Hemotrial Un proyecto de SEHH

Ensayo clínico

A Randomized Multi-center Open Label Study of BMS-354825 vs.Imatinib Mesylate (Gleevec) 800 mg/d in Subjects with Chronic Phase PhiladelphiaChromosome-Positive Chronic Myeloid Leukemia Who Have Disease That is Resistantto Imatinib at a Dose at 400 - 600 mg/dProtocol version 3.0 dated 18-Nov-04, andCountry-specific Amendment 01 version 2.0 dated 28-Apr-05

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Resumen

2017-03-15 03:56:27
2004-004450-96
CA180-017
A Randomized Multi-center Open Label Study of BMS-354825 vs.Imatinib Mesylate (Gleevec) 800 mg/d in Subjects with Chronic Phase PhiladelphiaChromosome-Positive Chronic Myeloid Leukemia Who Have Disease That is Resistantto Imatinib at a Dose at 400 - 600 mg/dProtocol version 3.0 dated 18-Nov-04, andCountry-specific Amendment 01 version 2.0 dated 28-Apr-05
CA180-017

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 Gleevec
Novartis 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 Gleevec
Novartis 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
  FÁRMACO 3:
Comparator
Gleevec
Tablet
Oral use

Detalles del Fármaco (Principio Activo):

Concentración del fármaco:

mg milligram(s) equal

100

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 4:
Comparator
Gleevec
Tablet
Oral use

Detalles del Fármaco (Principio Activo):

Concentración del fármaco:

mg milligram(s) equal

400

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 (Ph+) Chronic Myeloid leukemia (CML)


The primary objective of this study is to estimate the major cytogenetic response (MCyR) rates of BMS-354825 and imatinib at 800 mg daily at 12 weeks in subjects with chronic phase Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) who have disease that is resistant to imatinib.

1) To estimate the MCyR at any time (prior to crossover) in both treatment arms2) To assess the durability of major cytogenetic response and time to MCyR prior tocross over in both treatment arms3) To estimate complete hematologic response (CHR) rate prior to crossover in bothtreatment arms.4) To assess the durability of CHR and time to CHR prior to crossover in both treatment arms5) To estimate major molecular response rates by measuring BCR-ABL transcripts inblood during treatment using quantitative RT-PCR prior to crossover6) To estimate post-crossover efficacy endpoints in subjects who cross over7) To assess the health-related quality of life in both treatment arms prior to crossover using the FACT-G8) To assess further the safety and tolerability of BMS-3548259) To collect blood samples for pharmacokinetic analysis of BMS-354825 given BIDthat will contribute to population pharmacokinetic modeling.

Information no disponible en EudraCT


1- ECOG performance status score 0 - 1 (See Appendix 1)2- Life expectancy of at least approximately 3 months3-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)4- Subjects must fulfill all of the following criteria relating to prior treatment withimatinib:A. Has not previously been treated with imatinib at a dose greater than 600 mg/dayB. Developed resistance to disease while receiving an imatinib dose 400-600 mg/dayC. Able to tolerate chronic administration of imatinib at the highest dose the subjecthas received in the past5- 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 normal 6- Adequate renal function defined as:• serum creatinine ? 1.5 times the institutional upper normal limit7- 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.8- Men and women, 18 years of age or older.

1- Women who are pregnant or breastfeeding2- WOCBP who are unwilling or unable to use an acceptable method to avoidpregnancy for the entire study period for at least 1 month before and for at least 3months after completion of the study medication.3- Prior treatment with imatinib at a dose > 600 mg4- Subjects who have previously identified BCR-ABL mutation in the following list willbe excluded (L248V, G250E, Q252H/R, Y253H/F, E255K/V, T3151/D, F317L,H369P/R).5- Previous diagnosis of accelerated phase or blast crisis CML.6- Intolerance to imatinib at any dose.7- Subjects who are eligible and willing to undergo transplantation during the screening period8- A serious uncontrolled medical disorder or active infection which would impair theability of the subject to receive protocol therapy.9- Uncontrolled or significant cardiovascular disease.10-Uncontrolled hypertension11- History of significant bleeding disorder unrelated to CML.12- Subjects who receiveda) imatinib within 7 daysb) interferon or cytarabine within 14 daysc) a targeted small molecule anti-cancer agent within 14 days, any otherinvestigational or antineoplastic agent other than hydroxyurea within 28 days before starting treatment with BMS-35482513- Subjects currently taking the drugs that are generally accepted to have a risk of causing Torsade de Pointes14- Subjects taking medications that irreversibly inhibit platelet function.15- Prior therapy with BMS-354825.16- Subjects taking medications known to be potent CYP3A4 inhibitorsor inducers17-Evidence of organ dysfunction or any clinically significant deviation from normal inphysical examination, vital signs, ECG or clinical laboratory determinations unrelatedto CML that, in the judgment of the Investigator, would jeopardize subject safetyduring participation in this study.

EfficacyThe primary endpoint in this study is MCyR rates, at 12 weeks, to BMS-354825 and to imatinib at 800 mg daily. MCyR rate at 12 weeks is defined as the proportion of all randomized subjects at 12 weeks with best response of complete cytogenetic response (CCyR) or partial cytogenetic response (PCyR).The secondary efficacy endpoints include MCyR rate at any time prior to cross over, CHR rates, duration of MCyR and CHR, time to MCyR and CHR prior to crossover for both arms.Safety/ToxicityAnalysis of safety will be performed on the dataset of all treated patients, by arm astreated for events that have occurred prior to crossover. In addition, safety analyses will be conducted for events that have occurred after crossover on the dataset of subjects that have crossed-over to Imatinib and, separately, on the dataset of subjects that have crossed over to BMS-354825. Descriptive statistics will be employed in the analysis of all safety and laboratory observations in this study.Other secondary endpoints include pharmacokinetics.

Fase II
  DISEÑO DEL ENSAYO:

Si
Si

Si
No

No
No

Si
No
  COMPARADOR DEL ENSAYO CONTROLADO:

Si
No

No
No

Si

Centros participantes:


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

2
0
  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:


6

Para estudios internacionales:


71
180

Investigadores

  INVESTIGADORES QUE PARTICIPAN EN EL ESTUDIO

Estado actual


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