EUCTR2010-024292-30-GB进行中（未招募）不适用
A Phase II Study of PM01183 as Second-line Treatment in Patients with Metastatic Pancreatic Cancer
Pharma Mar, S.A. Sociedad Unipersonal0 个研究点目标入组 43 人开始时间: 2011年3月10日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 43
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. Voluntary written informed consent (IC) of the patient obtained before any study-specific procedure.
- •2. Histologically or cytologically confirmed cancer of the exocrine pancreas.
- •3. Stage IV disease.
- •4. Patient must have progressed during or after one prior line of gemcitabine-based therapy.
- •5. Age = 18 and = 75 years.
- •6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) = 1.
- •7. Adequate hematological, renal, metabolic and hepatic function.
- •a. Hemoglobin = 9 g/dl (patients may have received prior red blood cell [RBC] transfusion, if clinically indicated); absolute neutrophil count (ANC) = 1.5 x 109/l, and platelet count = 80 x 109/l
- •b. Alanine aminotransferase (ALT), and aspartate aminotransferase (AST) = 3.0 x upper limit of normality (ULN) (= 5.0 ULN if liver metastases are present)
- •c. Total bilirubin = 1.5 x ULN and direct bilirubin = ULN
- •d. International Normalized Ratio (INR) <1.5 (except if patient is on oral anticoagulation therapy)
- •e. Albumin = 3.0 g/dl
- •f. Calculated creatinine clearance (CrCl)=30 ml/min (according to the Cockcroft and Gault´s formula)
- •g. Creatine phosphokinase (CPK) = 2.5 x ULN
- •8. No prior or concurrent malignant disease unless in complete remission for more than three years, except for adequately treated in situ carcinoma of the cervix, basal or squamous skin cell carcinoma, or in situ transitional bladder cell carcinoma.
- •9. At least two weeks since last prior therapy (at least four weeks since completion of radiotherapy, if applicable) and recovery to grade = 1 from any adverse event (AE) derived from previous anticancer treatment (excluding alopecia and/or skin toxicity of any grade and asthenia and/or peripheral neuropathy, both grade = 2) according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE, version 4).
- •10. Women of childbearing potential must have a negative serum pregnancy test before study entry. Both women and men must agree to use a medically acceptable method of contraception throughout the treatment period and for six weeks after discontinuation of treatment.
- •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 22
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 21
排除标准
- •1. Prior treatment with PM01183.
- •2. Neuroendocrine differentiation or mucinous subtype on histology.
- •3. More than one prior systemic line of therapy for advanced disease.
- •4. Documented brain metastases or leptomeningeal disease involvement.
- •5. Concomitant diseases/conditions:
- •a. History, within last year, or presence of unstable angina, myocardial infarction, symptomatic congestive heart failure or asymptomatic left ventricular ejection fraction
- •(LVEF) =45% (assessed by multiple-gated acquisition scan [MUGA] or equivalent by ultrasound [US]) or clinically significant valvular heart disease.
- •b. Generalized edemas and/or ascites of grade =3
- •c. Immunocompromised patients, including those known to be infected by human immunodeficiency virus (HIV)
- •d. Chronically active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
- •e. Active uncontrolled infection
- •f. Myopathy or persistent CPK elevations > 2.5 x ULN in two different determinations performed one week apart
- •g. Limitation of the patient’s ability to comply with the treatment or to follow-up the protocol
- •h. Any other major illness that, in the Investigator’s judgment, will substantially increase the risk associated with the patient’s participation in this study
- •6. Uncontrolled ongoing deep venous thrombosis (DVT).
- •7. Men or women of childbearing potential who are not using an effective method of contraception as previously described; women who are pregnant or breast feeding.
- •8. Treatment with any investigational product within the period = 5 half-lives prior to the first infusion of PM01183.
研究者
相似试验
进行中（未招募）
1 期
Study of PM01183 in Patients with Metastatic Pancreatic CancerEUCTR2010-024292-30-ESPharma Mar, S.A. Sociedad Unipersonal45
进行中（未招募）
1 期
A Phase II Clinical Trial of PM01183 in BRCA 1/2-Associated or Unselected Metastatic Breast Cancer.BRCA1 / BRCA2 associated or unselected Metastatic Breast Cancer.MedDRA version: 14.1Level: LLTClassification code 10027475Term: Metastatic breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2011-006108-11-ESPharma Mar, S.A.117
进行中（未招募）
不适用
Study of PM01183 in platinum-resistant / refractory advanced ovarian cancer patients.Platinum-Resistant / Refractory Advanced Ovarian Cancer.MedDRA version: 14.0Level: PTClassification code 10033128Term: Ovarian cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2011-002172-16-ESPharma Mar S.A. Sociedad Unipersonal78
进行中（未招募）
1 期
Randomised study for second line treatment with nal-IRI and S1 in pancreatic cancer.pancreatic cancerEUCTR2017-004675-31-NLAcademic Medical Center120
进行中（未招募）
2 期
A randomized phase II study of second line treatment with liposomal irinotecan and S1 versus liposomal irinotecan and 5-fluorouracil in patients with metastatic pancreatic cancer who failed on first line gemcitabine-based chemotherapy2023-509463-24-01Amsterdam UMC146