MSC2015103B in Solid Tumors

Therapuetic Areas:Oncology
Age Range:18 - Any
Start Date:September 2011
Contact:Gretchen Moufflet

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A Phase I Dose-Escalation First-In-Human Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of the Oral MEK Inhibitor MSC2015103B Administered With Two Different Treatment Schedules in Subjects With Advanced Solid Tumors

The main purpose of this study is to test the experimental drug, MSC2015103B (Pimasertib) 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.

Inclusion Criteria:

1. 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.

2. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of ≤ 1.

3. 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.

4. Evidence of measurable disease at trial entry as per Response Evaluation Criteria In
Solid Tumors (RECIST) v1.0.

5. Willing to provide archival tissue samples for molecular analysis.

Other inclusion criteria also apply.

Exclusion Criteria:

1. Bone marrow impairment as evidenced by hemoglobin < 9.0 g/dL, neutrophil count < 1.5
x 10^9/L, and/or platelets < 100 x 10^9/L.

2. Renal impairment as evidenced by serum creatinine > 1.5 x ULN (upper limit of normal)
and/or calculated creatinine clearance < 50 mL/min (Cockcroft-Gault formula).

3. 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.

4. History of central nervous system (CNS) metastases..

5. History of difficulty of swallowing, malabsorption, or other chronic gastrointestinal
disease or conditions that may hamper compliance and/or absorption of the tested

6. Chronic diarrhea that is ≥ Grade 2 in severity

7. Clinically significant cardiac conduction abnormalities.

8. A left ventricular ejection fraction of < 45%.

9. A history of stroke or myocardial infarction within the past year.

10. A history of uveitis and scleritis.

11. Retinal pathology beyond normal age-related processes.

12. 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.

13. History of glaucoma.

14. Subjects requiring daily and/or chronic systemic steroids.

15. Pregnant or nursing females.

Other exclusion criteria also apply.
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