Trial Title:
Ivosidenib in Participants With Locally Advanced or Metastatic Conventional Chondrosarcoma Untreated or Previously Treated With 1 Systemic Treatment Regimen
NCT ID:
NCT06127407
Condition:
Locally Advanced or Metastatic Conventional Chondrosarcoma With an IDH1 Mutation, Untreated or Previously Treated With 1 Systemic Treatment Regimen
Conditions: Official terms:
Chondrosarcoma
Ivosidenib
Conditions: Keywords:
Conventional chondrosarcoma
IDH1
ivosidenib
locally advanced
metastatic
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Triple (Participant, Care Provider, Investigator)
Intervention:
Intervention type:
Drug
Intervention name:
Ivosidenib 500mg
Description:
Provided as tablets, taken orally as two 250mg tablets once daily.
Arm group label:
Ivosidenib
Intervention type:
Drug
Intervention name:
Placebo
Description:
Provided as tablets, taken orally once daily.
Arm group label:
Placebo
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.
Criteria for eligibility:
Criteria:
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).
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Usc Norris Comprehensive Cancer Center
Address:
City:
Los Angeles
Zip:
90033
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Sarcoma Oncology Research Center
Address:
City:
Santa Monica
Zip:
90403
Country:
United States
Status:
Recruiting
Facility:
Name:
Mayo Clinic - Jacksonville, Fl
Address:
City:
Jacksonville
Zip:
32224
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Miami
Address:
City:
Miami
Zip:
33136-1002
Country:
United States
Status:
Recruiting
Facility:
Name:
Robert H. Lurie Comprehensive Cancer Center of Northwestern University
Address:
City:
Chicago
Zip:
60611-5975
Country:
United States
Status:
Recruiting
Facility:
Name:
Dana-Farber Cancer Institute
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Recruiting
Facility:
Name:
Mayo Clinic - Rochester, Mn
Address:
City:
Rochester
Zip:
55905
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
The Washington University
Address:
City:
Saint Louis
Zip:
63110
Country:
United States
Status:
Recruiting
Facility:
Name:
Nebraska Methodist Hospital
Address:
City:
Omaha
Zip:
68118
Country:
United States
Status:
Recruiting
Facility:
Name:
Memorial Sloan Kettering Cancer Center
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Facility:
Name:
Usc Norris Comprehensive Cancer Center
Address:
City:
Durham
Zip:
27710
Country:
United States
Status:
Recruiting
Facility:
Name:
Cleveland Clinic
Address:
City:
Cleveland
Zip:
44195
Country:
United States
Status:
Recruiting
Facility:
Name:
The Ohio State University Comprehensive Cancer Center
Address:
City:
Columbus
Zip:
43210
Country:
United States
Status:
Recruiting
Facility:
Name:
Oregon Health & Science University Knight Cancer Institute
Address:
City:
Portland
Zip:
97239
Country:
United States
Status:
Recruiting
Facility:
Name:
The Univeristy of Texas Md Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Facility:
Name:
Flinders Medical Centre
Address:
City:
Bedford Park
Zip:
5042
Country:
Australia
Status:
Recruiting
Contact:
Last name:
GANESSAN KICHENADASSE
Phone:
61882048997
Email:
ganessan.kichenadasse@sa.gov.au
Facility:
Name:
Princess Alexandra Hospital
Address:
City:
Woolloongabba
Zip:
4102
Country:
Australia
Status:
Recruiting
Facility:
Name:
Hospital de Amor - Barretos
Address:
City:
Barretos
Zip:
14784-400
Country:
Brazil
Status:
Recruiting
Facility:
Name:
CIONC
Address:
City:
Curitiba
Zip:
80810-050
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Cepon - Centro de Pesquisas Oncologicas
Address:
City:
Florianópolis
Zip:
88034-000
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Fundação Amaral Carvalho - Jaú/ Sp
Address:
City:
Jaú
Zip:
17210-080
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Instituto Nacional Do Câncer - Inca
Address:
City:
Rio De Janeiro
Zip:
20220-410
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Icesp - Instituto Do Câncer Do Estado de São Paulo
Address:
City:
São Paulo
Zip:
01246-000
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Hospital A C Camargo
Address:
City:
São Paulo
Zip:
01509-010
Country:
Brazil
Status:
Recruiting
Facility:
Name:
UNIVERSITY HEALTH NETWORK, Princess Margaret Cancer Centre,
Address:
City:
Toronto
Zip:
M5G 2M9
Country:
Canada
Status:
Recruiting
Contact:
Last name:
ABDULAZEEZ SALAWU
Phone:
4165964200
Phone ext:
X-5553
Email:
abdulazeez.salawu@uhn.ca
Facility:
Name:
Muhc Glen Site
Address:
City:
Montréal
Zip:
H4A 3J1
Country:
Canada
Status:
Recruiting
Facility:
Name:
Hokkaido Cancer Center
Address:
City:
Sapporo
Zip:
003-0804
Country:
Japan
Status:
Recruiting
Facility:
Name:
Kanazawa University Hospital
Address:
City:
Kanazawa
Zip:
920-8641
Country:
Japan
Status:
Recruiting
Facility:
Name:
Nagoya University Hospital
Address:
City:
Showa-ku
Zip:
466-8560
Country:
Japan
Status:
Recruiting
Facility:
Name:
Osaka International Cancer Institute
Address:
City:
Chuo Ku
Zip:
700-8558
Country:
Japan
Status:
Recruiting
Facility:
Name:
Kyushu University Hospital
Address:
City:
Higashi
Zip:
812-8582
Country:
Japan
Status:
Recruiting
Facility:
Name:
Cancer Institute Hospital of Jfcr
Address:
City:
Tokyo
Zip:
135-8550
Country:
Japan
Status:
Recruiting
Facility:
Name:
Okayama University Hospital
Address:
City:
Yufu
Zip:
879-5503
Country:
Japan
Status:
Recruiting
Start date:
July 9, 2024
Completion date:
November 26, 2030
Lead sponsor:
Agency:
Servier Bio-Innovation LLC
Agency class:
Industry
Collaborator:
Agency:
Institut de Recherches Internationales Servier
Agency class:
Other
Source:
Servier
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06127407
