Study of efficacy and safety of the compound NGR-hTNF in patient with advanced malignant pleural mesothelioma

Phase 1

• Conditions: Advanced malignant pleural mesothelioma previuosly treated with a pemetrexed based chemotherapy regimen; MedDRA version: 14.0Level: PTClassification code 10035605Term: Pleural mesothelioma malignant advancedSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2009-016879-29-NL
• Lead Sponsor: MOLMED

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11-30
• Last Update Posted: 5 March 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 390

Inclusion Criteria

1.Age = 18 years
2. Histologically or cytological confirmed malignant pleural mesothelioma of any of the following subtype:
epithelial, sarcomatoid, mixed, or unknown
3. Prior treatment with no more than one sistemic pemetrexed-based chemotherapy regimen administered
for advanced or metastatic disease. Prior use of a biological agent in combination with a pemetrexed based
regimen and prior administration of intrapleural cytotoxic agents are allowed. Patients who have previously received anthracyclines should not receive doxorubicin.
4. ECOG Performance Status 0 - 2
5. Life expectancy of =12 weeks
6. Adequate baseline bone marrow, hepatic and renal function, defined as follows:
a. Neutrophils = 1.5 x 109/L; platelets = 100 x 109/L; hemoglobin = 9 g/dL
b. Bilirubin = 1.5 x ULN
c. AST and/or ALT = 2.5 x ULN in absence of liver metastasis or = 5 x ULN in presence of liver metastasis
d. Serum creatinine < 1.5 x ULN
7. Measurable or non-measurable disease according to MPM-modified RECIST criteria
8. Patients may have had prior therapy providing the following conditions are met:
a. Surgery: wash-out period of 14 days
b. Systemic anti-tumor and radiation therapy: wash-out period of 28 days
9. Patients must give written informed consent to participate in the study

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 390
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 390

Exclusion Criteria

1. Patients must not receive any other investigational agents while on study
2. Patients with myocardial infarction within the last six months, unstable angina, New York Heart association (NYHA) grade II or greater congestive heart failure, or serious cardiac arrhythmia requiring medication
3. Uncontrolled hypertension
4. QTc interval (congenital or acquired) > 450 ms
5. History or evidence upon physical examination of CNS disease unless adequately treated (e.g., primary brain tumor, any brain metastasis, seizure not controlled with standard medical therapy, or history of stroke)
6. Patients with active or uncontrolled systemic disease/infections or with serious illness or medical conditions, which is incompatible with the protocol
7. Known hypersensitivity/allergic reaction to human albumin preparations or to any of the excipients
8. Any psychological, familial, sociological or geographical condition potentially tampering compliance with the study protocol
9. Pregnancy or lactation.

Study & Design

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