EUCTR2010-024292-30-GB
Active, not recruiting
Not Applicable
A Phase II Study of PM01183 as Second-line Treatment in Patients with Metastatic Pancreatic Cancer
Pharma Mar, S.A. Sociedad Unipersonal0 sites43 target enrollmentMarch 10, 2011
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Pharma Mar, S.A. Sociedad Unipersonal
- Enrollment
- 43
- Status
- Active, not recruiting
- Last Updated
- 12 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Phase 1
Study of PM01183 in Patients with Metastatic Pancreatic CancerEUCTR2010-024292-30-ESPharma Mar, S.A. Sociedad Unipersonal45
Active, not recruiting
Phase 1
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)Therapeutic area: Diseases [C] - Cancer [C04]EUCTR2011-006108-11-ESPharma Mar, S.A.117
Active, not recruiting
Not Applicable
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)Therapeutic area: Diseases [C] - Cancer [C04]EUCTR2011-002172-16-ESPharma Mar S.A. Sociedad Unipersonal78
Active, not recruiting
Phase 1
Randomised study for second line treatment with nal-IRI and S1 in pancreatic cancer.pancreatic cancerTherapeutic area: Diseases [C] - Cancer [C04]EUCTR2017-004675-31-NLAcademic Medical Center120
Active, not recruiting
Phase 2
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