Clinical trial · Interventional
An Efficacy Study of MORAb-009 (Amatuximab) in Subjects With Pleural Mesothelioma
An Open-Label Clinical Trial of MORAb-009 in Combination With Pemetrexed and Cisplatin in Subjects With Mesothelioma
NCT00738582CI-TRIAL-00061002AmatuximabcompletedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This research is being done to find out if pemetrexed and cisplatin work better when given together with an experimental drug called MORAb-009 in patients with malignant pleural mesothelioma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Pleural Mesothelioma | Pleural Malignant Mesothelioma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| MORAb-009 (Amatuximab) | Drug | — | UNRESOLVED |
| Pemetrexed | Drug | Pemetrexed | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Open Label
- description
- Pemetrexed, Cisplatin and MORAb-009 (Amatuximab)
- interventionNames
- Drug: MORAb-009 (Amatuximab)
- Drug: Pemetrexed
- Drug: Cisplatin
Primary outcomes (1)
- measure
- Number of Participants With Progression Free Survival (PFS) Responders and Non-responders at Month 6
- timeFrame
- Month 6
- description
- Number of participants with PFS responders and non-responders at Month 6 was reported. PFS was defined as the time from the date of the first dose of amatuximab to the date of disease progression or death due to any cause, as determined by independent radiologist based on the modified Response Evaluation Criteria in Solid Tumors (RECIST) utilizing the total tumor measurement (performed by computerized tomography (CT)/magnetic resonance imaging (MRI)) which includes the pleural unidimensional measure plus the total of the target lesion(s) measurement. A "response", in terms of PFS, was defined to be at least a 6-month stabilization of disease. Progressive disease (PD) as measured by Modified RECIST was defined as an increase of at least 20 percent (%) in the total tumor measurement over the nadir measurement, or the appearance of one or more new lesions.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Primary Inclusion Criteria: * Confirmed diagnosis of malignant pleural mesothelioma (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. * Measurable disease at Screening by computed tomography (CT)(or magnetic resonance imaging \[MRI\]). * KPS of greater than or equal to 70% at Screening. * Life expectancy of at least 3 months Primary Exclusion Criteria: * Sarcomatous type of mesothelioma * Prior systemic therapy or radiotherapy for MPM; local radiotherapy for symptom control (ie, non-curative intent) is permitted. * Confirmed presence of CNS tumor involvement. * Evidence of other active malignancy requiring treatment.
References
Publications (0)
Data not yet available
No reference posted for this study.