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Phase Ib Study of Anetumab Ravtansine in Combination With Pemetrexed and Cisplatin in Mesothelin-expressing Solid Tumors

Brief 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.

Tracking Information
First Received DateNovember 30, 2015
Last Changed DateNovember 29, 2017
Start DateFebruary 3, 2016
Anticipated Primary Completion DateJuly 18, 2018
Primary Outcome Measures

Maximum tolerated dose (MTD) [Time Frame: Up to 2 years]

Number of subjects with adverse events and serious adverse events as a measure of safety and tolerability [Time Frame: Up to 2 years]

Secondary Outcome Measures

Plasma concentrations of anetumab ravtansine (BAY 94-9343), pemetrexed and cisplatin [Time Frame: - BAY 94-9343: C1D1,D2,D3,D8,D15, C2D1, C3D1,D2,D3,D8,D15, C4D1, C6D1 and subsequent cycles every 3rd cycle up to 2 years or until discontinuation of study treatment, whichever comes first - Pemetrexed: C1D1, D2, D3 - Cisplatin: C1D1, D2, D3]

Tumor response evaluation following mRECIST criteria to determine the number of patients with CR, PR, SD or PD [Time Frame: Baseline, every 8 weeks up to cycle 12; then every 12 weeks from cycle 13 up to 2 years, or until discontinuation of study treatment, whichever comes first]

Number of patients with a positive titer of anti-drug antibodies [Time Frame: Day1 of C1, C3, C6 and subsequent cycles every 3rd cycle up to 2 years or until discontinuation of study treatment, whichever comes first]

Descriptive Information
PhasePhase 1
Study TypeInterventional
Condition
  • Medical Oncology
Intervention
  • Drug: BAY 94-9343
  • Drug: Pemetrexed
  • Drug: Cisplatin
Study Arms / Comparison Groups1 / 0
Recruitment Information
Recruitment StatusRecruiting
Anticipated Enrollment30
GenderAll
Ages18 Years - N/A
Accepts Healthy VolunteersNo
Contact Bayer Clinical Trials Contact
Email: clinical-trials-contact@bayer.com
Eligibility Criteria

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 who have a history or current evidence of bleeding disorder, i.e. any hemorrhage / bleeding event of CTCAE (Common Terminology Criteria for Adverse Events) Grade ≥2 within 4 weeks before the start of study Treatment.

- Subjects who have new or progressive brain or meningeal or spinal metastases.

- Subjects who have a history or current evidence of uncontrolled cardiovascular disease i.e. NYHA (New York Heart Association) Class III or IV.

- Subjects who have a history or current evidence of uncontrolled hypertension defined as systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg at screening despite optimal medical management.

- Subjects who have a history or current evidence of malignant biliary obstruction requiring biliary stent.

- Subjects who have had solid organ or bone marrow Transplantation.

- Subjects who have a history of hypersensitivity to any of the study drugs or their excipients, or a history of severe hypersensitivity to any other Antigen.

- Subjects who have a history of human immunodeficiency virus (HIV) infection or subjects who have an active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection requiring treatment.

- Subjects who have an active clinically serious infection of CTCAE Grade ≥2 or non-healing wound unrelated to the primary Tumor.

- Subjects who have received systemic cancer therapy, radiotherapy, investigational drug treatment outside of this study within 4 weeks before the start of study treatment, granulocyte colony stimulating factors, (G-CSF) or granulocyte macrophage-stimulating factors (GM-CSF), erythropoietin-stimulating agents within 3 weeks before the start of general screening, drugs with known renal toxicity and strong cytochrome P450 3A4 (CYP3A4) inhibitors or strong CYP3A4 inducers within 2 weeks before the treatment.

- Subjects who have started oral or parenteral anticoagulation therapy within 2 weeks before the start of anetumab ravtansine until end of treatment visit.

Administrative Information
NCTIDNCT02639091
Responsible Party,
SponsorBayer
Verification DateNovember 2017
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