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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
500mg Ivosidenib taken orally once daily for continuous 28-day cycles
Emory University
Atlanta, Georgia, United States
RECRUITINGThe Ohio State University Wexner Medical Center, The James Cancer Hospital & Solove Research Institute
Columbus, Ohio, United States
NOT_YET_RECRUITINGMD Anderson
Houston, Texas, United States
RECRUITINGIcon Cancer Centre
South Brisbane, Queensland, Australia
RECRUITINGRoyal Adelaide Hospital
Adelaide, South Australia, Australia
RECRUITINGHospital de Base de Sao Jose do Rio Preto
São José do Rio Preto, São Paulo, Brazil
RECRUITINGInstituto do Cancer do Estado de Sao Paulo
São Paulo, Brazil
RECRUITINGFakultni nemocnice v Motole FN Motol
Prague, HlavnÃ- Mesto Praha, Czechia
RECRUITINGUniversity Hospital Brno
Brno, Czechia
WITHDRAWNFakultni nemocnice Ostrava
Ostrava, Czechia
RECRUITING...and 10 more locations
Maximum observed steady-state concentration (Cmax,ss)
Time frame: Through day 28 of cycle 1
Area under the concentration time curve from 0 to 24 hours (AUC0-24hr)
Time frame: Through day 28 of cycle 1
Predose plasma concentration (Ctrough)
Time frame: Through day 28 of cycle 1
Time to maximum observed concentration (Tmax)
Time frame: Through day 28 of cycle 1
Area under the effect concentration-time curve from time point 0 (predose) up to 8 hours postdose (AUEC0-8hr)
Time frame: Through day 28 of cycle 1
Percent inhibition for AUEC0-8hr (%BAUEC0-8hr)
Time frame: Through day 28 of cycle 1
Single dose ivosidenib plasma concentrations, maximum observed concentration (Cmax)
Time frame: Through day 28 of cycle 1
Single dose ivosidenib plasma concentrations AUC0-24hr
Time frame: Through day 28 of cycle 1
Single dose ivosidenib plasma concentrations Tmax
Time frame: Through day 28 of cycle 1
Steady-state unbound ivosidenib Cmax
Time frame: Day 28 of cycle 1
Steady-state unbound ivosidenib Ctrough
Time frame: Day 28 of cycle 1
Steady-state unbound ivosidenib AUC0-24hr
Time frame: Day 28 of cycle 1
Number of Adverse Events (AEs)
Time frame: Through the Safety Follow-up Visit, 30 days after last dose (approximately 3 years)
Number of Serious Adverse Events (SAEs)
Time frame: Through the Safety Follow-up Visit, 30 days after last dose (approximately 3 years)
Number of Adverse Events of Special Interest (AESIs)
Time frame: Through the Safety Follow-up Visit, 30 days after last dose (approximately 3 years)
Number of AEs leading to discontinuation
Time frame: Through the Safety Follow-up Visit, 30 days after last dose (approximately 3 years)
Institut de Recherches Internationales Servier (I.R.I.S.), Clinical Studies Department
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