OncoMatch/Clinical Trials/NCT07704658
Pralsetinib DDI Study in Patients With Advanced or Metastatic Solid Tumors
Is NCT07704658 recruiting? Yes, currently enrolling (Sep 2026). This Phase 4 trial studies multiple treatments including Pralsetinib and CYP3A4, CYP2C8, and CYP2C9 substrates, and hormonal contraceptive for nsclc (non-small cell lung cancer).
Treatment: Pralsetinib · CYP3A4, CYP2C8, and CYP2C9 substrates, and hormonal contraceptive — 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
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Other
Cancer type
Non-Small Cell Lung Carcinoma
Thyroid Gland Carcinoma
Tumor Agnostic
Biomarker criteria
Required: RET fusion or mutation
harbors an oncogenic RET fusion or mutation as determined by a validated test
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Lab requirements
Blood counts
ANC ≥ 1.0 × 10⁹/L; platelet count ≥ 75 × 10⁹/L; hemoglobin ≥ 9 g/dL
Kidney function
Creatinine clearance ≥ 40 mL/min using the Cockcroft-Gault equation
Liver function
AST and ALT ≤ 3 × ULN, or ≤ 5 × ULN in patients with known liver metastases; total bilirubin ≤ 1.5 × ULN (≤ 3 × ULN in patients with Gilbert syndrome)
Cardiac function
INR, PT, aPTT within normal laboratory limits; QTcF < 470 ms on at least 2 ECGs performed >30 minutes apart; no NYHA Class III/IV CHF, MI or unstable angina within 6 months, uncontrolled arrhythmias, uncontrolled hypertension or hypotension, history of prolonged QT syndrome or torsades de pointes
Must have adequate organ function, defined by the following: ANC ≥ 1.0 × 10⁹/L; platelet count ≥ 75 × 10⁹/L; hemoglobin ≥ 9 g/dL; AST and ALT ≤ 3 × 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; INR, PT, aPTT within normal laboratory limits; QTcF < 470 ms on at least 2 ECGs performed >30 minutes apart; no NYHA Class III/IV CHF, MI or unstable angina within 6 months, uncontrolled arrhythmias, uncontrolled hypertension or hypotension, history of prolonged QT syndrome or torsades de pointes
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07704658 currently recruiting?
Yes, this trial is currently recruiting patients.
Does this trial require RET?
Yes, RET fusion or mutation is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify