A Phase I Open-label Uncontrolled Multicenter Dose-escalation Study of M3541 in Combination with Palliative Radiotherapy in Subjects with Solid Tumors
Greg Durm, MD
Primary Investigator
Overview
The main purpose of this research study is to determine the maximum tolerated dose (MTD) and the recommended phase II dose for the study drug in combination with fractionated palliative radiotherapy (RT) for tumors.
Description
The purpose of this study is to determine the maximum tolerated dose (MTD) and the recommended phase II dose for the study drug in comnbination with fractionated palliative radiotherapy (RT) for tumors.
Eligibility
You may be eligible for this study if you meet the following criteria:
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Conditions:
Solid Tumor,Cancer,solid tumors
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Age: Between 18 Years - 100 Years
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Gender: All
Inclusion Criteria
Must have solid tumors with malignant lesions in the thorax, abdominal cavity, head and neck region, or extremities (any histology) likely to benefit from palliative radiotherapy
Life expectancy greater than or equal to 3 months
Adequate hematological function
Adequate hepatic function
Adequate liver function
Exclusion Criteria
Use of other anticancer therapy within 15 days before the first dose of M3541 administration
Prior RT to the same region that would be irradiated in this study
At increased risk for radiation toxicities, such as known collagen vascular disease or other inherited radiation hypersensitivity syndromes
Surgical intervention within 28 day prior to the first dose of M3541 administration
Significant cardiac conduction abnormalities
Hypertension uncontrolled by medicine
Known central nervous system metastases causing clinical symptoms or metastases that require therapeutic intervention
Known human immunodeficiency virus (HIV) positivity, known clinically significant history of liver disease, including active viral or other hepatitis
Ongoing active infection or treatment with live or live attenuated vaccine within 30 days of dosing
Active difficulty swallowing, malabsorption or other chronic gastrointestinal disease or conditions that may hamper compliance and/or absorption of M3541
Known hypersensitivity or allergic reaction to the study treatments or to 1 or more of the excipients used
Pregnant or breast-feeding
