Concentration (Cmax)
Time frame: Up to 48 hours after each probe drug administration
To evaluate how pralsetinib affects the peak levels of probe substrates, and hormonal contraceptive, in the blood after they are taken alone and again after treatment with pralsetinib
8 secondary outcomes
Time to Maximum Plasma Concentration (tmax)
Time frame: Up to 48 hours after each probe drug administration
Terminal Half-Life (t½)
Time frame: Up to 48 hours after each probe drug administration
Percent of Area Under the plasma concentration-time curve obtained at extrapolation (%AUCex)
Time frame: Up to 48 hours after each probe drug administration
Mean residence time (MRT)
Time frame: Up to 48 hours after each probe drug administration
Terminal Elimination Rate Constant (λz)
Time frame: Up to 48 hours after each probe drug administration
Apparent Total Body Clearance (CL/F)
Time frame: Up to 48 hours after each probe drug administration
Apparent Volume of Distribution (Vz/F)
Time frame: Up to 48 hours after each probe drug administration
Safety and Tolerability
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 10 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 Pralsetinib and CYP3A4, CYP2C8, and CYP2C9 substrates, and hormonal contraceptive in people with NSCLC (Non-small Cell Lung Cancer) and Thyroid Cancer, run by Rigel Pharmaceuticals at 2 sites in Spain.
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 19 inclusion and 30 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 10 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 Spain. 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 from zero to infinity (AUC0-inf) (time frame: Up to 48 hours post-dose or as appropriate for each probe substrate). The study lists 3 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 10 Aug 2026.