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Ensayo clínico

Estudio de fase I/II abierto con aumento de la dosis para investigar la seguridad y tolerabilidad de acadesina en pacientes con leucemia linfocítica crónica de células B

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Resumen

2017-03-15 04:05:14
2007-002557-23
PR015-CLN-pro001
Estudio de fase I/II abierto con aumento de la dosis para investigar la seguridad y tolerabilidad de acadesina en pacientes con leucemia linfocítica crónica de células B
PR015-CLN-pro001

PROMOTORES DEL ENSAYO
Nombre del promotor Organización Persona de contacto País
Protherics Medicines Development Ltd United Kingdom

Fármacos

  INFORMACIÓN DE FÁRMACOS USADOS:
  FÁRMACO 1:
Test
Acadesine
Solution for infusion
Intravenous use

Detalles del Fármaco (Principio Activo):
Acadesine

Concentración del fármaco:
mg/ml milligram equal

50

Contenido del fármaco

No
Si

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

pacientes con leucemia linfocítica crónica de células B

To demonstrate the safety and tolerability of acadesine in patients with B-CLL.

To determine the pharmacokinetics of acadesine and its metabolite, ZMP.To determine the optimal biological dose of acadesine in patients with B-CLL.

No


• B-CLL patients with refractory or relapsed disease who have received either a fludarabine containing treatment regimen or an alkylating agent.• Diagnosis of B-CLL according to NCI Working Group Criteria.• Have an elevated B-cell count of ? 5000/mm3. • Have a T-cell count ? 200/mm3.• ECOG Performance Status < 2.• Have a life expectancy of at least 3 months.• Age > 18 years, of either gender.• Have given written informed consent, prior to any study related procedure not part of the patient’s normal medical care.

• Patients who, in the opinion of the Investigator, need immediate treatment with proven chemotherapy and/or immunotherapy, and/or transplantation.• Have B-CLL with central nervous system involvement.• Have participated in any other investigational drug study or have undergone an experimental therapeutic procedure considered to potentially interfere with the study in the 30 days preceding Day 1.• Have received chemotherapy or radiotherapy treatment in the 30 days preceding Day 1.• Require use of drugs or substances which inhibit platelet aggregation during the 30 days prior to Day 1 or during the study. These include: ADP receptor inhibitors (ticlopidine, clopidogrel), aspirin and other NSAIDs including COX inhibitors (except COX-2-selective inhibitors), dipyridamole, phosphodiesterase inhibitors (cilostazol), calcium channel blockers such as nifedipine, xanthines (eg theophylline, aminophylline) and substances containing caffeine. Glycoprotein IIB/IIIA inhibitors, including abciximab, eptifibatide and tirofiban, are also contraindicated.• Require oral or parenteral steroids with the exception of inhaled steroids or low-dose oral steroids (<10mg prednisolone per day or equivalent) for an indication other than B-CLL. • Have a serious medical or psychiatric condition that could, in the Investigator’s opinion, potentially interfere with their treatment and/or participation in the study. • Have uncontrolled diabetes mellitus that requires insulin treatment or is not controlled on oral therapy. • Have a history of gout. • Have a serious concomitant disease including:o Significant cardiac disease - New York Heart Association Classes III or IV or have suffered a myocardial infarction in the last 6 months. o Chronic pulmonary obstructive disease with hypoxemia.o Clinically active auto-immune disease. o Active infection such as tuberculosis, CMV (Cytomegalovirus).• Any secondary malignancy requiring active treatment (except hormonal therapy).• Have inadequate bone marrow reserve: neutrophils < 1.0 x 109/L, platelet count < 50 x 109/L (unsupported by transfusion), or coagulation abnormalities.• Have inadequate liver function: total bilirubin > 1.5 x upper limit of normal values (ULN), AST, ALT, or alkaline phosphatase > 2.5 x ULN. • Have inadequate renal function, defined by serum creatinine ? 1.5 x ULN, unless creatinine clearance is measured and found to be at least 90 mL/min. • Have serum uric acid levels outside the normal range.• Females of childbearing potential who are unwilling to employ adequate means of contraception (hormonal contraceptive, intrauterine device, diaphragm with spermicide or condom with spermicide) for the duration of the study and 30 days after the last acadesine administration.• Pregnant or lactating females.• Male patients who are not surgically sterile and who are unwilling to use a condom with spermicide for the duration of the study and for 3 months after the last acadesine administration.• Abuse of alcohol or other recreational drugs.• Known HIV or Hepatitis B (unless clearly due to vaccination) or C positive.• Known allergy to acadesine or any of its excipients. • Have undergone previous allogeneic stem cell transplant.• Transformation to Richter’s syndrome or other aggressive B-cell malignancy.

• Safety and tolerability: adverse events and serious adverse events (incidence, causality, severity), local tolerability, changes in laboratory values (including liver enzymes, blood glucose and uric acid) and vital signs. Adverse events will be assessed for their relationship to acadesine and classified for severity according to the NCI CTCAE v3.0.• Pharmacokinetics: pharmacokinetic profile of acadesine in plasma and its metabolite, ZMP, in whole blood. • Pharmacodynamics: the effects of acadesine on B-cell and T-cell counts in peripheral blood.

Fase IFase 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:

1
6
  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:

8

Para estudios internacionales:

40
40

Investigadores

  INVESTIGADORES QUE PARTICIPAN EN EL ESTUDIO

Estado actual


 Por Determinar



En Marcha