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A Multicenter, Open Label, Phase I Trial of the MEK Inhibitor MSC1936369B Given Orally to Subjects With Solid Tumours

Phase 1
18 Years
Open (Enrolling)
Solid Tumors, Cancer

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Trial Information

A Multicenter, Open Label, Phase I Trial of the MEK Inhibitor MSC1936369B Given Orally to Subjects With Solid Tumours

Inclusion Criteria:

- Pathologically-confirmed solid tumour 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 tumour type will be restricted to melanoma.

- Age ≥ 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 Criteria:

- Bone marrow impairment as evidenced by Haemoglobin < 9.0 g/dL, Neutrophil count < 1.0
x 109/l, platelets < 100 x 109/l.

- Renal impairment as evidenced by serum creatinine > 1.5 x ULN, and/or calculated
creatinine clearance < 60 ml/min.

- Liver function abnormality as defined by total bilirubin > 1.5 x ULN, or AST/ALT >
2.5 x ULN, for subjects with liver involvement AST/ALT > 5 x ULN.

- INR > 1.5 x ULN.

- Serum calcium > 1 x ULN.

- History of CNS metastases, unless subject has been previously treated for CNS
metastases, is stable by 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

- Eastern Cooperative Oncology Group Performance status (ECOG PS) greater than 1.

- Known HIV positivity, active hepatitis C, or active hepatitis B.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The number and proportion of subjects experiencing at least a Dose-Limiting Toxicity (DLT) over the first cycle - day 1 to 21 for each regimen separately.

Outcome Time Frame:

21 days

Safety Issue:


Principal Investigator

Narmyn Rejeb, MD

Investigator Role:

Study Director

Investigator Affiliation:

Merck Serono S.A., Geneva


France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:




Start Date:

January 2008

Completion Date:

February 2013

Related Keywords:

  • Solid Tumors
  • Cancer
  • MEK inhibitor
  • Cancer
  • Solid tumours
  • Neoplasms