Study of PM01183 as Treatment in Patients with Pancreatic Cancer

• Conditions: Metastatic Pancreatic Cancer; MedDRA version: 14.1Level: LLTClassification code 10007109Term: Cancer of pancreas (excl head) metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2010-024292-30-GB
• Lead Sponsor: Pharma Mar, S.A. Sociedad Unipersonal

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03-10
• Last Update Posted: 7 April 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 43

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) <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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified