Trial of gemcitabine with or without MSC1936369B in pancreas cancer

Conditions: First line treatment of metastatic pancreas CA with MSC1936369B in combination with gemcitabine and / or after progression under gemcitabine monotherapy second line treatment with MSC1936369B.
MedDRA version: 17.0Level: LLTClassification code 10033576Term: Pancreas carcinomaSystem Organ Class: 100000004864
MedDRA version: 17.0Level: LLTClassification code 10033577Term: Pancreas carcinoma recurrentSystem Organ Class: 100000004864
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2009-011992-61-BE

Lead Sponsor: Merck Serono S.A. - Geneva

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 86

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 adenocarcinoma of the pancreas with documented distant metastases 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, or are surgically sterile.”
6. Female subjects 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. Male subjects with female partner of childbearing potential must be willing o avoid pregnancy of their partner by using an adequate method of contraception for 2 weeks prior to screening, during and up to 6 months after the last dose trial medication. Adequate contraception is defined as two barrier methods, or one barrier method with a spermicide, or intrauterine device. The use of oral contraception is not recommended because of nausea and vomiting potentially induced by the study drugs.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 58
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 28

Exclusion Criteria

1. Bone marrow impairment as evidenced by hemoglobin < 9.0 g/dL, neutrophil count < 1.5 x 109/L, platelets < 100 x 109/L.
2. Renal impairment as evidenced by 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. History of difficulty swallowing, malabsorption or other chronic gastro-intestinal disease or conditions that may hamper compliance and/or absorption of the tested product.
7. Eastern Cooperative Oncology Group Performance Status (ECOG PS) greater than 1.
8. Known HIV positivity, active hepatitis C, active hepatitis B or signs and symptoms suggestive of transmissible spongiform encephalopathy, or family members who suffer(ed) from such.
9. Prior chemotherapy for metastatic disease, however prior chemotherapy will be accepted in the following situations:
• Subjects who received gemcitabine with radiation therapy as a radiosensitizer for locally advanced disease
• Subjects who completed chemotherapy (5-FU or gemcitabine) in adjuvant setting for resectable disease 6 months or more prior to the study entry
10. Extensive prior radiotherapy on more than 30% of bone marrow reserves, or prior bone marrow/stem cell transplantation. Prior radiation for local disease management is allowed if last fraction was completed at least 4 weeks prior to trial entry/randomization.
11. History of any other significant medical disease such as major gastric or small bowel surgery, recent drainage of significant volumes of ascites or pleural effusion or has other significant disease or a psychiatric condition that might impair the subjects well being or preclude full participation in the trial.
12. Significant cardiac conduction abnormalities, including QTc prolongation of >480 ms and/or pacemaker.
13. Pregnant or nursing female subject.
14. Retinal degenerative disease (Hereditary retinal degeneration or age-related macular degeneration), history of uveitis or history of retinal vein occlusion.
15. Known hypersensitivity to the MSC1936369B or gemcitabine.
16. Participation in another clinical trial within the past 28 days.
17. Has CPK level at baseline NCI CTCAE Grade =2 (i.e., > 2.5 x ULN), and/or has a previous history of myositis or rhabdomyolysis.