Phase
Condition
Sarcoma (Pediatric)
Bone Neoplasm
Sarcoma
Treatment
Ivosidenib 500mg
Placebo
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Have a histopathological diagnosis (fresh or banked tumor biopsy sample collectedwithin the last 3 years) consistent with locally advanced or metastatic conventionalchondrosarcoma 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 providedmeasurable disease falls outside of the treatment field or within the field and hasshown ≥20% growth in size since post-treatment assessment.
Have received 0 or 1 prior systemic treatment regimen in the advanced/metastaticsetting for chondrosarcoma.
Have radiographic progression/recurrence of disease according to RECIST v1.1 definedas:
Radiographic progression of disease (local and/or distant) documented by 2imaging assessments performed no more than 6 months (±2 weeks) apart within 12months before randomization.OR
Any recurrence of disease (local and/or distant) after complete surgicalresection and documented by imaging within 6 months (±2 weeks) beforerandomization.
Have documented IDH1 gene-mutated disease (from a fresh tumor biopsy or the mostrecent banked tumor tissue available that was sourced from either a primary ormetastatic tumor lesion) based on central laboratory testing (R132C/L/G/H/S mutationvariants tested)
Have recovered from any clinically relevant sequelae and toxic effects of any priorsurgery, radiotherapy, or other therapy intended for the treatment of cancer.
Exclusion
Exclusion Criteria:
Are unable to swallow oral medication.
Pregnant or lactating women.
Are participating in another interventional study at the same time; participation innoninterventional registries or epidemiological studies is allowed.
Have received prior therapy with an IDH1 inhibitor
Have received systemic anticancer therapy <2 weeks prior to randomization (forinvestigational 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 areeligible if they have completed their treatment and have recovered from the acuteeffects of radiation therapy or surgery prior to randomization, have discontinued orreduced corticosteroid treatment <=10 mg per day for these metastases for at least 4weeks and have radiographically stable disease of brain lesions for at least 3months prior to randomization.
Have a history of another primary cancer, with the exception of: a) curativelyresected 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 primarysolid or liquid tumor for ≥ 1 year prior to the start of study treatment and, in theopinion of the Investigator, the disease will not affect participant's outcome inthe 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 heartfailure; myocardial infarction; unstable angina; and/or stroke.
Have LVEF <40% by ECHO scan (or by other methods according to institutionalpractice) obtained within 28 days prior to randomization.
Have a heart-rate corrected QT interval (using Fridericia's formula) (QTcF) ≥ 450msec 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 maybe permitted based on local cardiology assessment.
Have known medical history of progressive multifocal leukoencephalopathy (PML).
Study Design
Connect with a study center
Flinders Medical Centre
Bedford Park, 5042
AustraliaActive - Recruiting
Chris O'Brien Lifehouse
Camperdown, 2050
AustraliaSite Not Available
St Vincent'S Hospital Melbourne
Fitzroy, 3065
AustraliaActive - Recruiting
Sir Charles Gairdner Hospital
Nedlands, 6009
AustraliaActive - Recruiting
Princess Alexandra Hospital
Woolloongabba, 4102
AustraliaActive - Recruiting
Hospital de Amor - Barretos
Barretos, 14784-400
BrazilActive - Recruiting
Hospital Das Clínicas Da Ufmg
Belo Horizonte, 30130-100
BrazilActive - Recruiting
CIONC
Curitiba, 80810-050
BrazilActive - Recruiting
Cepon - Centro de Pesquisas Oncologicas
Florianópolis, 88034-000
BrazilActive - Recruiting
Fundação Amaral Carvalho - Jaú/ Sp
Jaú, 17210-080
BrazilActive - Recruiting
Instituto Nacional Do Câncer - Inca
Rio De Janeiro, 20220-410
BrazilActive - Recruiting
Hospital A C Camargo
São Paulo, 01509-010
BrazilActive - Recruiting
Hospital Albert Einstein
São Paulo, 05652-900
BrazilActive - Recruiting
Icesp - Instituto Do Câncer Do Estado de São Paulo
São Paulo, 01246-000
BrazilActive - Recruiting
UNIVERSITY HEALTH NETWORK, Princess Margaret Cancer Centre,
Toronto, Ontario M5G 2M9
CanadaActive - Recruiting
University Health Network
Toronto, Ontario M5G 2M9
CanadaActive - Recruiting
Muhc Glen Site
Montréal, Quebec H4A 3J1
CanadaActive - Recruiting
Hokkaido Cancer Center
Sapporo, Hokkaido 003-0804
JapanActive - Recruiting
Kanazawa University Hospital
Kanazawa, Ishikawa 920-8641
JapanActive - Recruiting
Nagoya University Hospital
Showa-ku, Nagoya-shi, Aichi 466-8560
JapanActive - Recruiting
Oita University Hospital
Yufu, Oita 879-5503
JapanActive - Recruiting
Osaka International Cancer Institute
Chuo Ku, Osaka-shi, Osaka 700-8558
JapanActive - Recruiting
National Cancer Center Hospital
Chuo-ku, Tokyo, 104-0045
JapanActive - Recruiting
Kyushu University Hospital
Higashi, 812-8582
JapanActive - Recruiting
Cancer Institute Hospital of Jfcr
Koto-Ku, Tokyo, 135-8550
JapanActive - Recruiting
Cancer Institute Hospital of Jfcr
Tokyo, 135-8550
JapanSite Not Available
Okayama University Hospital
Yufu, 879-5503
JapanActive - Recruiting
Okayama University Hospital
Yufu-shi, 879-5503
JapanActive - Recruiting
Oita University Hospital
Yufu-shi, Oita, 879-5503
JapanSite Not Available
Royal Marsden Hospital
London,
United KingdomActive - Recruiting
Christie Hospital
Manchester, M20 4BX
United KingdomActive - Recruiting
Usc Norris Comprehensive Cancer Center
Los Angeles, California 90033
United StatesActive - Recruiting
Sarcoma Oncology Research Center
Santa Monica, California 90403
United StatesActive - Recruiting
University of Colorado Cancer Center
Aurora, Colorado 80045
United StatesActive - Recruiting
Yale Cancer Center
New Haven, Connecticut 06511
United StatesActive - Recruiting
Mayo Clinic - Jacksonville, Fl
Jacksonville, Florida 32224
United StatesActive - Recruiting
University of Miami
Miami, Florida 33136-1002
United StatesActive - Recruiting
Emory Winship Cancer Institute
Atlanta, Georgia 30308
United StatesSite Not Available
Robert H. Lurie Comprehensive Cancer Center of Northwestern University
Chicago, Illinois 60611-5975
United StatesActive - Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts 02215
United StatesActive - Recruiting
Mayo Clinic - Rochester, Mn
Rochester, Minnesota 55905
United StatesActive - Recruiting
The Washington University
Saint Louis, Missouri 63110
United StatesActive - Recruiting
Nebraska Methodist Hospital
Omaha, Nebraska 68118
United StatesActive - Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United StatesActive - Recruiting
Duke University
Durham, North Carolina 27710
United StatesActive - Recruiting
Usc Norris Comprehensive Cancer Center
Durham, North Carolina 27710
United StatesActive - Recruiting
Cleveland Clinic
Cleveland, Ohio 44195
United StatesActive - Recruiting
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio 43210
United StatesActive - Recruiting
Oregon Health & Science University Knight Cancer Institute
Portland, Oregon 97239
United StatesActive - Recruiting
The Univeristy of Texas Md Anderson Cancer Center
Houston, Texas 77030
United StatesActive - Recruiting
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