EUCTR2007-002093-60-ES进行中（未招募）不适用
Ensayo de agente único en fase II sobre la forodesina (BCX1777) en el tratamiento del linfoma cutáneo de células T - forodesine in CTC
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •CTCL-related Exclusion Criteria
- •1. 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 days
- •e. Vorinostat or other HDAC inhibitor within previous 30 days
- •f. Any investigational therapy within the previous 30 days;
- •Hepatic/Renal/Metaboli Exclusion Criteria
- •8. 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 Criteria
- •12. 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 Criteria
- •16. 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^3
- •Infection-Related Exclusion Criteria
- •21. 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 Criteria
- •24. 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)
研究者
相似试验
进行中（未招募）
不适用
Ensayo en Fase I-II para evaluar la administración de radioterapia concomitante prequirúrgica y quimioterapia con satraplatin más capecitabina en el tratamiento del adenocarcinoma rectal localmente avanzado - NAAdenocarcinoma rectal localmente avanzadoMedDRA version: 9.1Level: LLTClassification code 10038049Term: Rectal cancer stage IIEUCTR2006-000081-36-ESGPC Biotech AG49
进行中（未招募）
1 期
Estudio de fase 2, intervencionista, de un solo brazo para describir la respuesta plaquetaria y las tasas de remisión de PTI en sujetos adultos con Púrpura Trombocitopénica Inmune que reciben Romiplostim.-------------------------------------------------------A Phase 2, Interventional, Single Arm Study Describing Platelet Responses and ITP Remission Rates in Adult Subjects with Immune Thrombocytopenia Purpura Receiving RomiplostimPúrpura Trombocitopénica Inmune(Idiopática) (PTI) en adultos----------------------------------Adult immune thrombocytopenic purpura (ITP)MedDRA version: 12.1Level: LLTClassification code 10021245Term: Idiopathic thrombocytopenic purpuraEUCTR2010-019987-35-ESAmgen Inc75
进行中（未招募）
1 期
Ensayo fase II, doble ciego, aleatorizado para evaluar la eficacia de AZD6244 (hidrógeno-sulfato) combinado con dacarbazina, en comparación con dacarbazina sola, como tratamiento de primera línea en pacientes con melanoma cutáneo o melanoma primario desconocido avanzado y mutación positiva de BRAFA Phase II, Double-Blind, Randomised Study to Assess the Efficacy of AZD6244 (Hyd-Sulfate) in Combination with Dacarbazine Compared with Dacarbazine Alone in First Line Patients with BRAF Mutation Positive Advanced Cutaneous or Unknown Primary Melanomamelanoma cutáneo o melanoma primario desconocido avanzado y mutación positiva de BRAFBRAF mutation positive advanced cutaneous and unknown primary melanomaMedDRA version: 9.1Level: LLTClassification code 10025654Term: Malignant melanoma of sites other than skinMedDRA version: 9.1Level: LLTClassification code 10025670Term: Malignant melanoma stage IIIMedDRA version: 9.1Level: LLTClassification code 10025671Term: Malignant melanoma stage IVMedDRA version: 9.1Level: LLTClassification code 10027152Term: Melanoma of skin (malignant)MedDRA version: 9.1Level: LLTClassification code 10027480Term: Metastatic malignant melanomaEUCTR2008-006344-19-ESAstraZeneca AB91
进行中（未招募）
1 期
FASE 2 DEL ESTUDIO PILOTO, QUE EVALUA LA INMUNOGENICIDAD Y LA SEGURIDAD DE IC43 EN PACIENTES EN LA UNIDAD DE CUIDADOS INTENSIVOS Original title: A PHASE 2 PILOT STUDY ASSESSING IMMUNOGENICITY AND SAFETY OF IC43 IN INTENSIVE CARE PATIENTS - IC43-201Infecciones nosocomiales causadas por pseudomonas aeruginosa en pacientes con ventilacion mecanica admitidos en unidades de cuidados intensivos.(Nosocomial pseudomonas aureginosa infections in mechanically ventilated ICU patients)MedDRA version: 9.1Level: PTClassification code 10061471Term: Pseudomonas infectionEUCTR2008-005037-30-ESIntercell AG450
进行中（未招募）
不适用
Ensayo fase II, abierto, de un solo brazo de tratamiento para evaluar la farmacocinética, seguridad, tolerabilidad y actividad antiviral de TMC278 en pacientes adolescentes de entre 12 y 18 años de edad infectados por el VIH-1, sin tratamiento antirretroviral previo.A Phase II, open label, single arm trial to evaluate the pharmacokinetics, safety, tolerability, and antiviral activity of TMC278 in antiretroviralnaïve HIV-1 infected adolescents aged 12 to < 18 yearsEUCTR2008-001696-30-ESTibotec Pharmaceuticals Ltd.35