Hemotrial Un proyecto de SEHH

Ensayo clínico

A PHASE II, MULTICENTER, OPEN-LABEL TRIAL EVALUATING THE ACTIVITY AND TOLERABILITY OF ROMIDEPSIN (DEPSIPEPTIDE, FK228) IN PROGRESSIVE OR RELAPSED PERIPHERAL T-CELL LYMPHOMA FOLLOWING PRIOR SYSTEMIC THERAPYESTUDIO EN FASE II, MULTICÉNTRICO Y ABIERTO PARA EVALUAR LA ACTIVIDAD Y TOLERABILIDAD DE ROMIDEPSINA (DEPSIPÉPTIDO,FK228) EN LINFOMA DE CÉLULAS T PERIFERICAS (LCTP) EN PROGRESIÓN O EN RECAIDA DESPUÉS DE UNA TERAPIA SISTÉMICA PREVIA

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Resumen

2017-03-15 04:02:35
2006-006228-21
GPI-06-0002
A PHASE II, MULTICENTER, OPEN-LABEL TRIAL EVALUATING THE ACTIVITY AND TOLERABILITY OF ROMIDEPSIN (DEPSIPEPTIDE, FK228) IN PROGRESSIVE OR RELAPSED PERIPHERAL T-CELL LYMPHOMA FOLLOWING PRIOR SYSTEMIC THERAPYESTUDIO EN FASE II, MULTICÉNTRICO Y ABIERTO PARA EVALUAR LA ACTIVIDAD Y TOLERABILIDAD DE ROMIDEPSINA (DEPSIPÉPTIDO,FK228) EN LINFOMA DE CÉLULAS T PERIFERICAS (LCTP) EN PROGRESIÓN O EN RECAIDA DESPUÉS DE UNA TERAPIA SISTÉMICA PREVIA
Depsipeptide in PTCL
GPI-06-0002

PROMOTORES DEL ENSAYO
Nombre del promotor Organización Persona de contacto País
Gloucester Pharmaceuticals Inc. United States

Fármacos

  INFORMACIÓN DE FÁRMACOS USADOS:
  FÁRMACO 1:
Test
Romidepsin
FK228 Powder for solution for infusion
Intravenous use

Detalles del Fármaco (Principio Activo):
FK228 / FR90122 Depsipeptide

Concentración del fármaco:
mg/ml milligram range

0.02 to 0.10

Contenido del fármaco

No
Si

No
Information no disponible en EudraCT

No
No

No
No

Information no disponible en EudraCT
No

No
No

No
  INFORMACIÓN DE PLACEBOS USADOS:

No hay placebos asignados al ensayo

Información General


 Recaida

Linfomas y otros Síndromes Linfoproliferativos

Progressive or relapsed Peripheral T-Cell Lymphoma (PTCL)

The primary objective of this trial is to evaluate the activity of romidepsin in patients with progressive or relapsed PTCL following prior systemic therapy. The primary efficacy parameter is the rate of complete response, defined as the proportion of patients with complete response (CR) and unconfirmed complete response [CR(u)] according to the IWC for responses assessment for non-Hodgkin’s lymphomas (NHL).

• To estimate the rate of objective disease response (ORR), defined as the proportion of patients with CR, CR(u), and partial response (PR);• To estimate the duration of response, defined as the time from the first date of a disease response to the date of diagnosis of progressive disease (PD) or date of last study assessment if there is no disease progression;• To estimate the time to objective disease progression; • To assess tolerability and safety of romidepsin; and• To estimate the change in Eastern Cooperative Oncology Group (ECOG) performance status.

No


• Histologically confirmed PTCL NOS, angioimmunoblastic T-cell lymphoma, extranodal NK/T-cell lymphoma nasal type, enteropathy- type T-cell lymphoma, subcutaneous panniculitis-like T-cell lymphoma, cutaneous ?? T-cell lymphoma, hepatosplenic T-cell lymphoma, ALCL (ALK-1 negative), or patients with ALK 1 expressing ALCL (ALK-1 positive) who have relapsed disease after ASCT;• Age ?18 years;• Written informed consent (see Appendix A);• PD following at least one systemic therapy or refractory to at least one prior systemic therapy;• Measurable disease according to the IWC criteria (see Appendix B) and/or measurable cutaneous disease;• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 (see Appendix C);• Serum potassium ?3.8 mmol/L and magnesium ?0.85 mmol/L (electrolyte abnormalities can be corrected with supplementation to meet inclusion criteria);• Negative urine or serum pregnancy test on females of childbearing potential; and• All women of childbearing potential must use an effective barrier method of contraception (either an intrauterine contraceptive device [IUCD] or double barrier method using condoms or a diaphragm plus spermicide) during the treatment period and for at least 1 month thereafter. Male patients should use a barrier method of contraception during the treatment period and for at least 1 month thereafter. Hormonal methods of contraception such as the contraceptive pill or patch (particularly those containing ethinyl-estradiol) should be avoided due to a potential drug interaction

• Known central nervous system (CNS) lymphoma [computed tomography (CT) or magnetic resonance imaging (MRI) scans are required only if brain metastasis is suspected clinically];• Chemotherapy or immunotherapy within 4 weeks of study entry (6 weeks if nitrosoureas given);• Concomitant use of any other anti-cancer therapy;• Concomitant use of any investigational agent;• Use of any investigational agent within 4 weeks of study entry;• Any known cardiac abnormalities such as:o Congenital long QT syndrome;o QTcF interval >480 milliseconds (msec);o A myocardial infarction within 12 months of study entry;o Other significant ECG abnormalities including 2nd atrio-ventricular (AV) block type II, 3rd degree AV block, or bradycardia (ventricular rate less than 50 beats/min).o A history of coronary artery disease (CAD), e.g., angina Canadian Class II-IV . In any patient in whom there is doubt, the patient should have a stress imaging study and, if abnormal, angiography to define whether or not CAD is present;o An ECG recorded at screening showing significant ST depression (ST depression of ?2 mm, measured from isoelectric line to the ST segment at a point 60 msec at the end of the QRS complex). If in any doubt, the patient should have a stress imaging study and, if abnormal, angiography to define whether or not CAD is present;o Congestive heart failure (CHF) that meets New York Heart Association (NYHA) Class II to IV definitions (see Appendix F) and/or ejection fraction <40% by MUGA scan or <50% by echocardiogram and/or MRI; o A known history of sustained ventricular tachycardia (VT), ventricular fibrillation (VF), Torsade de Pointes, or cardiac arrest unless currently addressed with an automatic implantable cardioverter defibrillator (AICD);o Hypertrophic cardiomyopathy or restrictive cardiomyopathy from prior treatment or other causes (if in doubt, see ejection fraction criteria above);o Uncontrolled hypertension, i.e., blood pressure (BP) of ?160/95; oro Any cardiac arrhythmia requiring anti-arrhythmic medication;• Serum potassium <3.8 mmol/L or serum magnesium <0.85 mmol/L (electrolyte abnormalities can be corrected with supplementation to meet inclusion criteria); • Concomitant use of drugs that may cause a prolongation of the QTcF (see Appendix G);• Concomitant use of CYP3A4 inhibitors (see Appendix D);• Concomitant use of warfarin due to a potential drug interaction;• Clinically significant active infection; • Known infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C; • Previous extensive radiotherapy involving ?30% of bone marrow (e.g., whole pelvis, half spine), excluding patients who have had total body irradiation as part of a conditioning regimen for ASCT; • Major surgery within 2 weeks of study entry;• Previous allogeneic stem cell transplant;• Inadequate bone marrow or other organ function as evidenced by:o Hemoglobin <9 g/dL (transfusions and/or erythropoietin are permitted);o Absolute neutrophil count (ANC) ?1.0 × 109 cells/L [patients with neutropenia (ANC 1–1.5) as a function of their disease may be supported with granulocyte-colony stimulating factor (G-CSF)];o Platelet count <100 × 109 cells/L or platelet count <75 × 109 cells/L if bone marrow disease involvement is documented;o Total bilirubin >2.0 × upper limit of normal (ULN) or >3.0 × ULN in the presence of demonstrable liver metastases; o Aspartate transaminase/serum glutamic oxaloacetic transaminase (AST/SGOT) and alanine transaminase/serum glutamic pyruvic transaminase (ALT/SGPT) >2.0 × ULN or >3.0 × ULN in the presence of demonstrable liver metastases; oro Serum creatinine >2.0 × ULN; • Patients who are pregnant or breast-feeding;• Coexistent second malignancy or history of prior malignancy within previous 5 years (excluding basal or squamous cell carcinoma of the skin, and in situ carcinoma of the cervix (CIN 1) that has been treated curatively); • Any significant medical or psychiatric condition that might prevent the patient from complying with all study procedures; or• Prior exposure to romidepsin (other HDAC inhibitors are allowed).

• CR (Complete Response) : For the purposes of reviewing radiology, CR is defined as the complete disappearance of all radiographic evidence of disease. All large Nodal Index lesions (identified as abnormal lymph nodes or nodal masses > 15mm at baseline) must have decreased to ?15 mm in their greatest diameter. All small Nodal Index lesions (identified as abnormal lymph nodes or nodal masses between 11mm and 15mm at baseline) must have decreased to ?10 mm in their greatest diameter or,in aggregate, those lesions must have regressed >75% in their SPD compared to baseline. If the spleen or liver is considered to have been enlarged before therapy due to involvement by lymphoma, it must have regressed in size. Any macroscopic nodules detectable in any organs should no longer be present. • CR(u) (Complete Response unconfirmed): Includes all the criteria for CR listed above except that all Nodal Index lesions (large or small) must have regressed > than 75% in the SPD from baseline. Individual nodes that were previously confluent must have regressed by > 75% in their SPD compared to the SPD of the original mass. • PR (Partial Response): Requires all of the following: 1) ?50% decrease in SPD of the six largest dominant nodes or nodal massess; 2) Extranodal Index lesions must also decrease by ?50% from baseline in their SPD (can include hepatic and splenic nodules); 3) no obvious increase in the size of Non-Index lesions, liver, or spleen; and 4) no new sites of disease (defined as no new node >10 mm in greatest diameter and no newly detectable lesions). • SD (Stable Disease): To be considered SD, lesions must not meet the criteria for PR listed above, and should not qualify for PD.• PD (Progressive Disease) : Requires either of the following: 1) Appearance of any new lesion defined as a new node >10 mm in greatest diameter or a newly detectable extranodal lesion;

Fase II
  DISEÑO DEL ENSAYO:

No
No

No
Information no disponible en EudraCT

Information no disponible en EudraCT
Information no disponible en EudraCT

Information no disponible en EudraCT
Information no disponible en EudraCT
  COMPARADOR DEL ENSAYO CONTROLADO:

Information no disponible en EudraCT
Information no disponible en EudraCT

Information no disponible en EudraCT
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:

20

Para estudios internacionales:

85
100

Investigadores

  INVESTIGADORES QUE PARTICIPAN EN EL ESTUDIO

Estado actual


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En Marcha