EUCTR2004-002290-22-DE进行中（未招募）不适用
Phase II open-label study to investigate the efficacy and safety of PTK787/ZK222584 orally administered once daily or twice daily at a total daily dose of 1250 mg as second-line monotherapy in patients with Stage IIIB or Stage IV non-small-cell lung cancer (NSCLC) - Efficacy and safety of PTK787/ ZK 222584 1250 mg daily as 2nd line monotherapy in NSCLC
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Schering AG
- 入组人数
- 110
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 females aged at least 18 years or greater
- •2. Histologically or cytologically proven NSCLC, Stage IIIB or Stage IV
- •3. One and only 1 prior first-line chemotherapy or chemo-radiotherapy regimen
- •4. At least 1 measurable lesion as per RECIST criteria (see Section Attachment 4)
- •5. World Health Organization (WHO) performance status of 0 to 1
- •6. Function of major organ systems:
- •a. Hematopoietic:
- •- Hemoglobin: greater than or equal to 9 g/dL
- •- Absolute neutrophil count: greater than or equal to 1,500/mm3
- •- Platelet count: greater than or equal to 100,000/mm3
- •b. Hepatic:
- •- Bilirubin: less than or equal to 1.5 times the upper limit of normal (ULN)
- •- AST/ALT: less than or equal to 2.5 times the ULN
- •(less than or equal to 5 times the ULN if liver metastases are present)
- •- Creatinine: less than or equal to 1.5 times the ULN
- •- Urinalysis: negative for proteinuria;
- •d. No other uncontrolled concurrent illness
- •7. Life expectancy greater than or equal to 3 months
- •8. Negative pregnancy test (females of childbearing potential only)
- •9. Agreement by male and female patients with reproductive potential, to use double barrier contraceptive methods of birth control throughout their entire participation in the study.
- •10. Written informed consent
- •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. Prior anti-VEGF therapy
- •2. Time period < 14 days between end of prior first-line therapy (not including investigational drugs) and start of study treatment
- •3. Use of investigational drugs < 4 weeks prior to start of study treatment or inadequate recovery from any toxic effects of such therapy
- •4. Surgery < 10 days prior to study enrollment (i.e., informed consent)
- •5. Inadequate recovery from previous surgery, radiation, or chemotherapy
- •6. Candidacy for curative resection
- •7. Brain metastases
- •8. Medical conditions requiring urgent intervention including, but not limited to:
- •a. Unstable and uncontrolled hypertension
- •b. Active infection
- •c. Superior vena cava syndrome
- •d. Lobar obstruction
- •e. Spinal cord compression
- •f. Hyponatremia (< 130 mmol/L)
- •g. Unstable angina pectoris
- •9. Concurrent severe and/or uncontrolled medical disease which could compromise participation in the study including, but not limited to:
- •a. Myocardial infarction within 6 months of study
- •b. Symptomatic congestive heart failure
- •c. Uncontrolled diabetes
- •d. Chronic renal disease
- •e. Acute or chronic liver disease other than liver metastases (e.g., hepatitis, cirrhosis)
- •f. Psychiatric illness/social situations that would limit study participation
- •10. Confirmed diagnosis of infection with the human immunodeficiency virus (HIV)
- •11. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of PTK787/ZK 222584 (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection)
- •12. Current treatment with warfarin sodium (Coumadin) or similar anticoagulation medication
- •13. Breast feeding
- •14. Unwillingness or inability to comply with the protocol
- •15. Previous receipt of study treatment under this protocol
研究者
相似试验
进行中（未招募）
不适用
A Phase II, open-label study to assess the efficacy and tolerability of ZD6474 ZACTIMA 100 mg monotherapy in subjects with locally advanced or metastatic hereditary medullary thyroid cancer - NDocally advanced or metastatic hereditary medullary thyroid cancerMedDRA version: 9.1Level: LLTClassification code 10027105Term: Medullary thyroid cancerEUCTR2006-001354-28-ITASTRAZENECA15
进行中（未招募）
1 期
A phase 2 study to evaluate the efficacy of allogeneic human cord blood-derived mesenchymal stromal cells in pediatric patients with steroid-dependent nephrotic syndrome in maintaining remission after immunosuppressive therapy withdrawalSteroid dependent nephrotic syndromeMedDRA version: 20.0 Level: SOC Classification code 10038359 Term: Renal and urinary disorders System Organ Class: 10038359 - Renal and urinary disordersEUCTR2018-001162-42-ITFONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO11
进行中（未招募）
不适用
An open label phase II trial to assess the efficacy and safety of a once daily oral dose of 50 mg BIBW 2992 in two cohorts of patients with HER2-negative metastatic breast cancer after failure of no more than two chemotherapy regimen -HER2-negative metastatic breast cancer after failure of no more than two chemotherapy regimen in two cohorts of patientsTwo Cohorts: Cohort A: Triple negative metastatic breast cancer, i.e. HER2-negative, estrogen-receptor-negative and progesterone receptor negativeCohort B:HER2-negative, estrogen-receptor-positive and/or progesterone-receptor positiveMedDRA version: 8.1Level: LLTClassification code 10027475Term: Metastatic breast cancerEUCTR2006-002018-36-BESCS Boehringer Ingelheim Comm.V60
进行中（未招募）
不适用
An open label phase II trial to assess the efficacy and safety of a once daily oral dose of 50 mg BIBW 2992 in two cohorts of patients with HER2-negative metastatic breast cancer after failure of no more than two chemotherapy regimen -HER2-negative metastatic breast cancer after failure of no more than three chemotherapy regimen in two cohorts of patientsTwo Cohorts: Cohort A: Triple negative metastatic breast cancer, i.e. HER2-negative, estrogen-receptor-negative and progesterone receptor negativeCohort B:HER2-negative, estrogen-receptor-positive and/or progesterone-receptor positiveMedDRA version: 8.1Level: LLTClassification code 10027475Term: Metastatic breast cancerEUCTR2006-002018-36-DEBoehringer Ingelheim Pharma GmbH & Co. KG60
进行中（未招募）
1 期
An open label phase II study to evaluate the efficacy and safety of Inotuzumab Ozogamicin for Induction Therapy followed by a conventional chemotherapy based consolidation and maintenance therapy In patients aged 56 years and older with Acute Lymphoblastic leukemia (ALL).Acute lymphoblastic leukemia, Philadelphia-chromosome and BCR-ABL negative disease, patient aged 56 years or olderMedDRA version: 21.0Level: LLTClassification code 10000845Term: Acute lymphoblastic leukemiaSystem Organ Class: 100000004864EUCTR2016-004836-39-DEGoethe Universität45