Hemotrial Un proyecto de SEHH

Ensayo clínico

A Phase II Study to Determine the Activity of BMS-354825 in Subjects with ChronicPhase Philadelphia Chromosome-Positive Chronic Myeloid Leukemia Who HaveDisease that is Resistant to High Dose Imatinib Mesylate (Gleevec) or Who areIntolerant of Imatinib

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Resumen

2017-03-15 03:55:59
2004-002601-69
CA180-013
A Phase II Study to Determine the Activity of BMS-354825 in Subjects with ChronicPhase Philadelphia Chromosome-Positive Chronic Myeloid Leukemia Who HaveDisease that is Resistant to High Dose Imatinib Mesylate (Gleevec) or Who areIntolerant of Imatinib
CA180-013

PROMOTORES DEL ENSAYO
Nombre del promotor Organización Persona de contacto País
Bristol Myers Squibb International Corporation Belgium

Fármacos

  INFORMACIÓN DE FÁRMACOS USADOS:
  FÁRMACO 1:
Test
BMS-354825-03
BMS-354825-03 Tablet
Oral use

Detalles del Fármaco (Principio Activo):
BMS-354825-03

Concentración del fármaco:
mg milligram(s) equal

20

Contenido del fármaco

Si
No

No
Information no disponible en EudraCT

No
No

Information no disponible en EudraCT
Information no disponible en EudraCT

Information no disponible en EudraCT
No

No
No

No
  FÁRMACO 2:
Test
BMS-354825-03
BMS-354825-03 Tablet
Oral use

Detalles del Fármaco (Principio Activo):
BMS-354825-03

Concentración del fármaco:
mg milligram(s) equal

50

Contenido del fármaco

Si
No

No
Information no disponible en EudraCT

No
No

Information no disponible en EudraCT
Information no disponible en EudraCT

Information no disponible en EudraCT
No

No
No

No
  INFORMACIÓN DE PLACEBOS USADOS:

No hay placebos asignados al ensayo

Información General

Sindromes Mieloproliferativos

Chronic phase Philadelphia chromosome-positive chronic myeloid leukemia

The primary objective of this study is to estimate the major cytogenetic response (MCyR) rate to BMS-354825 in subjects with Philadelphia chromosome positive chronic phase Ph+ CML who have disease that is resistant to high dose imatinib (primary resistance, acquired resistance or mutation highly associated with imatinib resistance).

1) To estimate the MCyR rate in the imatinib-intolerant subjects.2) To assess the durability of MCyR and time to MCyR in the imatinib-resistant and the imatinib-intolerant groups3) To estimate complete hematologic response (CHR) rate, duration of CHR and time to CHR in the imatinib-resistant and the imatinib-intolerant groups4) To estimate major molecular response rate in the imatinib-resistant and the imatinib-intolerant groups5) To assess the health-related quality of life using the FACT-G6) To assess further the safety and tolerability of BMS-3548257) To collect blood samples for pharmacokinetic analysis of BMS-354825 given BIDthat will contribute to population pharmacokinetic modeling.

Information no disponible en EudraCT


1) Available for periodic follow-up2) Life expectancy of at least approximately 3 months3) ECOG performance status score 0-14) Subjects with chronic phase Ph+ CML, defined as a myeloproliferative disorder with evidence of a Philadelphia chromosome on cytogenetic analysis. Subjects meeting all of the following criteria will be classified as having chronic phase CML:• < 15% blasts in peripheral blood and in bone marrow• < 20% basophils in peripheral blood• < 30% blasts + promyelocytes in peripheral blood and in bone marrow• Platelets ? 100,000/mm3 unless thrombocytopenia is due to recent therapy• No extramedullary involvement (other than liver or spleen)5) Subjects must fulfill at least one of the following criteria relating to prior treatmentwith imatinib:A. Previously been treated with imatinib at a dose of > 600 mg/day AND developedprogressive disease while receiving imatinib at that dose. B. CML with resistance to imatinib ?600 mg/d with genetic mutation in the BCR-ABLgene that is associated with a high level of resistance to imatinib.C. Intolerant of imatinib at any dose.6) Adequate hepatic function defined as:• total bilirubin ? 2.0 times the institutional upper limit of normal• alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ?2.5 times the institutional upper limit of normal7) Adequate renal function defined as:• serum creatinine ? 1.5 times the institutional upper normal limit8) Serum potassium and magnesium levels within institutional normal limits. Totalserum calcium or ionized calcium level must be greater than or equal to the lowerlimit of normal.9) Men and women, ages 18 years of age or older.

1) Women who are pregnant or breastfeeding.2) WOCBP who are unwilling or unable to use an acceptable method to avoidpregnancy for the entire study period of at least 1 month before and at least 3 monthsafter completion of the study medication.3) Previous diagnosis of accelerated phase or blast crisis CML4) Subjects who are eligible and willing to undergo transplantation during the screening period5) A serious uncontrolled medical disorder or active infection that would impair theability of the subject to receive protocol therapy.6) Uncontrolled or significant cardiovascular disease7) History of significant bleeding disorder unrelated to CML,8) Concurrent incurable malignancy other than CML.9) Evidence of organ dysfunction or digestive dysfunction that would preventadministration of study therapy10) Subjects who receiveda) imatinib within 7 daysb) interferon or cytarabine within 14 daysc) a targeted small molecule anti-cancer agent within 14 days,d) any other investigational or antineoplastic agent other than hydroxyurea oranagrelide within 4 weeks before starting treatment with BMS-35482511) Subjects currently taking drugs that are generally accepted to have a risk of causing Torsade de Pointes.12) Subjects taking medications that irreversibly inhibit platelet function13) Subjects taking medications known to be potent CYP3A4 inhibitors or inducers14) Prior therapy with BMS-354825.

Efficacy:The primary endpoint of this Phase II study is to estimate MCyR rate to BMS-354825 in treated subjects with chronic phase Ph+ CML who have resistance to high dose imatinib (primary resistance, acquired resistance or mutation highly associated with imatinib resistance). Secondary endpoints include duration of MCyR, time to MCyR, complete hematologic response (CHR) rate, duration of CHR, time to CHR, major molecular response rate and BCR/ABL mutational analysis, in addition to health-related quality of life, safety and collection of samples to contribute to population pharmacokinetic modeling. A separate calculation of response rates will be performed for the imatinib-intolerant group at the time of the primary analysis for the imatinib-resistant subjects.Safety:Evaluation of safety will be a secondary endpoint of this study. For safety evaluation,toxic effects will be assessed continuously. All subjects who receive any study drug will be evaluable for toxicity. Adverse events and other symptoms will be graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0.The criteria for all the primary and secondary endpoints are defined in Protocol Section 3.3.

Fase II
  DISEÑO DEL ENSAYO:

No
No

No
No

No
No

No
No
  COMPARADOR DEL ENSAYO CONTROLADO:

No
No

No
No

Si

Centros participantes:

Si
Information no disponible en EudraCT
  TIEMPO ESTIMADO DURACIÓN DEL ENSAYO:

2
  TIEMPO ESTIMADO DURACIÓN DEL ENSAYO EN ESPAÑA:


  POBLACIÓN DE PACIENTES EN EL ESTUDIO:
  Población de pacientes: 1

Rango de edad:

0
1

1

Sexo:

1
1

Número planeado de pacientes a incluir:

Para estudios internacionales:

104
250

Investigadores

  INVESTIGADORES QUE PARTICIPAN EN EL ESTUDIO

Estado actual


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