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

Conditions: Advanced pleural mesothelioma
MedDRA version: 16.0Level: LLTClassification code 10035605Term: Pleural mesothelioma malignant advancedSystem Organ Class: 100000004864
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2008-005448-18-DE

Lead Sponsor: Morphotek, Inc.

Brief Summary: Not available

Detailed Description: Not available

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.Confirmed diagnosis of MPM with the following characteristics: •Unresectable disease (or otherwise not a candidate for curative surgery)
•Epithelial type or biphasic (mixed) type with low sarcomatous content.
4.Measurable disease at Screening
5.KPS 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 *= 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, these abnormalities 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 and for at least 8 weeks (ie, 5 half-lives of MORAb-009) following administration of the last dose of MORAb 009.
10.Willingness and ability 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 28
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 58

Exclusion Criteria

1.Mesothelioma of the sarcomatous type or disease located primarily in the peritoneum.
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 (e.g., 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 ECG (Note: Subjects with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal supraventricular tachycardia, 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 (e.g., interferons, immunoglobulin therapy, IL-1RA or systemic corticosteroids). Low-dose treatment with or 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.
12.Subjects who are Breast-feeding, pregnant, or likely to become pregnant during the clinical trial.
13.Subjects who are unable or unwilling to sign the trial informed consent form (ICF).