Actively Recruiting
A Study of an IDH1m Inhibitor in Participants With IDH1-Mutated Malignancies and Hepatic or Renal Impairment
Led by Servier Bio-Innovation LLC · Updated on 2026-05-12
30
Participants Needed
19
Research Sites
137 weeks
Total Duration
On this page
Sponsors
S
Servier Bio-Innovation LLC
Lead Sponsor
I
Institut de Recherches Internationales Servier
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of an IDH1m Inhibitor in Participants With IDH1-Mutated Malignancies and Hepatic or Renal Impairment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults with hematologic malignancies or solid tumors (excluding glioma) confirmed to have IDH1 R132 mutation
- Participants grouped by liver or kidney function: moderate hepatic impairment with total bilirubin >1.5 to 3 times upper limit of normal (ULN), severe hepatic impairment with total bilirubin >3 times ULN, severe renal impairment with creatinine clearance 15 to 29 mL/min, or control groups with normal/mild impairment
- Adequate kidney function for hepatic impairment groups (creatinine clearance ≥60 mL/min)
- Adequate liver function for severe renal impairment group (total bilirubin ≤1.5 times ULN unless Gilbert's disease, AST and other enzymes ≤3 times ULN)
- Participants previously or currently treated with ivosidenib at specified doses are eligible
- Women of childbearing potential must agree to use two effective forms of birth control during the study and for 90 days after last dose
You will not qualify if you...
- Stem cell transplant within 60 days or active graft-versus-host disease requiring systemic therapy
- Recent anticancer therapy, investigational treatment, radiotherapy within 14 days, or surgery within 4 weeks before starting ivosidenib
- Other hematologic diseases or solid tumors with available beneficial treatments
- Use of calcineurin inhibitors within 4 weeks prior to enrollment
- Significant active heart disease within 6 months before starting treatment
- Use of medications that prolong QT interval without appropriate management
- Planned use of strong CYP3A4 inducers or sensitive CYP3A4 substrates during study participation
- Active inflammatory gastrointestinal diseases or conditions limiting oral drug absorption
- Known family history of sudden death or certain heart rhythm disorders
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 19 locations
1
Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
2
MD Anderson
Houston, Texas, United States, 77030
Not Yet Recruiting
3
Icon Cancer Centre
South Brisbane, Queensland, Australia, 4101
Actively Recruiting
4
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Actively Recruiting
5
Hospital de Base de Sao Jose do Rio Preto
São José do Rio Preto, São Paulo, Brazil, 15090-000
Actively Recruiting
6
Instituto do Cancer do Estado de Sao Paulo
São Paulo, Brazil, 01246-000
Actively Recruiting
7
Fakultni nemocnice v Motole FN Motol
Prague, HlavnÃ- Mesto Praha, Czechia, 15000
Actively Recruiting
8
University Hospital Brno
Brno, Czechia, 62500
Withdrawn
9
Fakultni nemocnice Ostrava
Ostrava, Czechia, 70800
Actively Recruiting
10
Vseobecna fakultni nemocnice v Praze
Prague, Czechia, 128 00
Not Yet Recruiting
11
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea, 13620
Actively Recruiting
12
Seoul National University Hospital
Seoul, South Korea, 3080
Actively Recruiting
13
Severence Hospital, Yonsei University Health Systems
Seoul, South Korea, 3722
Actively Recruiting
14
Asan Medical Center
Seoul, South Korea, 5505
Actively Recruiting
15
START - Hospital HM Nou Delfos
Barcelona, Spain, 8023
Actively Recruiting
16
Hospital Universitari Vall d'Hebron
Barcelona, Spain, 8035
Not Yet Recruiting
17
START Madrid - Fundacion Jimenez Diaz
Madrid, Spain, 28040
Actively Recruiting
18
Hospital Universitario 12 de Octubre
Madrid, Spain, 28050
Actively Recruiting
19
START Madrid Centro Oncologico Clara Campal Sanchinarro Univesrity Hospital
Madrid, Spain, 28050
Actively Recruiting
Research Team
I
Institut de Recherches Internationales Servier (I.R.I.S.), Clinical Studies Department
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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