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Phase 1/Phase 2
18 Years
Open (Enrolling)
Pancreatic Adenocarcinoma

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Trial Information

Inclusion Criteria:

1. Subject has provided signed informed consent. Fully understands requirements of the
trial and willing to comply with all trial visits and assessments.

2. Histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas
and availability of tumor sample.

3. Evidence of disease (not necessarily measurable disease). Complete tumor assessment
including chest X ray, CT scan of abdomen and other scans as necessary to document
all sites of disease performed within 28 days prior to trial entry/randomization.

4. Age ≥ 18 years.

5. Women of childbearing potential must have a negative blood pregnancy test at the
screening visit. For the purposes of this trial, women of childbearing potential is
defined as: "All female subjects after puberty unless they are post-menopausal for at
least two years, are surgically sterile or are sexually inactive."

6. Female subjects of childbearing potential and male subjects with female partners of
childbearing potential must be willing to avoid pregnancy by using an adequate method
of contraception for 2 weeks prior to screening, during and four weeks after the last
dose of trial medication. Adequate contraception is defined as two barrier methods,
or one barrier method with a spermicide, or intrauterine device. The use of hormonal
contraceptives should be avoided in female subjects of childbearing potential due to
a possible drug-drug interaction.

Exclusion Criteria:

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

2. Renal impairment as evidenced by serum creatinine > 1.5 x upper limit of normal
(ULN), and/or calculated creatinine clearance < 60 mL/min.

3. 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.

4. Serum calcium > 1 x ULN.

5. History of central nervous system (CNS) metastases, unless subject has been
previously treated for CNS metastases, is stable by CT scan without evidence of
cerebral edema, and has no requirements for corticosteroids or anticonvulsants.

6. Eastern Cooperative Oncology Group Performance Status (ECOG PS) greater than 1.

7. Significant cardiac conduction abnormalities, including QTc prolongation of > 480 ms
and/or pacemaker.

8. Retinal degenerative disease (hereditary retinal degeneration or age-related macular
degeneration), history of uveitis or history of retinal vein occlusion.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Safety Run-In Part: To determine the Maximum Tolerated Dose and the Recommended Phase II Dose of MSC1936369B when combined with gemcitabine in subjects with metastatic pancreatic adenocarcinoma for each of the two treatment regimens.

Outcome Time Frame:

1 Years

Safety Issue:


Principal Investigator

Bernard Laffranci 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:

November 2009

Completion Date:

August 2015

Related Keywords:

  • Pancreatic Adenocarcinoma
  • MEK inhibitor
  • cancer
  • pancreatic Adenocarcinoma
  • metastatic
  • chemo-naive
  • phase II
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous