A Randomized, Open Label, Multi-center Phase III Study to... | EligiMed

A Randomized, Open Label, Multi-center Phase III Study to Evaluate the Efficacy and Safety of Nilotinib Versus Imatinib in Adult Patients With Unresectable or Metastatic Gastrointestinal Stromal Tumors (GIST)

CompletadoFase 3ClinicalTrials.gov

ID: NCT00785785Tipo: INTERVENTIONALInicio: 1 de mar de 2009Fin estimado: 1 de oct de 2014

Traducción no disponible, mostrando original

Resumen

This study will evaluate efficacy and safety of nilotinib versus imatinib in adult patients with unresectable or metastatic gastrointestinal stromal tumors (GIST).

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Histologically confirmed diagnosis of GIST which is unresectable and/or metastatic and either:
have not received any prior anti-neoplastic therapy other than adjuvant imatinib. Note: newly diagnosed patients may have received up to 14 days of treatment with imatinib for disease management while awaiting entry to the study or
recurrent GIST after stopping adjuvant treatment with imatinib and no subsequent treatment with any other therapies.
At least one measurable site of disease on CT/MRI scan
Performance status ≤ 2 (capable of self-care but unable to carry out any work)
Normal organ, electrolyte and marrow function

Criterios de exclusión

Any prior anti-neoplastic therapy with the exception of patients who have received adjuvant imatinib or patients with newly diagnosed metastatic/ unresectable GIST whose disease requires therapy while awaiting entry to the study.
Disease progression during adjuvant therapy with imatinib
History of active malignancy (other than GIST) within 10 years prior to study entry with the exception of previous or concomitant basal cell skin cancer, previous cervical carcinoma in situ.
Impaired cardiac function

Intervenciones

drug

Nilotinib (AMN107)

drug

imatinib (STI571)

Ubicaciones

Novartis Investigative Site

Buenos Aires, Buenos Aires, Argentina

Novartis Investigative Site

Caba, Buenos Aires, Argentina

Novartis Investigative Site

Rosario, Santa Fe Province, Argentina

Patrocinadores

PrincipalNovartis Pharmaceuticals

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