Hemotrial Un proyecto de SEHH

Ensayo clínico

Ensayo de agente único en fase II sobre la forodesina (BCX1777) en el tratamiento del linfoma cutáneo de células T

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Resumen

2017-03-15 04:05:04
2007-002093-60
BCX1777-203
Ensayo de agente único en fase II sobre la forodesina (BCX1777) en el tratamiento del linfoma cutáneo de células T
forodesine in CTCL
BCX1777-203

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

Fármacos

  INFORMACIÓN DE FÁRMACOS USADOS:
  FÁRMACO 1:
Test
Forodesine hydrochloride
BCX1777 Capsule*
Oral use

Detalles del Fármaco (Principio Activo):

BCX1777 forodesine

Concentración del fármaco:

mg milligram(s) equal

100

Contenido del fármaco


Si
No

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



Linfomas y otros Síndromes Linfoproliferativos

linfoma cutáneo de células T (CTCLs)


The primary objective is to determine the objective response rate to treatment with oral forodesine in subjects with cutaneous manifestations of CTCL, stages IIb, III and IVa.

The secondary objectives are:1. To assess the safety and tolerability of daily administration of oral forodesine in this population;2. To determine the time to objective response in subjects with CTCL having cutaneous manifestations of the disease;3. To determine the duration of objective response in subjects with CTCL having cutaneous manifestations of the disease;4. To determine the loss of objective response;5. To determine the objective response rate of extracutaneous manifestations of CTCL (lymph node enlargement, Sezary cells in peripheral blood).6. To determine the time to objective response and duration of objective response of extracutaneous manifestations of CTCL in subjects who have extracutaneous manifestations of disease; and,7. To determine subjects' assessments of treatment-related changes in health related quality of life (HRQoL).

No


1. Males or non-pregnant females aged ?18 years;2. Histologically confirmed diagnosis of CTCL, including mycosis fungoides and/or sezary syndrome;3. Subjects with CTCL stages IB, IIA, IIB, III or IVA who have persistent, progressive, or recurrent disease during or following treatment with at least three forms of systemic therapy, one of which must have been bexarotene, unless treatment with oral bexarotene was not tolerated or was medically contraindicated;4. Anticipated life expectancy > 6 months;5. Performance status of 0, 1, or 2 by ECOG;6. Females of childbearing potential must have a negative serum pregnancy test within 14 days prior to initiation of study treatment ;7. Females of child bearing potential and sexually active males, if indicated, must be willing and able to use method(s) of contraception that are adequate to prevent or minimize the risk of pregnancy for the duration of the study; and,8. Written informed consent to participate in the study.

CTCL-related Exclusion Criteria1. Proven or suspected extracutaneous visceral CTCL involvement (M1) (CTCL stage IVB) (note: presence of lymphadenopathy is permitted); 2. Previous treatment with forodesine;3. ECOG performance status >2;4. Concomitant use of any anti-cancer therapy or immune modifier;5. Concomitant use of any investigational agent or device;6. Concurrent treatment with any other anti-CTCL therapy, or radiation therapy. Topical corticosteroids (except classes 1 and 2 which are prohibited) or low dose oral corticosteroids (?10 mg/day prednisone or equivalent) will not be excluded, but if used, must be a stable dose and schedule during the four weeks immediately prior to study entry;7. Use of previous therapies for CTCL within the timeframes specified below:a. Phototherapy in the previous 30 days;b. Electron beam therapy, photopheresis, systemic anticancer therapy, interferon therapy, or other investigational therapy in the previous 30 days;c. Oral retinoid (including bexarotene) in the previous 30 days;d. Alemtuzumab (Campath) or other monoclonal antibody within the previous 30 dayse. Vorinostat or other HDAC inhibitor within previous 30 daysf. Any investigational therapy within the previous 30 days;Hepatic/Renal/Metaboli Exclusion Criteria8. ALT or AST >3 times ULN or alkaline phosphatase >2 times ULN;9. Calculated creatine clearance ?50mL/min or serum creatine ?1.8mg/dL;10. Serum potassium <3.3mg/dL or >5.5mg/dL;11. Evidence of clinically significant (uncontrolled) hypo- or hyperthyroidism;Cardiovascular Exclusion Criteria12. Recent (in past 6 months) medically significant cardiac event (i.e., myocardial infarction, cardiac surgery);13. Presence of congestive heart failure (NYHA class IV) or angina (NYHA class IV) or presence of a medically significant dysrhythmia;14. Presence of any of the following ECG findings:a. Congenital long QT syndrome;b. QTc interval >480 msec (Bazett’s correction);15. Presence of uncontrolled hypertension manifested by systolic blood pressure ?160mmHg and or diastolic blood pressure ?90mmHg;Hematologic Exclusion Criteria16. Hemoglobin <9.0gm/dL (intermittent red blood cell transfusions permitted);17. Absolute neutrophil count <1500cells/mm^3;18. Platelet count <75,000/mm^3;19. Requirement for neutrophil or platelet growth factor therapy or administration of such therapy in the previous 30 days;20. CD4 count <200/mm^3Infection-Related Exclusion Criteria21. Documented current active infection with HIV, Hepatitis B, Hepatitis C and/or CMV;22. Presence of uncontrolled bacterial or viral infection (subject may be receiving chronic antimicrobial therapy); or,23. History of culture-documented bacteremia in the previous 2 weeks.General Exclusion Criteria24. Recent (i.e., in past 2 weeks) change in doses or regimens of medications used for any chronic non-oncologic condition for reasons of worsening of the chronic illness (change in doses of chronic medications associated with improvement in a chronic illness are not exclusionary);25. Presence of any acute or chronic non-oncologic disease which, in the opinion of the investigator, is medically uncontrolled;26. coexistent second malignancy or history of prior malignancy within 5 years [excluding basal cell or squamous cell carcinoma of skin and cervical neoplasia (carcinoma in situ) that has been treated curatively]. Surgically resected nonmelanomatous skin cancer (non-CTCL) with no evidence of recurrence in 6 months is permitted; and,27. Any significant medical or psychiatric condition that in the opinion of the investigator, might prevent the subject from complying with all required study procedures.

The primary end point is an assessment of objective response (OR) for each patient, defined as either complete cutaneous response (CR) or partial cutaneous response (PR), in subjects with CTCL Stages IIB, III, or IVA. Cutaneous response will be determined by use of a modified severity weighted assessment tool (mSWAT). Objective response will be defined as either no evidence of clinical disease or a marked improvement that is ?50% decrease in mSWAT score compared to Baseline. Confirmation of objective response will be required by a second assessment after at least 28 days. At the time of confirmation of OR, CT scans (neck, chest, abdomen and pelvis) should be performed to confirm the absence of progression of any pre-existing lymph node disease involvement. Cutaneous disease manifestations will be documented by serial standardised body photgraphy and skin assessment worksheets.

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
Si

No

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:


10

Para estudios internacionales:


40
150

Investigadores

  INVESTIGADORES QUE PARTICIPAN EN EL ESTUDIO

Estado actual


EC Finalizado



EC Finalizado