Pralsetinib DDI Study 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

Trial Details

NCT ID
NCT07704658
Phase
PHASE4
Sponsor
Rigel Pharmaceuticals
Status
RECRUITING
Cancer Type
Lung Cancer
Interventions
  • Pralsetinib
  • CYP3A4, CYP2C8, and CYP2C9 substrates, and hormonal contraceptive
Locations (sample)
  • Logroño, La Rioja, Spain|42.46615,-2.45115
  • Madrid, Spain|40.4165,-3.70256

Key Eligibility 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.

For full eligibility, visit ClinicalTrials.gov.

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