EUCTR2007-005802-38-DE进行中（未招募）不适用
Efficacy and Safety of AP 12009 in Adult Patients with Recurrent or Refractory Anaplastic Astrocytoma (WHO grade III) or Secondary Glioblastoma (WHO grade IV) as Compared to Standard Chemotherapy: A Randomized, Actively Controlled, Open Label Clinical Phase III Study. - SAPPHIRE
Antisense Pharma GmbH0 个研究点目标入组 180 人开始时间: 2009年8月4日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 180
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 present diagnosis of AA or secondary GBM.
- •4. The patient has a measurable lesion (> 1 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. All patients have recurrent or refractory disease, i.e. disease has progressed after:
- •Prior surgery and radiotherapy at any time of the disease course or stage (e.g. prior grade II tumor).
- •Secondary GBM patients have progressed after a previous diagnosis of A and/or AA.
- •In case of recent tumor surgery a = 48-hour routine post-surgery MRI (in accordance with study specifications) confirming inclusion criteria 4, 5, and 6 qualifies the patient for study randomization 30 ± 7 days after surgery.
- •8. The patient has not received more than 2 chemotherapy regimens. 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 (see Section 8.2).
- •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 1 000 000 000/L
- •f. WBC > 3 x 1 000 000 000/L
- •g. ANC > 1.5 x 1 000 000 000/L (or WBC > 3.0 x 1 000 000 000/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 117
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 63
排除标准
- •1. Patient unable or not willing to comply with the protocol regulations.
- •2. The investigator deems it necessary to surgically (re-)resect the present tumor (NOTE: the patient might still be eligible for randomization at a later timepoint, see inclusion criterion 7 and exclusion criterion 3).
- •3. Tumor surgery, tumor debulking, or other neurosurgery within 3 months prior to randomization. If a = 48-hour routine post-surgery MRI (in accordance with study specifications) qualifies the patient for study participation (see inclusion criterion 7), the patient can be randomized 30 ± 7 days post-surgery.
- •4. Radiotherapy or stereotactic (gamma knife) radiosurgery within 3 months prior to randomization.
- •5. Prior interstitial brachytherapy of the brain with permanent implants. Prior interstitial brachytherapy of the brain with removable implants within 3 months prior to randomization.
- •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 caused by the tumor defined as significant compression of the ventricular system and/or a midline shift ( = 3 mm, central MRI review). Compression of the ventricular
- •system and/or a midline shift = 3 mm only due to the presence of (a) cyst(s) or scarring processes does not exclude an individual from the study.
- •9. Participation in another clinical study 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 require frequent hospitalizations or other medical interventions because of their serial nature and/or clinical symptoms.
- •b. 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. 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) or CCNU (Lomustine). Risk
- •factors include smoking, presence of a respiratory condition, pre-existing radiographic pulmonary
- •abnormalities, exposure to agents that cause lung damage.18. Drug abuse or extensive use of alcohol.
- •17. History of allergies to reagents used in this study, history of coeliac disease (gluten intolerance).
- •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
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