EUCTR2007-005802-38-FR进行中（未招募）1 期
Efficacy and Safety of AP 12009 in Adult Patients with Recurrent or Refractory Anaplastic Astrocytoma (WHO grade III) as Compared to Standard Treatment with Temozolomide or BCNU: A Randomized, Actively Controlled, Open Label Clinical Phase III Study. - SAPPHIRE
Antisense Pharma GmbH0 个研究点目标入组 132 人开始时间: 2008年6月27日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 132
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.The patient has provided written informed consent prior to any study-related procedure.
- •2.The patient is at least 18 years of age and equal to or below 70 years.
- •3.The patient has a diagnosis of AA (WHO grade III) as confirmed by central histopathology.
- •4.The patient has a measurable lesion (> 2 cm3 in volume, central MRI review).
- •5.The lesion (or sum of lesions) does not exceed 50 cm3 in volume (central MRI review).
- •6.The tumor is localized supratentorially (central MRI review).
- •7.The patient has recurrent or refractory disease, i.e. disease has progressed after:
- •a.Initial therapy with surgery and radiotherapy
- •b.Initial therapy with surgery and radiotherapy with concomitant chemotherapy
- •c.Initial therapy with surgery and radiotherapy with concomitant chemotherapy, followed by adjuvant chemotherapy
- •d.Initial therapy with surgery and radiotherapy, followed by chemotherapy
- •8.The patient has not received more than one chemotherapy regimen. Radiation with concomitant chemotherapy, followed by adjuvant chemotherapy, is considered as one chemotherapy regimen.
- •9.The patient is eligible for chemotherapy.
- •10.The patient is on a maximum dose of 4 mg/day dexamethasone or equivalent doses for other corticosteroids, which has been stable or decreasing for at least 3 weeks prior to Screening.
- •11.The patient is male or a non-pregnant, non-lactating female.
- •12.Females of childbearing potential must have a negative beta-HCG pregnancy test at Screening. Females of childbearing potential and males must practice strict birth control.
- •13.The patient must have recovered from acute toxicity caused by any previous therapy.
- •14.The patient has a life expectancy of at least 3 months.
- •15.The patient has a Karnofsky Performance Status of at least 70%.
- •16.The patient shows adequate organ functions as assessed by the following screening laboratory values:
- •a.Adequate renal function determined by serum creatinine and urea < 2 times the upper limit of normal
- •b. Adequate liver function with ALT, AST and AP < 3 times the upper limit of normal, and bilirubin < 2.5 mg/dL
- •c.INR < 1.5 and aPTT < 1.5 x ULN
- •d.Hemoglobin > 9 g/dL
- •e.Platelet count > 100 x 10E9/L
- •f.WBC > 3 x 10E9/L
- •g.ANC > 1.5 x 10E9/L (or WBC > 3.0 x 10E9/L)
- •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
- •1.Patient unable or not willing to comply with the protocol regulations.
- •2.The patient is amenable to surgical resection of the tumor.
- •3.Tumor surgery, tumor debulking, or other neurosurgery within 30 days prior to randomization.
- •4.Radiotherapy or stereotactic (gamma knife) radiosurgery within 3 months prior to randomization.
- •5.Prior interstitial brachytherapy of the brain.
- •6.Chemotherapy, hormone therapy, or any other therapy with established or suggested anti-tumor effects within 4 weeks (nitrosoureas: 6 weeks) prior to randomization.
- •7.Prior anti-TGF-beta 2 targeted therapy.
- •8.Screening MRI shows a mass effect defined as significant impression of the ventricular system and/or a midline shift (=3 mm, central MRI review).
- •9.Participation in another clinical trial with another investigational medicinal product within 30 days prior to randomization.
- •10.History of a second independent malignant disorder within 5 years, except for carcinoma in situ of the cervix and basal cell carcinoma.
- •11.Presence of poorly controlled seizures, defined as:
- •a.Seizures, which occur frequently despite standard therapy for seizures, using drug doses, which result in maximum therapeutic drug plasma levels tolerated by the individual patient.
- •b.Seizures, which require frequent hospitalizations or other medical interventions because of their serial nature and/ or clinical symptoms.
- •c.Seizure symptoms, which significantly interfere with normal life and restrict medical treatments that are necessary for patient care.
- •12.Clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure, unstable angina, or poorly controlled arrhythmia. Myocardial infarction within 6 months prior to randomization.
- •13.Known HIV, HBV or HCV infection.
- •14.Acute viral, bacterial, or fungal infection.
- •15.Acute medical problems that may be considered to become an unacceptable risk, or any conditions, which might be contraindications for starting study treatment.
- •16.Presence of high risk for pulmonary toxicities, defined as:
- •a.Lung function: vital capacity = 70%
- •b.Status following sequential or concomitant thoracic irradiation
- •c.Increased risk for a pulmonary toxicity induced by BCNU (Carmustine). Risk factors include smoking, presence of a respiratory condition, pre-existing radiographic pulmonary abnormalities, exposure to agents that cause lung damage.
- •17.History of allergies to reagents used in this study.
- •18.Drug abuse or extensive use of alcohol.
- •19.Clinically relevant psychiatric disorders / legal incapacity or a limited legal capacity.
- •20.Concomitant treatment with yellow fever vaccine.
- •________________________________________
研究者
相似试验
进行中（未招募）
不适用
Evaluation of efficacy and safety of the new drug AP 12009 in adult patients suffering from Recurrent or Refractory Anaplastic Astrocytoma (WHO grade III) or Secondary Glioblastoma (WHO grade IV) compared to standard treatment with Temozolomide or Lomustine: A clinical study where patients will be openly and randomly assigned to one of the treatment groups to gain marketing approval for the new drug AP 12009.Recurrent or Refractory Anaplastic Astrocytoma (WHO grade III) or secondary Glioblastoma (WHO grade IV)MedDRA version: 14.0Level: PTClassification code 10018336Term: GlioblastomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.0Level: PTClassification code 10002224Term: Anaplastic astrocytomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2007-005802-38-ATAntisense Pharma GmbH180
进行中（未招募）
1 期
Evaluation of efficacy and safety of the new drug AP 12009 in adult patients suffering from Recurrent or Refractory Anaplastic Astrocytoma (WHO grade III) or Secondary Glioblastoma (WHO grade IV) compared to standard treatment with Temozolomide or Lomustine: A clinical study where patients will be openly and randomly assigned to one of the treatment groups to gain marketing approval for the new drug AP 12009.EUCTR2007-005802-38-GBAntisense Pharma GmbH180
招募中
3 期
Efficacy and Safety of AP 12009 in Adult Patients with Recurrent or Refractory Anaplastic Astrocytoma (WHO grade III) as Compared to Standard Treatment with Temozolomide or BCNU: A Randomized, Actively Controlled, Open Label Clinical Phase III Study.CTRI/2009/091/000171Antisense Pharma GmbH
进行中（未招募）
不适用
Evaluation of efficacy and safety of the new drug AP 12009 in adultpatients suffering from Recurrent or Refractory Anaplastic Astrocytoma(WHO grade III) or Secondary Glioblastoma (WHO grade IV) comparedto standard treatment with Temozolomide or Lomustine: A clinical studywhere patients will be openly and randomly assigned to one of thetreatment groups to gain marketing approval for the new drug AP12009.Recurrent or Refractory Anaplastic Astrocytoma (WHO grade III) or secondary Glioblastoma (WHO grade IV)MedDRA version: 14.0Level: PTClassification code 10018336Term: GlioblastomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.0Level: PTClassification code 10002224Term: Anaplastic astrocytomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2007-005802-38-HUAntisense Pharma GmbH180
进行中（未招募）
不适用
Evaluation of efficacy and safety of the new drug AP 12009 in adult patients suffering from Recurrent or Refractory Anaplastic Astrocytoma (WHO grade III) or Secondary Glioblastoma (WHO grade IV) compared to standard treatment with Temozolomide or Lomustine: A clinical study where patients will be openly and randomly assigned to one of the treatment groups to gain marketing approval for the new drug AP 12009.Recurrent or Refractory Anaplastic Astrocytoma (WHO grade III) or secondary Glioblastoma (WHO grade IV)MedDRA version: 14.0Level: PTClassification code 10018336Term: GlioblastomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.0Level: PTClassification code 10002224Term: Anaplastic astrocytomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2007-005802-38-DEAntisense Pharma GmbH180