Ivosidenib in Participants With Locally Advanced or Metastatic Conventional Chondrosarcoma Untreated or Previously Treated With 1 Systemic Treatment Regimen (CHONQUER)

February 4, 2026 updated by: Servier Bio-Innovation LLC

A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled Study of Ivosidenib in Participants ≥18 Years of Age With Locally Advanced or Metastatic Conventional Chondrosarcoma With an IDH1 Mutation, Untreated or Previously Treated With 1 Systemic Treatment Regimen

Study CL3-95031-007 (CHONQUER) is a Phase 3, international, multicenter, double-blind, randomized, placebo-controlled study of orally administered ivosidenib. Participants are required to have a histopathological diagnosis consistent with isocitrate dehydrogenase-1 (IDH1) gene-mutated, locally advanced or metastatic conventional chondrosarcoma Grades 1, 2, or 3 and not eligible for curative resection. IDH1 mutant status will be determined during pre-screening/screening phase. Participant must have radiographic progression/recurrence of disease according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1) and have received 0 to 1 prior systemic treatment regimen in the advanced/metastatic setting for conventional chondrosarcoma. The primary endpoint is progression-free survival (PFS) in Grades 1 and 2 participants. Key secondary endpoints are PFS in all randomized participants, overall survival (OS) in Grades 1 and 2 participants, and OS in all randomized participants.

Participants who meet enrollment criteria will be randomized 1:1 to receive oral ivosidenib 500mg once daily, or a matching placebo once daily.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

136

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Institut de Recherches Internationales Servier (I.R.I.S.), Clinical Studies Department
  • Phone Number: +33 1 55 72 60 00
  • Email: scientificinformation@servier.com

Study Locations

  • Australia
      • Bedford Park, Australia, 5042
        • Recruiting
        • Flinders Medical Centre
        • Contact:
        • Principal Investigator:
          • Ganessan Kichenadasse, MD
        • Contact:
          • Phone Number: 61882044997
      • Camperdown, Australia, 2050
        • Recruiting
        • Chris O'Brien Lifehouse
      • Camperdown, Australia, 2050
        • Not yet recruiting
        • Chris O'Brien Lifehouse
        • Contact:
      • Fitzroy, Australia, 3065
        • Recruiting
        • St Vincent's Hospital Melbourne
        • Contact:
      • Nedlands, Australia, 6009
        • Recruiting
        • Sir Charles Gairdner Hospital
      • Woolloongabba, Australia, 4102
  • Belgium
      • Brussels, Belgium, 1200
        • Recruiting
        • Cliniques Universitaires St. Luc
      • Ghent, Belgium, 9000
        • Recruiting
        • U.Z. Gent
      • Liège, Belgium, 4000
        • Recruiting
        • Centre Multidisciplinaire de Oncologie Medicale
  • Brazil
      • Barretos, Brazil, 14784-400
        • Recruiting
        • Hospital de Amor - Barretos
      • Belo Horizonte, Brazil, 30130-100
        • Recruiting
        • Hospital das Clinicas da UFMG
      • Curitiba, Brazil, 80810-050
        • Recruiting
        • CIONC
      • Florianópolis, Brazil, 88034-000
        • Recruiting
        • CEPON - Centro de Pesquisas Oncologicas
      • Jaú, Brazil, 17210-080
        • Recruiting
        • Fundação Amaral Carvalho - Jaú/ Sp
      • Rio de Janeiro, Brazil, 20220-410
        • Recruiting
        • Instituto Nacional Do Câncer - Inca
      • São Paulo, Brazil, 01246-000
        • Recruiting
        • ICESP - Instituto do Cancer do Estado de Sao Paulo
      • São Paulo, Brazil, 01509-010
        • Recruiting
        • Hospital A C Camargo
      • São Paulo, Brazil, 05652-900
        • Recruiting
        • Hospital Albert Einstein
      • São Paulo, Brazil, 01409-902
        • Recruiting
        • Impar Serviços Hospitalares S.A. - Hospital Nove de Julho
    • Rio Grande do Norte
      • Natal, Rio Grande do Norte, Brazil, 59062-000
        • Recruiting
        • Liga Norte Riograndense Contra O Cancer
  • Canada
    • Alberta
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Recruiting
        • University Health Network
        • Contact:
          • Phone Number: 5553 4165964200
        • Principal Investigator:
          • ABDULAZEEZ SALAWU, MD
    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
  • China
      • Beijing, China, 100142
        • Recruiting
        • Beijing Cancer Hospital
      • Beijing, China, 102208
        • Recruiting
        • Beijing Jishuitan Hospital
      • Guangzhou, China, 450003
        • Recruiting
        • Henan Cancer Hospital
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Recruiting
        • The First Affiliated Hospital of Sun Yat-sen University
    • Hubei
      • Wuhan, Hubei, China, 430023
        • Recruiting
        • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
    • Shanghai Municipality
      • Shang'ai, Shanghai Municipality, China, 200000
        • Recruiting
        • Shanghai Changzheng Hospital
      • Shanghai, Shanghai Municipality, China, 200025
        • Recruiting
        • Shanghai Ruijin Hospital
      • Shanghai, Shanghai Municipality, China, 200080
        • Recruiting
        • Shanghai General Hospital
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Recruiting
        • West China Hopital of Sichuan University
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310025
        • Recruiting
        • The Second Affiliated Hospital Zhejiang University School of Medical
  • Denmark
      • Aarhus, Denmark, 8200
        • Recruiting
        • Aarhus Universitetshospital
      • Herlev, Denmark, 2730
        • Recruiting
        • Herlev & Gentofte Hospital
  • France
      • Bordeaux, France, 33076
        • Recruiting
        • Institut Bergonie
      • Lille, France, 59020
        • Recruiting
        • Centre Oscar Lambret
      • Lyon, France, 69008
        • Recruiting
        • Hôpital Léon Berard
      • Marseille, France, 13005
        • Recruiting
        • Hôpital de la Timone
      • Paris, France, 75014
        • Recruiting
        • Hopital Cochin
      • Saint-Herblain, France, 44805
        • Recruiting
        • Institut de Cancerologie de L'Ouest
      • Toulouse, France, 31059
        • Recruiting
        • IUCT-Oncopole Institut Universitaire du Cancer
      • Villejuif, France, 94800
        • Recruiting
        • Institut Gustave Roussy
  • Germany
      • Bad Saarow, Germany, 15526
      • Berlin, Germany, 13353
        • Recruiting
        • Charite Universitatsmedizin
      • Dresden, Germany, 01307
        • Recruiting
        • Universitätsklinikum Carl Gustav Carus Dresden
        • Contact:
          • Uniklinik Dresden Studiensekretariat Onkologie
          • Phone Number: +49351-4587683
          • Email: oncostudy@ukdd.de
      • Hamburg, Germany, 20246
        • Recruiting
        • Universitätsklinikum Hamburg-Eppendorf
      • Mannheim, Germany, 68167
        • Recruiting
        • Universitätsmedizin Mannheim (UMM)
      • München, Germany, 81377
        • Recruiting
        • LMU Klinikum
      • Münster, Germany, 48149
      • Ulm, Germany, 89081
        • Recruiting
        • Universitaetsklinikum Ulm
  • Italy
      • Bologna, Italy, 40136
        • Recruiting
        • IRCCS Istituto Ortopedico Rizzoli
      • Milan, Italy, 20133
        • Recruiting
        • Irccs Fondazione Istituto Nazionale Dei Tumori
      • Orbassano, Italy, 10043
        • Recruiting
        • San Luigi Gonzaga University Hospital of Turin
        • Contact:
      • Padua, Italy, 35128
        • Recruiting
        • Istituto Oncologico Veneto IOV - IRCCS
      • Palermo, Italy, 90127
        • Recruiting
        • AOU Policlinico Paolo Giaccone
      • Prato, Italy, 59100
      • Roma, Italy, 00128
        • Recruiting
        • Policlinico Universitario Campus Biomedico
        • Contact:
      • Roma, Italy, 00144
        • Recruiting
        • Istituti Fisioterapici Ospitalieri (Ifo) - Istituto Nazionale Tumori Regina Elena (Ire)
  • Japan
      • Chuo-ku, Tokyo, Japan, 104-0045
        • Recruiting
        • National Cancer Center Hospital
      • Fukushima, Japan, 960-1295
        • Recruiting
        • Fukushima Medical University Hospital
      • Higashi, Japan, 812-8582
        • Recruiting
        • Kyushu University Hospital
      • Koto-Ku, Tokyo, Japan, 135-8550
        • Recruiting
        • Cancer Institute Hospital of JFCR
        • Contact:
          • Phone Number: 0335200111
        • Principal Investigator:
          • KENJI NAKANO, MD
      • Okayama, Japan, 700-8558
        • Recruiting
        • Okayama University Hospital
        • Contact:
        • Principal Investigator:
          • Tomohiro Fujiwara, MD
        • Sub-Investigator:
          • Toshifumi Ozaki, MD
        • Sub-Investigator:
          • Eiji Nakata, MD
        • Sub-Investigator:
          • Kiichiro Ninomiya, MD
        • Sub-Investigator:
          • Ayako Morita, MD
        • Sub-Investigator:
          • Go Makimoto, MD
        • Sub-Investigator:
          • Eiki Ichihara, MD
        • Sub-Investigator:
          • Kotaro Yamada, MD
        • Sub-Investigator:
          • Miho Fujiwara, MD
        • Sub-Investigator:
          • Takahiro Baba, MD
        • Sub-Investigator:
          • Kammei Rai, MD
        • Sub-Investigator:
          • Masahiro Tabata, MD
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 003-0804
        • Recruiting
        • Hokkaido Cancer Center
    • Ishikawa-ken
      • Kanazawa, Ishikawa-ken, Japan, 920-8641
        • Recruiting
        • Kanazawa University Hospital
        • Contact:
        • Principal Investigator:
          • AKIHIRO NISHIYAMA, MD
    • Nagoya-shi, Aichi
      • Shōwaku, Nagoya-shi, Aichi, Japan, 466-8560
        • Recruiting
        • Nagoya University Hospital
    • Niigata City
      • Chūōku, Niigata City, Japan, 951-8510
        • Recruiting
        • Niigata University Medical and Dental General Hospital
    • Oita Prefecture
      • Yufu-Shi, Oita Prefecture, Japan, 879-5593
        • Recruiting
        • Oita University Hospital
    • Osaka-shi, Osaka
      • Chūōku, Osaka-shi, Osaka, Japan, 700-8558
        • Recruiting
        • Osaka International Cancer Institute
  • Netherlands
      • Groningen, Netherlands, 9713 GZ
      • Leiden, Netherlands, 2333 ZA
        • Recruiting
        • Leids Universitair Medisch Centrum
        • Contact:
      • Nijmegen, Netherlands, 6525 GA
  • Puerto Rico
      • Rio Piedras, Puerto Rico, 00935
        • Recruiting
        • Pan American Center for Oncology Trials, LLC
  • South Korea
      • Seoul, South Korea, 05505
        • Recruiting
        • Asan Medical Center
      • Seoul, South Korea, 03080
        • Recruiting
        • Seoul National University Hospital
      • Seoul, South Korea, 06351
        • Recruiting
        • Samsung Medical Center
      • Seoul, South Korea, 03722
        • Recruiting
        • Severance Hospital
  • Spain
      • Barcelona, Spain, 08041
        • Recruiting
        • Hospital de la Santa Creu i Sant Pau
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitario Valle de Hebrón - Vhio
        • Contact:
      • L'Hospitalet de Llobregat, Spain, 08908
        • Recruiting
        • Hospital de Bellvitge - Ico
      • Madrid, Spain, 28046
        • Recruiting
        • Hospital Universitario La Paz
      • Madrid, Spain, 28040
        • Recruiting
        • Hospital Universitario Fundacion Jimenez Diaz
        • Contact:
          • Javier Martin Broto
        • Contact:
      • Madrid, Spain, 28007
        • Recruiting
        • Hospital General Universitario Gregorio
      • Valencia, Spain, 46026
        • Recruiting
        • Hospital Universitario y Politécnico La Fe
        • Contact:
  • Taiwan
      • Taipei, Taiwan, 100225
        • Recruiting
        • National Taiwan University Hospital
        • Contact:
      • Taipei, Taiwan, 112201
        • Recruiting
        • Taipei Veterans General Hospital
        • Contact:
  • United Kingdom
      • Edinburgh, United Kingdom
        • Recruiting
        • Western General Hospital
      • London, United Kingdom
        • Recruiting
        • Royal Marsden Hospital
      • London, United Kingdom
      • Manchester, United Kingdom, M20 4BX
        • Recruiting
        • Christie Hospital
      • Oxford, United Kingdom
        • Recruiting
        • Churchill Hospital
  • United States
    • California
      • Los Angeles, California, United States, 90033
        • Recruiting
        • Usc Norris Comprehensive Cancer Center
      • Santa Monica, California, United States, 90403
        • Recruiting
        • Sarcoma Oncology Research Center
        • Contact:
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University Of Colorado Cancer Center
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • Recruiting
        • Yale Cancer Center
        • Contact:
    • Florida
      • Jacksonville, Florida, United States, 32224
      • Miami, Florida, United States, 33136-1002
        • Recruiting
        • University of Miami
    • Georgia
      • Atlanta, Georgia, United States, 30308
    • Illinois
      • Chicago, Illinois, United States, 60611-5975
        • Recruiting
        • Robert H. Lurie Comprehensive Cancer Center of Northwestern University
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • University of Iowa Hospitals & Clinics- Holden Comprehensive Cancer Center
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • Johns Hopkins University
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Dana-Farber Cancer Institute
        • Contact:
          • DFCI Sarcoma Center
          • Phone Number: 617-632-5204
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic - Rochester, Mn
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • The Washington University
    • Nebraska
      • Omaha, Nebraska, United States, 68118
        • Recruiting
        • Nebraska Methodist Hospital
    • New York
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
        • Principal Investigator:
          • William Tap, MD
        • Contact:
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke University
        • Contact:
    • Ohio
      • Cleveland, Ohio, United States, 44195
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • The Ohio State University Comprehensive Cancer Center
        • Contact:
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health & Science University Knight Cancer Institute
        • Contact:
          • OHSU Clinical Trials Office
          • Phone Number: 503-494-1080
          • Email: trials@ohsu.edu
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15232
        • Recruiting
        • University of Pittsburgh Medical Center-Hillman Cancer Center
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt University Medical Center
        • Contact:
          • Clinical Research Coordinator
          • Phone Number: 800-811-8480
          • Email: cip@vumc.org
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • The Univeristy of Texas Md Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Have a histopathological diagnosis (fresh or banked tumor biopsy sample collected within the last 3 years) consistent with locally advanced or metastatic conventional chondrosarcoma Grades 1, 2, or 3 and not eligible for curative resection.
  • Have at least one BICR-confirmed measurable lesion as defined by RECIST v1.1. Participants who have received prior radiation therapy are eligible provided measurable disease falls outside of the treatment field or within the field and has shown ≥20% growth in size since post-treatment assessment.
  • Have received 0 or 1 prior systemic treatment regimen in the advanced/metastatic setting for chondrosarcoma.

  • Have radiographic progression/recurrence of disease according to RECIST v1.1 defined as:

    1. Radiographic progression of disease (local and/or distant) documented by 2 imaging assessments performed no more than 6 months (±2 weeks) apart within 12 months before randomization.

      OR

    2. Any recurrence of disease (local and/or distant) after complete surgical resection and documented by imaging within 6 months (±2 weeks) before randomization.
  • Have documented IDH1 gene-mutated disease (from a fresh tumor biopsy or the most recent banked tumor tissue available that was sourced from either a primary or metastatic tumor lesion) based on central laboratory testing (R132C/L/G/H/S mutation variants tested)
  • Have recovered from any clinically relevant sequelae and toxic effects of any prior surgery, radiotherapy, or other therapy intended for the treatment of cancer.

Exclusion Criteria:

  • Are unable to swallow oral medication.
  • Pregnant or lactating women.
  • Are participating in another interventional study at the same time; participation in noninterventional registries or epidemiological studies is allowed.
  • Have received prior therapy with an IDH1 inhibitor
  • Have received systemic anticancer therapy <2 weeks prior to randomization (for investigational or immune-based anticancer therapy <4 weeks).
  • Have received radiotherapy <2 weeks prior to randomization.
  • Have known symptomatic brain metastases requiring steroids >10 mg per day prednisone (or equivalent). Participants with previously diagnosed brain metastases are eligible if they have completed their treatment and have recovered from the acute effects of radiation therapy or surgery prior to randomization, have discontinued or reduced corticosteroid treatment <=10 mg per day for these metastases for at least 4 weeks and have radiographically stable disease of brain lesions for at least 3 months prior to randomization.
  • Have a history of another primary cancer, with the exception of: a) curatively resected non-melanoma skin cancer; b) curatively treated carcinoma in situ; or c) pT1-2 prostatic cancer Gleason score <6 or d) participant is free of other primary solid or liquid tumor for ≥ 1 year prior to the start of study treatment and, in the opinion of the Investigator, the disease will not affect participant's outcome in the setting of current chondrosarcoma diagnosis.
  • Have had major surgery within 4 weeks prior to randomization.
  • Have significant active cardiac disease within 6 months prior to randomization, including New York Heart Association (NYHA) Class III or IV congestive heart failure; myocardial infarction; unstable angina; and/or stroke.
  • Have LVEF <40% by ECHO scan (or by other methods according to institutional practice) obtained within 28 days prior to randomization.
  • Have a heart-rate corrected QT interval (using Fridericia's formula) (QTcF) ≥ 450 msec or other factors that increase the risk of QT prolongation or arrhythmic events (eg, heart failure, hypokalemia, family history of long QT interval syndrome). Participants with a bundle branch block combined with a prolonged QTcF interval may be permitted based on local cardiology assessment.
  • Have known medical history of progressive multifocal leukoencephalopathy (PML).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ivosidenib
Taken continuously until BICR-confirmed disease progression, unacceptable toxicity, confirmed pregnancy, death, withdrawal of consent, lost to follow-up, or the Sponsor ends the study (estimated average treatment duration of two years).
Drug: Ivosidenib 500mg
Provided as tablets, taken orally as two 250mg tablets once daily.
Placebo Comparator: Placebo
Taken continuously until BICR-confirmed disease progression, unacceptable toxicity, confirmed pregnancy, death, withdrawal of consent, lost to follow-up, or the Sponsor ends the study (estimated average treatment duration of two years). Participants randomized to the placebo arm who experience BICR-confirmed disease progression and meet the crossover eligibility criteria will be given the opportunity to cross over and receive ivosidenib.
Drug: Placebo
Provided as tablets, taken orally once daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival (PFS) based on Blinded Independent Central Reviewer (BICR) assessment in Grade 1 and Grade 2 participants
Time Frame: Up to approximately 31 months
From randomization until BICR confirmed progressive disease or death due to any cause, whichever occurs first
Up to approximately 31 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS based on BICR assessment in all randomized participants
Time Frame: Up to approximately 31 months
From randomization until BICR confirmed progressive disease or death due to any cause, whichever occurs first
Up to approximately 31 months
Overall survival (OS) in Grade 1 and Grade 2 participants
Time Frame: Up to 5 years
From randomization until death
Up to 5 years
OS in all randomized participants
Time Frame: Up to 5 years
From randomization until death
Up to 5 years
PFS based on Investigator assessment in Grade 1 and Grade 2 participants
Time Frame: Up to approximately 31 months
From randomization until BICR confirmed progressive disease or death due to any cause, whichever occurs first
Up to approximately 31 months
PFS based on Investigator assessment in all randomized participants
Time Frame: Up to approximately 31 months
From randomization until BICR confirmed progressive disease or death due to any cause, whichever occurs first
Up to approximately 31 months
Objective response (OR) (confirmed complete response(CR) or confirmed partial response (PR)) of anti-tumor activity (using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1) in Grade 1 and Grade 2 participants
Time Frame: Up to approximately 31 months
From randomization until confirmed CR or PR
Up to approximately 31 months
OR (confirmed CR or confirmed PR) of anti-tumor activity (using RECIST v1.1) in all randomized participants
Time Frame: Up to approximately 31 months
From randomization until confirmed CR or PR
Up to approximately 31 months
Duration of response (DOR) in Grade 1 and Grade 2 participants
Time Frame: Up to approximately 31 months
The time from date of first documented confirmed CR or confirmed PR to date of first documented disease progression or death due to any cause.
Up to approximately 31 months
DOR in all randomized participants
Time Frame: Up to approximately 31 months
The time from date of first documented confirmed CR or confirmed PR to date of first documented disease progression or death due to any cause.
Up to approximately 31 months
Time to response (TTR) in Grade 1 and Grade 2 participants
Time Frame: Up to approximately 31 months
The time from the date of randomization to date of first documented confirmed complete response (CR) or confirmed partial response (PR).
Up to approximately 31 months
TTR in all randomized participants
Time Frame: Up to approximately 31 months
The time from the date of randomization to date of first documented confirmed complete response (CR) or confirmed partial response (PR).
Up to approximately 31 months
Disease control (DC) confirmed CR, confirmed PR, or stable disease (SD)) in Grade 1 and Grade 2 participants
Time Frame: Through the end of the study (a maximum of 5 years after the study start)
Through the end of the study (a maximum of 5 years after the study start)
DC (confirmed CR, confirmed PR, or SD) in all randomized participants
Time Frame: Through the end of the study (a maximum of 5 years after the study start)
Through the end of the study (a maximum of 5 years after the study start)
Duration of disease control (DoDC) in Grade 1 and Grade 2 participants
Time Frame: Through the end of the study (a maximum of 5 years after the study start)
Through the end of the study (a maximum of 5 years after the study start)
DoDC in all randomized participants
Time Frame: Through the end of the study (a maximum of 5 years after the study start)
Through the end of the study (a maximum of 5 years after the study start)
Number of Adverse Events (AEs)
Time Frame: Through the Safety Follow-up Visit (28-33 days after discontinuation of treatment)
Through the Safety Follow-up Visit (28-33 days after discontinuation of treatment)
Number of Serious Adverse Events (SAEs)
Time Frame: Through the Safety Follow-up Visit (28-33 days after discontinuation of treatment)
Through the Safety Follow-up Visit (28-33 days after discontinuation of treatment)
Number of Adverse Events of Special Interest (AESIs)
Time Frame: Through the Safety Follow-up Visit (28-33 days after discontinuation of treatment)
Through the Safety Follow-up Visit (28-33 days after discontinuation of treatment)
Number of Adverse Events (AEs) leading to discontinuation, treatment interruption, and dose reduction
Time Frame: Through the Safety Follow-up Visit (28-33 days after discontinuation of treatment)
Through the Safety Follow-up Visit (28-33 days after discontinuation of treatment)
European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) score
Time Frame: Through the Safety Follow-up Visit (28-33 days after discontinuation of treatment)
The EORTC-QLQ-C30 contains 30 items across 5 functional scales, 9 symptom scales and a global health status. Raw scores are converted to scales ranging from 0 - 100. For the functional scales and global health status, the higher score represents the better functioning or global health status; for the symptom scales, the higher score represents an increase in symptoms.
Through the Safety Follow-up Visit (28-33 days after discontinuation of treatment)
European Quality of Life 5 Dimensions 5 Level (EQ-5D-5L) score
Time Frame: Through the Safety Follow-up Visit (28-33 days after discontinuation of treatment)
The 5-level EQ-5D-5L scores range from 5 to 25 with a higher number representing a worse health status.
Through the Safety Follow-up Visit (28-33 days after discontinuation of treatment)
Patient-Reported Outcomes Measurement Information System (PROMIS) score
Time Frame: Through the Safety Follow-up Visit (28-33 days after discontinuation of treatment)
The PROMIS Item Bank v1.0 Physical Function with Mobility Aid - Short Form questionnaire score ranges from 1 "Unable to do" to 5 "Can do without a problem" for each capability.
Through the Safety Follow-up Visit (28-33 days after discontinuation of treatment)
Ivosidenib concentration in plasma
Time Frame: Through the end of the study (a maximum of 5 years after the study start)
Through the end of the study (a maximum of 5 years after the study start)
2-hydroxyglutarate (2-HG) concentration in plasma
Time Frame: Through the end of the study (a maximum of 5 years after the study start)
Through the end of the study (a maximum of 5 years after the study start)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Servier Bio-Innovation LLC

Collaborators

Institut de Recherches Internationales Servier

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 9, 2024

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

November 26, 2030

Study Registration Dates

First Submitted

November 7, 2023

First Submitted That Met QC Criteria

November 7, 2023

First Posted (Actual)

November 13, 2023

Study Record Updates

Last Update Posted (Actual)

February 6, 2026

Last Update Submitted That Met QC Criteria

February 4, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CL3-95031-007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data.

Access can be requested for all interventional clinical studies:

  • used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).
  • where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope.

In addition, access can be requested for all interventional clinical studies in patients:

  • sponsored by Servier
  • with a first patient enrolled as of 1 January 2004 onwards
  • for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.

IPD Sharing Time Frame

After Marketing Authorization in EEA or US if the study is used for the approval.

IPD Sharing Access Criteria

Researchers should register on Servier Data Portal and fill in the research proposal form. This form in four parts should be fully documented. The Research Proposal Form will not be reviewed until all mandatory fields are completed.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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