Phase 3
N=400
NGR015: Study in Second Line for Patient With Advanced Malignant Pleural Mesothelioma Pretreated With Pemetrexed
Malignant Pleural Mesothelioma
Bottom Line
View on ClinicalTrials.gov: NCT01098266 ↗Enrolled (actual)
400
Serious AEs
28.5%
Results posted
Sep 2019
Primary outcome: Primary: Overall Survival (OS) — 8.5; 8.0 months — p=0.58
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- NGR-hTNF plus Best Investigator's Choice (BIC) (Drug); Placebo plus Best Investigator's Choice (BIC) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AGC Biologics S.p.A.
- Primary completion
- Apr 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival (OS) |
8.5; 8.0 | 0.58 |
| SECONDARY Progression-Free Survival (PFS) |
3.4; 3.0 | 0.65 |
| SECONDARY Disease Control Rate (DCR) |
114; 109; 3; 6; 111; 103 | 0.62 |
| SECONDARY Number of Partecipants With Disease Control for ≥ 6 Months |
84; 76 | — |
| SECONDARY Number of Partecipants With Adverse Events |
191; 185; 102; 86; 22; 19 | — |
| SECONDARY Time to LCSS Symptomatic Progression |
3.2; 3.0 | 0.5806 |
| SECONDARY Evaluation of Medical Care Utilization in the Two Treatment Arms |
0; 2; 5; 2; 7; 10 | — |
Summary
The main objective of the trial is to document the efficacy of NGR-hTNF administered at low dose weekly in advanced Malignant Pleural Mesothelioma patients previously treated with a pemetrexed-based chemotherapy regimen.
Eligibility Criteria
Inclusion Criteria
- Age ≥ 18 years
- Histologically or cytological confirmed malignant pleural mesothelioma of any of the following subtype: epithelial, sarcomatoid, mixed, or unknown
- Prior treatment with no more than one systemic 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
- ECOG Performance Status 0 - 2
- Life expectancy of ≥ 12 weeks
- Adequate baseline bone marrow, hepatic and renal function, defined as follows:
- Neutrophils ≥ 1.5 x 109/L; platelets ≥ 100 x 109/L; hemoglobin ≥ 9 g/dL
- Bilirubin ≤ 1.5 x ULN
- AST and/or ALT ≤ 2.5 x ULN in absence of liver metastasis or ≤ 5 x ULN in presence of liver metastasis
- Serum creatinine 450 ms
- 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)
- Patients with active or uncontrolled systemic disease/infections or with serious illness or medical conditions, which is incompatible with the protocol
- Known hypersensitivity/allergic reaction to human albumin preparations or to any of the excipients
- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol
- Pregnancy or lactation
Data sourced from ClinicalTrials.gov (NCT01098266). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.