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NCT07006688 · ClinicalTrials.gov registry record · Phase 1
A Study of an IDH1m Inhibitor in Participants With IDH1-Mutated Malignancies and Hepatic or Renal Impairment
A Phase 1 study of IDH1-Mutated Malignancies, sponsored by Servier Bio-Innovation.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 18
- Study locations
NCT07006688 is a Phase 1 study of IDH1-Mutated Malignancies that is actively recruiting participants, run by Servier Bio-Innovation. The registered enrollment target is 30 participants. The trial reports 18 study locations across 8 states.
The verdict
NCT07006688, a Phase 1 study of IDH1-Mutated Malignancies, is actively recruiting participants, sponsored by Servier Bio-Innovation.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 18
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG Ivosidenib Oral Tablet
Study Locations (18)
Other
- Instituto do Cancer do Estado de Sao Paulo - São Paulo
- University Hospital Brno - Brno
- Fakultni nemocnice Ostrava - Ostrava
- Vseobecna fakultni nemocnice v Praze - Prague
- Seoul National University Hospital - Seoul
- Severence Hospital, Yonsei University Health Systems - Seoul
- Asan Medical Center - Seoul
- START - Hospital HM Nou Delfos - Barcelona
- START Madrid - Fundacion Jimenez Diaz - Madrid
- Hospital Universitario 12 de Octubre - Madrid
- START Madrid Centro Oncologico Clara Campal Sanchinarro Univesrity Hospital - Madrid
Georgia
- Emory University - Atlanta
Texas
- MD Anderson - Houston
Queensland
- Icon Cancer Centre - South Brisbane
South Australia
- Royal Adelaide Hospital - Adelaide
São Paulo
- Hospital de Base de Sao Jose do Rio Preto - São José do Rio Preto
HlavnÃ- Mesto Praha
- Fakultni nemocnice v Motole FN Motol - Prague
Gyeonggi-do
- Seoul National University Bundang Hospital - Seongnam-si
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2026-01-14 |
| Est. Completion | 2028-08-31 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07006688
The ClinicalTrials.gov registry entry for NCT07006688 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Servier Bio-Innovation, which has 9 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with IDH1-Mutated Malignancies appearing as the primary indexed condition, and to 1 intervention - of which Ivosidenib Oral Tablet is the first listed.
NCT07006688 reports 18 study locations spanning 8 distinct geographic areas - top geographies include Other, Georgia, Texas.
Frequently Asked Questions
What is clinical trial NCT07006688 about?
NCT07006688 is a clinical study titled "A Study of an IDH1m Inhibitor in Participants With IDH1-Mutated Malignancies and Hepatic or Renal Impairment". 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. Durin...
What is the current status of trial NCT07006688?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2026-01-14. Estimated completion is 2028-08-31.
What conditions does trial NCT07006688 study?
This clinical trial studies the following conditions: IDH1-Mutated Malignancies.
What interventions are being tested in trial NCT07006688?
The interventions under investigation include: Ivosidenib Oral Tablet (DRUG).
Who is sponsoring clinical trial NCT07006688?
This trial is sponsored by Servier Bio-Innovation, which has 9 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07006688 being conducted?
This trial has 18 study locations across Georgia, Texas, Queensland, South Australia, São Paulo. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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