MSC2015103B in Solid Tumors

Merck KGaA (EMD Serono)

Status and phase

Terminated

Phase 1

Conditions

Advanced Solid Tumor

Treatments

Drug: MSC2015103B

Study type

Interventional

Funder types

Industry

Identifiers

NCT01453387

EMR 200064-001

Details and patient eligibility

About

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 subjects once a day one day per week over a 21-day period or once a day three times per week over a 21-day period. The investigators would also like to find out how MSC2015103B is broken down by the body.

Additional purposes of the trial are to assess side effects of MSC2015103B and to find out whether MSC2015103B has anti-cancer effects. In addition, the investigators would like to explore pharmacokinetics.

Enrollment

28 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.