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Cerca in Study Connect

Recruiting

A Phase 1 Study to Evaluate the Potential Drug Interactions Between Repotrectinib and Metformin, Digoxin, and Rosuvastatin in Patients With Advanced Solid Tumors - CA127-1027

Aggiornato: 9 aprile, 2024   |   ClinicalTrials.gov.

Stampi il riassunto semplice

STA PRENDENDO IN CONSIDERAZIONE QUESTA SPERIMENTAZIONE?
Stampi questa pagina e la guida alla sperimentazione da utilizzare come supporto nel colloquio con il Suo medico.
Utilizzi la Guida per i partecipanti allo studio per esplorare il processo di partecipazione a una sperimentazione clinica. Comprenda i fattori chiave da considerare prima di decidere e pensi alle domande da porre al Suo team di professionisti sanitari.

Dettagli della sperimentazione

  • Phase 1

    Fase

  • Sesso

  • 18+

    Fascia d'età

  • 1

    Sede/i

  • Recruiting

Opzioni di trattamento

Bracci dello studio
INTERVENTO ASSEGNATO
Experimental: Repotrectinib (TPX-0005)
Drug: TPX-0005, Rosuvastatin Calcium, Digoxin, Metformin Hydrochloride

Principali criteri di idoneità

Key Inclusion Criteria: 1. Histologically or cytologically confirmed diagnosis of locally advanced, or metastatic solid tumor (including primary central nervous system [CNS] tumors) that harbors a ROS1 or NTRK1-3 gene fusion. 2. Patient must have a documented ROS1 or NTRK1-3 gene fusion determined by tissue-based local testing. 3. Patients must have an Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2 (≥ 18 years). 4. Protocol specified baseline hematology, liver function and kidney function laboratory values. Key Exclusion Criteria: 1. Concurrent participation in another therapeutic clinical trial. 2. Symptomatic brain metastases or leptomeningeal involvement. 3. Major surgery within 4 weeks of start of repotrectinib treatment. 4. Clinically significant cardiovascular disease. 5. History of non-pharmacologically induced prolonged QTc interval 6. Known active infections requiring ongoing treatment (bacterial, fungal, viral including human immunodeficiency virus positivity). 7. Gastrointestinal disease or other malabsorption syndromes. 8. Current or anticipated use of drugs that are known to be moderate or strong CYP3A inhibitors or inducers. 9. Patients who have received, or are expected to receive metformin, digoxin or rosuvastatin within 14 days prior to beginning of the DDI assessment period. 10. Patients who have received or are expected to receive drugs that are inhibitors of P-gp, OATP1B1, BCRP, and MATE2-K within 14 days or 5 half-lives (whichever is longer) prior to beginning of the DDI assessment period until the DDI assessment period is completed.

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Segnala effetti collaterali (eventi avversi) o reclami sulla qualità del prodotto: informazioni mediche