Status:
TERMINATED
MSC2015103B in Solid Tumors
Lead Sponsor:
EMD Serono
Conditions:
Advanced Solid Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The main purpose of this study is to test the experimental drug, MSC2015103B at different dose levels and on different treatment schedules, to see whether it is safe and can be tolerated when given to...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Pathologically confirmed solid tumor preferably, but not exclusively, including pancreatic, thyroid, colorectal, non-small cell lung, endometrial, renal, breast, ovarian carcinoma, or melanoma which is locally advanced or metastatic, and either refractory after standard therapy for the disease or for which no effective standard therapy is available
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of less than or equal to (\<=) 1
- Has read and understands the informed consent form and is willing and able to give informed consent. Fully understands requirements of and willing to comply with all trial visits and assessments
- Evidence of measurable disease at trial entry as per Response Evaluation Criteria In Solid Tumors (RECIST) v1.0.
- Willing to provide archival tissue samples for molecular analysis
- Other inclusion criteria as defined in protocol.
- Exclusion Criteria
- Bone marrow impairment as evidenced by hemoglobin less than (\<) 9.0 gram per deciliter (g/dL), neutrophil count \< 1.5 x 10\^9 per liter (/L), and/or platelets \<100 x 10\^9/L per liter (/L)
- Renal impairment as evidenced by serum creatinine greater than (\>) 1.5 x upper limit of normal (ULN) and/or calculated creatinine clearance \< 50 milliliter per minute (mL/min) (Cockcroft-Gault formula)
- Liver function and liver cell integrity abnormality as defined by total bilirubin \> 1.5 x ULN, or aspartate aminotransferase/alanine aminotransferase (AST/ALT) \> 2.5 x ULN, for subjects with liver involvement AST/ALT \> 5 x ULN. Subjects with albumin \< 2.5 g/dL are also excluded
- History of central nervous system (CNS) metastases.
- History of difficulty of swallowing, malabsorption, or other chronic gastrointestinal disease or conditions that may hamper compliance and/or absorption of the tested product.
- Chronic diarrhea that is \>= Grade 2 in severity
- Clinically significant cardiac conduction abnormalities
- A left ventricular ejection fraction of \< 45%
- A history of stroke or myocardial infarction within the past year
- A history of uveitis and scleritis
- Retinal pathology beyond normal age-related processes
- Evidence of a retinal vein occlusion on fluorescein angiogram or a history of retinal vein occlusion
- Subjects are also excluded if their ophthalmologist finds that their optic disc is at risk for a central retinal vein occlusion
- History of glaucoma
- Subjects requiring daily and/or chronic systemic steroids
- Pregnant or nursing females Other exclusion criteria as defined in protocol.
Exclusion
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT01453387
Start Date
September 1 2011
End Date
July 1 2013
Last Update
May 8 2017
Active Locations (3)
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1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
3
Karmanos Cancer Institute
Detroit, Michigan, United States