Study of ivosidenib in adults with advanced or metastatic chondrosarcoma with IDH1 mutation who are untreated or have had one prior treatment

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What is this study about?

This study focuses on conventional chondrosarcoma, a type of bone cancer that has spread locally or to other parts of the body (locally advanced or metastatic) and contains a specific genetic change called an IDH1 mutation. The study will test a medication called ivosidenib (also known as AG-120/S95031), which is given as film-coated tablets taken by mouth.

The purpose of this research is to determine how well ivosidenib works in treating patients with Grade 1 and Grade 2 chondrosarcoma. The study will compare ivosidenib to a placebo in patients who have either not received any previous systemic treatment or have had one prior treatment for their cancer. Participants will be randomly assigned to receive either ivosidenib tablets or matching placebo tablets.

During the study, participants will take the study medication daily. The treatment may continue for up to 24 months. Throughout the study, doctors will monitor the participants’ health and perform regular assessments to check how their cancer responds to the treatment. The study will measure how long participants live without their cancer getting worse, along with other factors such as overall survival and quality of life.

1 Initial treatment assignment

You will be randomly assigned to receive either ivosidenib tablets or placebo tablets. The study is double-blind, which means neither you nor the doctor will know which treatment you are receiving.

The medication will be in the form of film-coated tablets for oral use.

2 Treatment period

You will take the assigned medication orally according to the prescribed schedule.

Regular imaging scans will be performed to monitor your condition and assess how the tumor responds to treatment.

Your doctor will monitor your health status through various tests and examinations.

3 Health assessments

Your tumor will be evaluated using imaging scans to measure any changes in size.

You will complete several questionnaires about your quality of life and health status, including:

– Quality of life assessment (EORTC QLQ-C30)

– Health status evaluation (EQ-5D-5L)

– Additional health-related questions (PROMIS)

Blood samples will be collected to measure drug and 2-HG levels in your plasma.

4 Safety monitoring

Your doctor will monitor and record any side effects or health changes throughout the study.

Regular check-ups will be conducted to ensure your safety during the trial.

The study team will track any adverse events that may occur during treatment.

5 Study duration

The study is expected to run from May 2024 to April 2031.

Your individual participation duration will be determined by how your condition responds to the treatment.

Who Can Join the Study?

You must have a confirmed diagnosis of conventional chondrosarcoma (a type of bone tumor) that is either locally advanced or has spread to other parts of the body (metastatic), with grades 1, 2, or 3, diagnosed within the last 3 years
Your tumor must have a specific genetic change called an IDH1 mutation (R132C/L/G/H/S variants), which must be confirmed by laboratory testing
You must have at least one measurable tumor that can be assessed by imaging scans
Your disease must show progression, demonstrated by either:
- Growth of tumor shown on two imaging scans taken no more than 6 months apart within the last year
- Return of disease within 6 months after complete surgical removal
For Grade 1 and 2 tumors, you should have received either no previous systemic treatment (like chemotherapy) or only one previous treatment. For Grade 3 tumors, up to two previous treatments are allowed
Your tumor must not be suitable for complete surgical removal or other local treatments like radiation therapy
If you had previous treatments (surgery, radiation, or other cancer therapies), you must have recovered from their side effects
If you previously received radiation therapy, your measurable tumor must either be outside the treated area or show at least 20% growth in the treated area after radiation

Who Cannot Join the Study?

Age under 18 years old
Presence of any brain metastases (cancer that has spread to the brain) that are not fully treated
Previous treatment with more than 1 systemic therapy (medications that travel through the bloodstream)
Pregnant or breastfeeding women
Severe heart problems, including:
- Uncontrolled high blood pressure
- Recent heart attack
- Unstable heart rhythm disorders
Severe liver problems or abnormal liver function tests
Severe kidney problems or abnormal kidney function tests
Active, uncontrolled infections
Other types of cancer within the past 3 years (except for adequately treated non-melanoma skin cancer or cervical cancer in situ)
Any medical condition that, in the opinion of the study doctor, would make it unsafe to participate in the trial
Unable to swallow oral medications
Known allergic reactions to similar medications

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Institut Gustave Roussy	Villejuif	France
Oncopole Claudius Regaud	Toulouse	France
Technische Universitaet Dresden	Dresden	Germany
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Universitaetsklinikum Heidelberg AöR	Heidelberg	Germany
Comite Entreprise Paul Papin	Angers	France

Other Sites

Site Name	City	Country
Istituto Oncologico Veneto	Padua	Italy
Azienda Ospedaliero-Universitaria San Luigi Gonzaga	Orbassano	Italy
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Azienda USL Toscana Centro	Prato	Italy
Istituto Ortopedico Rizzoli	Bologna	Italy
Centre hospitalier universitaire de Liege	Liege	Belgium
HELIOS Klinikum Bad Saarow GmbH	Bad Saarow	Germany
Universitair Ziekenhuis Gent	Gent	Belgium
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone	Palermo	Italy
Universita’ Campus Bio-medico Di Roma	Rome	Italy
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Stichting Radboud University Medical Center	Nijmegen	The Netherlands
Region Midtjylland	Aarhus	Denmark
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH	Ulm	Germany
Hopital Beaujon	Clichy	France
Clandioqu Uznilniikkzhuu Skanqcnld	Woluwe-Saint-Lambert	Belgium
Hnbvlb Hzljwmce	Herlev	Denmark
Abketzisre Pnyghbhn Hjikjkhp Ds Maaotcvuc	Marseille	France
Kbdomvvi dkc Utqfbearqkjv Mgtuxzik Abj	Munich	Germany
Hnupgdtm Dh Lh Szcyv Ccfq I Snlo Pht	Barcelona	Spain
Cadaev Lxav Besibw	Lyon	France
Uwmlojvzqp Mvowcfb Cpfrit Hcqsrbywkowwujlku	Hamburg	Germany
Iztxaa Isxhrstr Fjslbjjkhdxwm Odektxlvusm	Rome	Italy
Lxxky Uckecorrpycz Mprjfbm Ciarurk (ajsbc	Leiden	The Netherlands
Utvwazfwknel Mxsunff Cqhsmmv Gwejvsikm	Groningen	The Netherlands
Iiuwougu Cmasrq Drwvxzswpqbviqxhr	L'hospitalet De Llobregat	Spain
Fgtfpstax Pfub Lt Ikvmedgrpobjl Bjanmyhpb Dzi Hgzlpzsf Ukavdyfyjdfsg Ly Pxk	Madrid	Spain
Utzuaikhosfdokewatoel Mnkmyguv Aty	Munster	Germany
Hsifubmn Vpot dhwtuswl	Barcelona	Spain
Cecvss Olgdw Ldfqsdh	Lille	France
Hjgrgain Uhybbbdtyaahku Shklsbsjov &hstbnl Hqnotlp db Hfnzfpiludi	STRASBOURG, Alsace	France

Trial status

Country	Status	Recruitment Start
Belgium	Recruiting	06.05.2024
Denmark	Recruiting	06.05.2024
France	Recruiting	06.05.2024
Germany	Recruiting	06.05.2024
Italy	Recruiting	06.05.2024
Spain	Recruiting	06.05.2024
The Netherlands	Recruiting	06.05.2024

Trial locations

Investigated drugs:

Ivosidenib

Ivosidenib is a medication used to treat certain types of cancer, specifically chondrosarcoma with an IDH1 mutation. It works by blocking a specific enzyme that is altered in cancer cells. This medication is designed to help patients who have locally advanced or metastatic conventional chondrosarcoma, either as their first treatment or after they have already received one previous treatment. It is taken orally and targets the specific genetic mutation (IDH1) found in the tumor cells.

Chondrosarcoma – A rare type of bone cancer that develops in cartilage cells. This cancer typically starts in the bones of the arms, legs, or pelvis, though it can occur in any part of the body where cartilage is present. The disease begins when cartilage cells start growing abnormally, forming tumors that can grow into and destroy healthy bone tissue. Conventional chondrosarcoma is the most common form of this cancer, and it can be classified into different grades based on how the cells look under a microscope. When described as locally advanced, it means the cancer has grown into nearby tissues, while metastatic indicates it has spread to other parts of the body. Some cases of chondrosarcoma have a specific mutation in the IDH1 gene, which affects how cells process energy.

Trial ID:

2023-508507-20-00

Protocol code:

CL3-95031-007

NCT ID:

NCT06127407

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of ivosidenib in adults with advanced or metastatic chondrosarcoma with IDH1 mutation who are untreated or have had one prior treatment

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?