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

Status: Recruiting
Location: See all (107) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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:

‣ 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

⁃ 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.

Locations
United States
California
Usc Norris Comprehensive Cancer Center
RECRUITING
Los Angeles
Sarcoma Oncology Research Center
RECRUITING
Santa Monica
Colorado
University of Colorado Cancer Center
RECRUITING
Aurora
Connecticut
Yale Cancer Center
RECRUITING
New Haven
Florida
Mayo Clinic - Jacksonville, Fl
RECRUITING
Jacksonville
University of Miami
RECRUITING
Miami
Georgia
Emory Winship Cancer Institute
RECRUITING
Atlanta
Iowa
University of Iowa Hospitals & Clinics- Holden Comprehensive Cancer Center
RECRUITING
Iowa City
Illinois
Robert H. Lurie Comprehensive Cancer Center of Northwestern University
RECRUITING
Chicago
Massachusetts
Dana-Farber Cancer Institute
RECRUITING
Boston
Minnesota
Mayo Clinic - Rochester, Mn
RECRUITING
Rochester
Missouri
The Washington University
RECRUITING
St Louis
North Carolina
Duke University
RECRUITING
Durham
Nebraska
Nebraska Methodist Hospital
RECRUITING
Omaha
New York
Memorial Sloan Kettering Cancer Center
RECRUITING
New York
Ohio
Cleveland Clinic
RECRUITING
Cleveland
The Ohio State University Comprehensive Cancer Center
RECRUITING
Columbus
Oregon
Oregon Health & Science University Knight Cancer Institute
RECRUITING
Portland
Pennsylvania
University of Pittsburgh Medical Center-Hillman Cancer Center
RECRUITING
Pittsburgh
Tennessee
Vanderbilt University Medical Center
RECRUITING
Nashville
Texas
The Univeristy of Texas Md Anderson Cancer Center
RECRUITING
Houston
Other Locations
Australia
Flinders Medical Centre
RECRUITING
Bedford Park
Chris O'Brien Lifehouse
NOT_YET_RECRUITING
Camperdown
Chris O'Brien Lifehouse
RECRUITING
Camperdown
St Vincent'S Hospital Melbourne
RECRUITING
Fitzroy
Sir Charles Gairdner Hospital
RECRUITING
Nedlands
Princess Alexandra Hospital
RECRUITING
Woolloongabba
Belgium
Cliniques Universitaires St. Luc
RECRUITING
Brussels
Brazil
Hospital de Amor - Barretos
RECRUITING
Barretos
Hospital Das Clínicas Da Ufmg
RECRUITING
Belo Horizonte
CIONC
RECRUITING
Curitiba
Cepon - Centro de Pesquisas Oncologicas
RECRUITING
Florianópolis
Fundação Amaral Carvalho - Jaú/ Sp
RECRUITING
Jaú
Liga Norte Riograndense Contra O Cancer
RECRUITING
Natal
Instituto Nacional Do Câncer - Inca
RECRUITING
Rio De Janeiro
Hospital A C Camargo
RECRUITING
São Paulo
Hospital Albert Einstein
RECRUITING
São Paulo
Icesp - Instituto Do Câncer Do Estado de São Paulo
RECRUITING
São Paulo
Impar Serviços Hospitalares S.A. - Hospital Nove de Julho
RECRUITING
São Paulo
Canada
Muhc Glen Site
RECRUITING
Montreal
Alberta Health Services
RECRUITING
Toronto
University Health Network
RECRUITING
Toronto
China
Beijing Cancer Hospital
RECRUITING
Beijing
Beijing Jishuitan Hospital
RECRUITING
Beijing
West China Hopital of Sichuan University
RECRUITING
Chengdu
Henan Cancer Hospital
RECRUITING
Guangzhou
The First Affiliated Hospital of Sun Yat-Sen University
RECRUITING
Guangzhou
The Second Affiliated Hospital Zhejiang University School of Medical
RECRUITING
Hangzhou
Shanghai Changzheng Hospital
RECRUITING
Shang'ai
Shanghai General Hospital
RECRUITING
Shanghai
Shanghai Ruijin Hospital
RECRUITING
Shanghai
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
RECRUITING
Wuhan
Denmark
Aarhus Universitetshospital
RECRUITING
Aarhus
France
Institut Bergonié
RECRUITING
Bordeaux
Centre Oscar Lambret
RECRUITING
Lille
Hôpital Léon Bérard
RECRUITING
Lyon
Hopital de La Timone
RECRUITING
Marseille
Hôpital Cochin
RECRUITING
Paris
INSTITUT de CANCEROLOGIE de l'Ouest
RECRUITING
Saint-herblain
Iuct-Oncopole Institut Universitaire Du Cancer
RECRUITING
Toulouse
Institut Gustave Roussy
RECRUITING
Villejuif
Germany
Helios Klinikum Bad Saarow
RECRUITING
Bad Saarow
Charite Universitatsmedizin
RECRUITING
Berlin
Universitätsklinikum Carl Gustav Carus Dresden
RECRUITING
Dresden
Universitatsklinikum Hamburg-Eppendorf
RECRUITING
Hamburg
Universitätsmedizin Mannheim (Umm)
NOT_YET_RECRUITING
Mannheim
Lmu Klinikum
NOT_YET_RECRUITING
München
Ukm - Sarkom-Zentrum
RECRUITING
Münster
Universitaetsklinikum Ulm
RECRUITING
Ulm
Italy
Irccs Istituto Ortopedico Rizzoli
RECRUITING
Bologna
Irccs Fondazione Istituto Nazionale Dei Tumori
RECRUITING
Milan
San Luigi Gonzaga University Hospital of Turin
RECRUITING
Orbassano
Istituto Oncologico Veneto Iov - Irccs
RECRUITING
Padua
Aou Policlinico Paolo Giaccone
RECRUITING
Palermo
Ospedale Santo Stefano
RECRUITING
Prato
Istituti Fisioterapici Ospitalieri (Ifo) - Istituto Nazionale Tumori Regina Elena (Ire)
RECRUITING
Roma
Policlinico Universitario Campus Biomedico
RECRUITING
Roma
Japan
National Cancer Center Hospital
RECRUITING
Chuo-ku, Tokyo
Niigata University Medical and Dental General Hospital
RECRUITING
Chūōku
Osaka International Cancer Institute
RECRUITING
Chūōku
Kyushu University Hospital
RECRUITING
Higashi
Kanazawa University Hospital
RECRUITING
Kanazawa
Cancer Institute Hospital of Jfcr
RECRUITING
Koto-ku, Tokyo
Okayama University Hospital
RECRUITING
Okayama
Hokkaido Cancer Center
RECRUITING
Sapporo
Nagoya University Hospital
RECRUITING
Shōwaku
Oita University Hospital
RECRUITING
Yufu-shi
Netherlands
Universitair Medisch Centrum Groningen (Umcg)
RECRUITING
Groningen
Leids Universitair Medisch Centrum
RECRUITING
Leiden
Radboud Umc
RECRUITING
Nijmegen
Republic of Korea
Asan Medical Center
RECRUITING
Seoul
Samsung Medical Center
RECRUITING
Seoul
Seoul National University Hospital
RECRUITING
Seoul
Severance Hospital
RECRUITING
Seoul
Spain
Hospital de La Santa Creu I Sant Pau
RECRUITING
Barcelona
Hospital Universitario Valle de Hebrón - Vhio
RECRUITING
Barcelona
Hospital de Bellvitge - Ico
RECRUITING
L'hospitalet De Llobregat
Hospital General Universitario Gregorio
RECRUITING
Madrid
Hospital Universitario Fundación Jiménez Díaz
RECRUITING
Madrid
Hospital Universitario La Paz
RECRUITING
Madrid
Hospital Universitario Y Politecnico La Fe
RECRUITING
Valencia
Taiwan
National Taiwan University Hospital
RECRUITING
Taipei
United Kingdom
Western General Hospital
RECRUITING
Edinburgh
Royal Marsden Hospital
RECRUITING
London
UCLH
RECRUITING
London
Christie Hospital
RECRUITING
Manchester
Churchill Hospital
RECRUITING
Oxford
Contact Information
Primary
Institut de Recherches Internationales Servier (I.R.I.S.), Clinical Studies Department
scientificinformation@servier.com
+33 1 55 72 60 00
Time Frame
Start Date: 2024-07-09
Estimated Completion Date: 2030-11-26
Participants
Target number of participants: 136
Treatments
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).
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.
Sponsors
Leads: Servier Bio-Innovation LLC
Collaborators: Institut de Recherches Internationales Servier

This content was sourced from clinicaltrials.gov

Similar Clinical Trials