GR015: Randomised double-blind phase III study of NGR-hTNF plus best investigator's choice (BIC) versus placebo plus BIC in previously treated patients with advanced malignant pleural mesothelioma (MPM)

Phase 3

Completed

• Conditions: Pleural Tumor / advanced malignant pleural mesothelioma; 10027412

• Registration Number: NL-OMON37673
• Lead Sponsor: COMPANY IS INNOPHARMA S.R.L, ITALY

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 45

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;

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
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary variable:<br /><br>• Overall Survival (OS) is defined as the time from the<br /><br>date of randomization until the date of death due to any<br /><br>cause.</p><br>