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COMPLETEDPHASE2

Efficacy and Safety of Imatinib in Chordoma

Phase II Study of Imatinib Mesylate in Chordoma

NCT00150072•Novartis Pharmaceuticals

Summary

Preliminary response data, observed by Casali (Cancer, 2004) with imatinib 800 mg/day in patients affected by chordoma, need to be confirmed by a Phase II study, whose primary endpoint will be the formal assessment of clinical and pathological response. Aim of the study will be to explore treatment's activity, but also the potential impact of tumor response, the feasibility and outcome of subsequent surgery and radiotherapy. In addition, patterns of tumour response need to be investigated as well, given the peculiar patterns of response shown with molecular-targeted therapy in solid tumors.

Eligibility

Age

All ages

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Histological diagnosis of chordoma.
•2. Biomolecular or immunohistochemical evidence of Imatinib mesylate target (PDGFRβ activation and/or presence of PDGFB). Biomolecular assessment of PDGFRβ activation should be made whenever possible. To this end, if frozen material is not available, obtaining of, fresh material is encouraged, if it should be obtained with no major distress for the patient, preferably through an incisional biopsy (to allow immunoprecipitation) or, if this is not feasible, a Trucut biopsy (to allow Western Blot assessment). However, if frozen or fresh material cannot be obtained, paraffined material is also acceptable.
•The biomolecular assessment will be centralized to the reference centers (to be defined).
•3. Measurable or evaluable disease
•4. Surgical resection of local disease unfeasible radically, or unaccepted by the patient, or amenable to become less demolitive, or easier, or likely more feasible, after cytoreduction, and/or metastatic disease. Debulking surgery before enrolment is allowed. In this case, enrolment should occur at least one month after surgery
•5. Performance status 0, 1, 2 or 3 (ECOG) (see § 8.1).
•6. Adequate end organ function, defined as the following: total bilirubin \<1.5 x ULN, SGOT and SGPT \<2.5 x UNL (or \<5 x ULN if hepatic metastases are present), creatinine \<1.5 x ULN.
•7. Adequate bone marrow function, defined as the following: ANC \>1.5 x 10\^9/L, platelets \>100 x 10\^9/L, Hb \>9 g/dL. Blood transfusions are allowed to reach the baseline requested Hb level.
•8. Female patients of child-bearing potential must have negative pregnancy test within 7 days before initiation of study drug dosing. Post menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Male and female patients of reproductive potential must agree to employ an effective method of birth control throughout the study and for up to 3 months following discontinuation of study drug.
•9. Written, voluntary, informed consent.

Exclusion Criteria

•1. Previous treatment with any other investigational or not investigational agents within 28 days of first day of study drug dosing.
•2. Other primary malignancy with \<5 years clinically assessed disease-free interval, except basal cell skin cancer, cervical carcinoma in situ, or other neoplasms judged to entail a low risk of relapse.
•3. Grade III/IV cardiac problems as defined by the New York Heart Association Criteria (i.e., congestive heart failure, myocardial infarction within 6 months of study)
•4. Severe and/or uncontrolled medical disease (i.e., uncontrolled diabetes, chronic renal disease, or active uncontrolled infection).
•5. Known brain metastasis.
•6. Known chronic liver disease (i.e., chronic active hepatitis, and cirrhosis).
•7. Known diagnosis of human immunodeficiency virus (HIV) infection.
•8. Previous radiotherapy to \>=25 % of the bone marrow.
•9. Major surgery within 2 weeks prior to study entry.
•10. Expected non-compliance to medical regimens.

Locations (12)

Novartis Investigative Site

Aviano, Italy

Novartis Investigative Site

Bologna, Italy

Novartis Investigative Site

Candiolo, Italy

Novartis Investigative Site

Florence, Italy

Novartis Investigative Site

Milan, Italy

Novartis Investigative Site

Naples, Italy

Novartis Investigative Site

Padua, Italy

Novartis Investigative Site

Pisa, Italy

Novartis Investigative Site

Roma, Italy

Novartis Investigative Site

Rozzano, Italy

Key Dates

Start Date

October 1, 2004

Primary Completion Date

April 1, 2008

Completion Date

April 1, 2008

Last Updated

February 23, 2017

Enrollment

ACTUAL participants

Conditions

Chordoma

Interventions

imatinib

DRUG

A Study of ERAS-601 in People With Chordoma

NCT06957327

Chordoma

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RECRUITINGPHASE1/PHASE2

Tazemetostat+Nivo/Ipi in INI1-Neg/SMARCA4-Def Tumors

NCT05407441

Atypical Teratoid Rhabdoid TumorINI1 (SMARCB1)-Deficient Primary CNS Malignant Tumors+5 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 23, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Efficacy and Safety of Imatinib in Chordoma

Inclusion Criteria

Exclusion Criteria

A Study of ERAS-601 in People With Chordoma

Tazemetostat+Nivo/Ipi in INI1-Neg/SMARCA4-Def Tumors

Proton Radiation for Chordomas and Chondrosarcomas

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