A Study of an IDH1m Inhibitor in Participants With IDH1-Mutated Malignancies and Hepatic or Renal Impairment (NCT07006688)
A Phase 1, Multicenter, Open-Label, Safety and Pharmacokinetic Study of Orally Administered Ivosidenib in Participants With IDH1-Mutated Malignancies and Hepatic or Renal Impairment
🩺 Plain-English Summary (8th-Grade Level)
The objective of this study is to investigate the PK, PD, safety, and tolerability of ivosidenib in adult participants with IDH1-mutated malignancies and hepatic impairment (HI)/ renal impairment (RI). Participants will be enrolled into one of 5 groups based on their hepatic or renal function. During the treatment period participants will have study visits on days 1, 4, 8, 15, 22, and 28 of Cycle 1, on days 1 and 15 of Cycle 2 and 3, and on day 1 of each additional cycle. Each cycle is 28 consecutive days of treatment and cycles will be continuous until the end of the study. Approximately 30 days after treatment has ended, a safety follow-up visit will occur. Study visits may include blood tests, ECG, vital signs, and a physical examination.
Who can join: Review the eligibility criteria below.
Location: Emory University — Atlanta, Georgia
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (20 Sites)
- Emory University — Atlanta, Georgia
- The Ohio State University Wexner Medical Center, The James Cancer Hospital & Solove Research Institute — Columbus, Ohio
- MD Anderson — Houston, Texas
- Icon Cancer Centre — South Brisbane, Queensland
- Royal Adelaide Hospital — Adelaide, South Australia
- Hospital de Base de Sao Jose do Rio Preto — São José do Rio Preto, São Paulo
- Instituto do Cancer do Estado de Sao Paulo — São Paulo,
- Fakultni nemocnice v Motole FN Motol — Prague, HlavnÃ- Mesto Praha
- University Hospital Brno — Brno,
- Fakultni nemocnice Ostrava — Ostrava,
- Vseobecna fakultni nemocnice v Praze — Prague,
- Seoul National University Bundang Hospital — Seongnam-si, Gyeonggi-do
- Seoul National University Hospital — Seoul,
- Severence Hospital, Yonsei University Health Systems — Seoul,
- Asan Medical Center — Seoul,
- START - Hospital HM Nou Delfos — Barcelona,
- Hospital Universitari Vall d'Hebron — Barcelona,
- START Madrid - Fundacion Jimenez Diaz — Madrid,
- Hospital Universitario 12 de Octubre — Madrid,
- START Madrid Centro Oncologico Clara Campal Sanchinarro Univesrity Hospital — Madrid,
📞 Contact the Study Coordinator
Phone: +33 1 55 72 60 00
Email: scientificinformation@servier.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
Explore by condition: All IDH1-Mutated Malignancies clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.