A Study of an IDH1m Inhibitor in Participants With IDH1-Mutated Malignancies and Hepatic or Renal Impairment

Active:	Yes
Cancer Type:	Solid Tumor	NCT ID:	NCT07006688
Trial Phases:	Phase I	Protocol IDs:	S095031-218 (primary) NCI-2025-07166 2024-517923-38-00
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Servier Bio-Innovation LLC
NCI Full Details:	http://clinicaltrials.gov/show/NCT07006688

Summary

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.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

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