RecruitingPhase IEN original

Pharmacokinetics and Safety Study of Pelabresib in Patients With Advanced Malignancies and Hepatic Impairment

⚠️

This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

The primary purpose of this study is to evaluate the impact of hepatic function on the pharmacokinetic (PK) profile of pelabresib in participants with advanced malignancies who have either hepatic impairment (HI) or normal liver function. To reduce participant burden and maximize benefit, the PK of pelabresib will be assessed at steady-state rather than after a single dose, avoiding treatment-free washout periods.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • Wiek od 18 do 75 lat
  • Rozpoznany zaawansowany rak, dla którego nie ma standardowego leczenia
  • Wystarczająca liczba płytek krwi (≥150)
  • Wystarczająca liczba białych krwinek (≥1)
  • Prawidłowa funkcja nerek (klirens kreatyniny ≥30 mL/min)
  • Mniej niż 5% blastów w krwi
  • Spodziewana długość życia co najmniej 3 miesiące
  • Wyzdrowienie po dużej operacji i po wcześniejszej chemioterapii

✗ Disqualifies

  • Uczulenie na lek pelabresib lub podobne leki
  • Ciąża potwierdzona testem lub karmienie piersią
  • Inne warunki medyczne, które mogą być niebezpieczne w badaniu

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Maximum age
75 Years
Last updated (source)
July 8, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (8)

Novartis Investigative Site

Bordeaux, France

Novartis Investigative Site

Saint-Herblain, France

Novartis Investigative Site

Candiolo, Italy

Novartis Investigative Site

Pozuelo de Alarcón, Spain

Novartis Investigative Site

Barcelona, Spain

Novartis Investigative Site

Madrid, Spain

Novartis Investigative Site

Madrid, Spain

Novartis Investigative Site

London, United Kingdom

Trial contact

Novartis Pharmaceuticals

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/9/2026.

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