An Open-Label Clinical Trial of MORAb-009 in Combination With Pemetrexed and Cisplatin in Subjects With Mesothelioma

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 86

Inclusion Criteria

1.Female or male and = 18 years of age.
2.Life expectancy of at least 3 months.
3.Histologically confirmed unresectable MPM (epithelial or mixed subtypes of at least 75% epithelial content).
4.Measurable disease at Screening.
5.Karnofsky performance status of = 70% at Screening (Appendix 3).
6.Other significant medical conditions must be well-controlled and stable in the opinion of the investigator for at least 30 days prior to Day 1.
7.Laboratory and clinical results within 2 weeks prior to Day 1 must be as follows:
Absolute neutrophil count (ANC)= 1.5 x 109/L
Platelet count= 100 x 109/L
Hemoglobin= 9 g/dL
Serum bilirubin= 1.5 x upper limit of normal (ULN)
Aspartate transaminase (AST)*= 2.5 x ULN
Alanine transaminase (ALT)*= 2.5 x ULN
Alkaline phosphatase (ALK-P)*= 3 x ULN
Serum creatinine= 2.0 mg/dL
* Subjects with liver function abnormalities greater than the ULN specified above are eligible only if, in the opinion of the investigator, they are due to disease obstruction of the bile ducts or metastatic disease. Stenting to reduce liver functions to qualifying levels is permitted.
8.Calculated serum creatinine clearance = 60 mL/min using the Cockroft Gault equation (Appendix 7).
9.Female subjects of childbearing potential and all male subjects must be surgically sterile or consent to use a medically acceptable method of contraception throughout the trial.
10.Willing and able to provide 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

Exclusion Criteria

1.Sarcomatous subtype of mesothelioma.
2.Prior systemic therapy or radiotherapy for mesothelioma; prior treatment with local radiotherapy for symptom control (ie, non-curative intent) is permitted.
3.Known central nervous system (CNS) tumor involvement.
4.Evidence of other active malignancy requiring treatment.
5.Clinically significant heart disease (eg, congestive heart failure of New York Heart Association Class 3 or 4 angina not well controlled by medication, or myocardial infarction within 6 months).
6.Active viral hepatitis or symptomatic human immunodeficiency virus (HIV) infection.
7.Clinically significant arrhythmias demonstrated on electrocardiogram (ECG) (Note: Subjects with chronic atrial arrhythmia, ie, atrial fibrillation or paroxysmal supraventricular tachycardia [SVT], are eligible).
8.Active, serious systemic disease, including active bacterial or fungal infection.
9.Treatment within 3 months of the start of the trial with other immunomodulatory therapy (eg, interferons, immunoglobulin therapy, IL-1RA or systemic corticosteroids). Short term use of systemic corticosteroids, topical or intra-articular steroids is acceptable, subject to the judgment of the investigator.
10.Known hypersensitivity to any of the following: monoclonal antibodies or biologic therapy, pemetrexed or ingredients used in the formulation of pemetrexed, cisplatin or other platinum containing compounds.
11.Known allergy or hypersensitivity to oral and/or IV contrast agents, as required for the imaging studies included in this protocol (Section 6.10).
12.Breast-feeding, pregnant, or likely to become pregnant during the clinical trial.
13.Unwillingness or inability to sign the trial informed consent form (ICF).

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Related Trials