Condition: IDH1-Mutated Malignancies · Sponsor: Servier Bio-Innovation LLC
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.
This description comes directly from the study's public registry record.
Institut de Recherches Internationales Servier (I.R.I.S.), Clinical Studies Department · +33 1 55 72 60 00 · scientificinformation@servier.com
Always discuss trial participation with your own doctor first.
| Emory University | Atlanta, Georgia, United States | Recruiting |
| MD Anderson | Houston, Texas, United States | Not Yet Recruiting |
| Icon Cancer Centre | South Brisbane, Queensland, Australia | Recruiting |
| Royal Adelaide Hospital | Adelaide, South Australia, Australia | Recruiting |
| Hospital de Base de Sao Jose do Rio Preto | São José do Rio Preto, São Paulo, Brazil | Recruiting |
| Instituto do Cancer do Estado de Sao Paulo | São Paulo, Brazil | Recruiting |
| Fakultni nemocnice v Motole FN Motol | Prague, HlavnÃ- Mesto Praha, Czechia | Recruiting |
| University Hospital Brno | Brno, Czechia | Withdrawn |
| Fakultni nemocnice Ostrava | Ostrava, Czechia | Recruiting |
| Vseobecna fakultni nemocnice v Praze | Prague, Czechia | Not Yet Recruiting |
| Seoul National University Bundang Hospital | Seongnam-si, Gyeonggi-do, South Korea | Recruiting |
| Seoul National University Hospital | Seoul, South Korea | Recruiting |
+ 7 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT07006688