Phase Ib Study of Anetumab Ravtansine in Combination With Pemetrexed and Cisplatin in Mesothelin-… (NCT02639091) | Clinical Trial Compass
CompletedPhase 1
Phase Ib Study of Anetumab Ravtansine in Combination With Pemetrexed and Cisplatin in Mesothelin-expressing Solid Tumors
United States, Italy36 participantsStarted 2016-02-03
Plain-language summary
Determine the safety, tolerability and maximum tolerated dose of anetumab ravtansine (BAY 94-9343) in combination with pemetrexed 500 mg/m2 and cisplatin 75 mg/m2 in subjects with mesothelin-expressing predominantly epithelial mesothelioma or nonsquamous non-small-cell lung cancer.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Subjects may be male or female, and must be aged =/\>18 years on the date of signing the informed consent form.
* Subjects must have histologically confirmed, unresectable, locally advanced or metastatic pleural or peritoneal predominantly (\>50% of tumor component) epithelial mesothelioma or nonsquamous non-small-cell lung cancer (NSCLC). Both chemotherapy-naive and previously treated subjects will be eligible; however, newly diagnosed NSCLC subjects eligible for FDA-approved therapies should have received the same before enrollment (e.g. subjects with epidermal growth factor receptor \[EGFR\]-mutated and anaplastic lymphoma kinase \[ALK\]-translocated NSCLC should have received FDA-approved targeted therapies).
* Subjects must have at least 1 measurable or evaluable tumor lesion according to RECIST 1.1 (for nonsquamous NSCLC) or mRECIST (for epithelial pleural mesothelioma). Subjects with resected primary tumors who have documented metastases are eligible.
* Subjects must have a life expectancy of at least 12 weeks.
* Subjects must have ECOG (Eastern Cooperative Oncology Group performance Status of 0 or 1
* Subjects must have adequate bone marrow, liver, kidney, and coagulation functions.
Exclusion Criteria:
* Subjects who have a previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study, or any previous cancer curatively treated \>3 years before the start of study Treatment.
* Subjects …
What they're measuring
1
Maximum tolerated dose (MTD)
Timeframe: Up to 2 years
2
Number of subjects with adverse events and serious adverse events as a measure of safety and tolerability