Metastatic Pancreatic Cancer MedDRA version: 14.1 Level: LLT Classification code 10007109 Term: Cancer of pancreas (excl head) metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: PM01183
Product Code: PM01183
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: lurbinectedin
CAS Number: 497871-47-3
Current Sponsor code: PM011
Sponsors
Pharma Mar, S.A. Sociedad Unipersonal
Eligibility
Sex/Gender
All
Inclusion 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 d. International Normalized Ratio (INR) =65 years) yes F.1.3.1 Number of subjects for this age range 21
Exclusion criteria
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the antitumor activity of PM01183 in terms of overall survival rate at 6 months (OS6) in patients with metastatic pancreatic cancer.;Secondary Objective: ? Progression-free survival (PFS) and progression-free survival rate at three (PFS3) and six months (PFS6). ? Response rate as per the Response Evaluation Criteria in Solid Tumors (RECIST v1.1) and duration of response. ? Tumor marker (CA19-9) evolution during treatment. ? Overall survival (OS) and overall survival rate at 12 months (OS12). ? Safety evaluation in this patient population. ? Pharmacokinetic (PK) analysis in this patient population. ? PK/PD (pharmacokinetic/pharmacodynamic) correlation, if applicable. ? To evaluate the pharmacogenomics (PGx) in prior available tumor samples of treated patients with PM01183 in order to assess potential biomarkers of sensitivity or resistance to PM01183.;Primary end point(s): Overall Survival at 6 months, defined as the percentage of patients who are alive six months after the first treatment dose.;Timepoint(s) of evaluation of this end point: Along the study durantion | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Overall response rate Duration of response Progression Free Survival at 3 and 6 months after the first infusion. Overall Survival at 12 months Treatment safety Pharmacokinetics and Pharmacokinetic/Pharmacodynamic correlation Pharmacogenomics ;Timepoint(s) of evaluation of this end point: Along the study durantion | — |
Countries
Spain, United Kingdom
Contacts
Public ContactClinical Trials
Pharma Mar, S.A. Sociedad Unipersonal
Outcome results
None listed