Hemotrial Un proyecto de SEHH

Ensayo clínico

Estudio multicéntrico y abierto con Belinostat en pacientes con linfoma de células T periféricas (PTCL) reincidente o refractario.A Multicenter, Open-Label Trial of Belinostat in Patients with Relapsed or Refractory Peripheral T-Cell Lymphoma

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Resumen

2017-03-15 04:09:49
2008-005843-40
PXD101-CLN-19
Estudio multicéntrico y abierto con Belinostat en pacientes con linfoma de células T periféricas (PTCL) reincidente o refractario.A Multicenter, Open-Label Trial of Belinostat in Patients with Relapsed or Refractory Peripheral T-Cell Lymphoma
Belinostat PTCL
PXD101-CLN-19

PROMOTORES DEL ENSAYO
Nombre del promotor Organización Persona de contacto País
Topotarget A/S Denmark

Fármacos

  INFORMACIÓN DE FÁRMACOS USADOS:
  FÁRMACO 1:
Test
PXD101
PXD101 Concentrate for solution for infusion
Intravenous use

Detalles del Fármaco (Principio Activo):
PXD101

Concentración del fármaco:
mg/ml milligram equal

50

Contenido del fármaco

Si
No

No
Information no disponible en EudraCT

No
No

No
No

Information no disponible en EudraCT
No

No
No

Si
  INFORMACIÓN DE PLACEBOS USADOS:

No hay placebos asignados al ensayo

Información General

Linfomas y otros Síndromes Linfoproliferativos

Patients with Relapsed or Refractory Peripheral T-Cell LymphomaLinfoma periférico de células T recurrente o resistente.

The primary objective of this study is to determine the objective response rate in patients with peripheral T cell lymphoma who are treated with belinostat monotherapy.

- safety of belinostat monotherapy- time to response- duration of response- time to progression (TTP)- progression-free survival (PFS)- one-year progression-free rate- one-year survival rate- overall survival (OS)Additional objectives are to assess:- population pharmacokinetics- patient and tumor characteristics that might distinguish responding from non-responding patients and factors associated with potential acquired drug resistance - patient baseline characteristics, including laboratory values, that might distinguish patients with differing safety profiles (correlative studies)- medical care utilization during treatment with belinostat monotherapy

No


1. A histologically confirmed diagnosis of PTCL based on pathology review at the local institution, using the most recent edition of the WHO Classification of Tumors of Haematopoietic and Lymphoid Tissues as guidance leading to the diagnosis 2. Pathology material must be available at the site for each patient before enrolment so that it can be sent to the Sponsor (or designee) for central pathology review.3. Patients must have relapsed or refractory disease after at least one prior systemic anticancer regimen. Systemic anticancer therapy is defined as chemotherapy or immunotherapy administered systemically.4. Patients must have at least one site of disease measurable in two dimensions by computed tomography (CT).5. Age ? 18 years.6. Laboratory status as follows:a. Absolute neutrophil count ? 1.0 x 109/L, platelets ? 50 x 109/L.b. Total bilirubin ?1.5 x upper normal limit, or ? 3 x upper normal limit if documented hepatic involvement with lymphoma, or ? 5 x upper normal limit if history of Gilbert?s Disease.c. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ? 2.5 x upper normal limit (? 5 x upper normal limit if documented hepatic involvement with lymphoma).d. Serum potassium within normal range.e. Calculated creatinine clearance ? 45 mL/min/1.73 m2 based on Cockcroft and Gault?s method (Cockcroft 1976).f. PT or INR, and APTT ? 1.5 x upper limit of normal unless patient is receiving anticoagulants. If patient is on anticoagulation therapy, levels should be within therapeutic range.7. Eastern Cooperative Oncology Group (ECOG) performance status 0-2.8. Estimated life expectancy greater than 3 months.9. Negative pregnancy test for women of childbearing potential.10. Signed informed consent form approved by the local Ethics Committee or Institutional Review Board.

1. Any use of anticancer therapies within 2 weeks prior to initiation of study treatment; in addition, patients should have recovered from prior treatment-related toxicities and meet laboratory and ECOG criteria for inclusion.2. Any use of investigational therapies within 3 weeks prior to initiation of study treatment.3. Major surgery within 2 weeks of study drug administration.4. Relapse within 100 days of autologous or allogeneic bone marrow transplant.5. Prior HDAC inhibitor therapy. 6. Patients with a diagnosis of:? Precursor T-cell lymphoma or leukemia? Adult T-cell lymphoma/leukemia (ATLL) ? T-cell prolymphocytic leukemia? T-cell large granular lymphocytic leukemia? Primary cutaneous type anaplastic large cell lymphoma? Mycosis fungoides/Sezary syndrome7. Co-existing active infection or any medical condition likely to interfere with trial procedures.8. Significant cardiovascular disease (New York Heart Association Class III or IV cardiac disease), myocardial infarction within the past 6 months, unstable angina, unstable arrhythmia or a need for anti-arrhythmic therapy (use of frequency adjusting medication for atrial fibrillation is allowed, if stable medication for at least last month prior to randomization and medication not listed as causing Torsade de Points, see Section 16.2, Appendix B), or evidence of acute ischemia on ECG.9. Baseline prolongation of QT/QTc interval, i.e., demonstration of a QTc interval > 450 msec; Long QT Syndrome; the required use of concomitant medication that may cause Torsade de Pointes (see Section 16.2 Appendix B for list of such medications). 10. Clinically significant central nervous system disorders with altered mental status or psychiatric disorders precluding understanding of the informed consent process and/or completion of the necessary studies.11. Active concurrent malignancy (except adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix). If there is a history of prior malignancy, the patient must be disease free for greater than or equal to 2 years (except carcinoma in situ of breast, prostate cancer, or superficial bladder cancer).12. Symptomatic or untreated central nervous system (CNS) metastases. Patients with previously treated CNS metastases which are asymptomatic at baseline are permitted. 13. Pregnant or breast-feeding women.14. Women of childbearing age and potential who are not willing to use effective contraception during the study and until 30 days after last dose of study drug. Male patients or male patients who have female partners of childbearing age and potential who are not willing to use effective contraception during the study and until 30 days after last dose of study drug. Highly effective methods of birth control are defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner.15. Known infection with HIV, hepatitis B or hepatitis C.16. Patients that are not affiliated with social security (study centers in France only)

The primary study endpoint is objective response rate (ORR), defined as complete response (CR) or partial response (PR) based on independent radiology review.

Fase II
  DISEÑO DEL ENSAYO:

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

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:

6
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:

12

Para estudios internacionales:

42
120

Investigadores

  INVESTIGADORES QUE PARTICIPAN EN EL ESTUDIO

Estado actual


 Por Determinar



En Marcha