Status:
COMPLETED
Trial of MSC1936369B in Subjects With Solid Tumors
Lead Sponsor:
Merck KGaA, Darmstadt, Germany
Collaborating Sponsors:
Merck Serono S.A., Geneva
Conditions:
Solid Tumors
Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is a first in man trial with a primary objective being the determination of the Maximum Tolerated dose (MTD) and the dose-limiting toxicity (DLT) in several regimens of MEK inhibitor MSC1936369B ...
Eligibility Criteria
Inclusion
- Pathologically-confirmed solid tumor which is locally advanced or metastatic, and either refractory after standard therapy for the disease or for which no effective standard therapy is available. In the regimen 3, regimen 2 food-effect, and BID cohorts, the tumor type will be restricted to melanoma.
- Age greater than or equal to (\>=) 18 years
- Has read and understands the informed consent form and is willing and able to give informed consent. Fully understands requirements of the trial and willing to comply with all trial visits and assessments
Exclusion
- Bone marrow impairment as evidenced by Haemoglobin less than (\<) 9.0 gram per deciliter (g/dL), Neutrophil count \< 1.0\*10\^9/Liter, platelets \< 100\*10\^9/Liter
- Renal impairment as evidenced by serum creatinine \> 1.5\*upper limit normal (ULN), and/or calculated creatinine clearance \< 60 milliliter per minute (mL/min)
- Liver function abnormality as defined by total bilirubin \> 1.5\*ULN, or aspartate aminotransferase (AST)/alanine aminotransferase (ALT) \> 2.5\*ULN, for subjects with liver involvement AST/ALT \> 5\*ULN
- INR \> 1.5\*ULN
- Serum calcium \> 1\*ULN
- History of central nervous system (CNS) metastases, unless subject has been previously treated for CNS metastases, is stable by computer tomography (CT) scan without evidence of cerebral oedema, and has no requirements for corticosteroids or anticonvulsants
- History of difficulty swallowing, malabsorption or other chronic gastro-intestinal disease or conditions that may hamper compliance and/or absorption of the tested product
- Eastern Cooperative Oncology Group Performance status (ECOG PS) greater than (\>) 1
- Known human immunodeficiency virus (HIV) positivity, active hepatitis C, or active hepatitis B
Key Trial Info
Start Date :
December 31 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2016
Estimated Enrollment :
182 Patients enrolled
Trial Details
Trial ID
NCT00982865
Start Date
December 31 2007
End Date
April 30 2016
Last Update
October 23 2018
Active Locations (9)
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1
Westmead Hospital
Westmead, Australia
2
Jules Bordet Institute
Brussels, Belgium, B-1000
3
Ghent University Hospital
Ghent, Belgium
4
Institute Bergonié
Bordeaux, France