A multinational, multicenter, open-label, controlled, randomised, parallel group study to evaluate the efficacy and safety of EMD 121974 and gemcitabine or gemcitabine alone in patients with advanced, unresectable pancreatic cancer

• Register: ISRCTN
• Last refreshed on: 13 January 2015
• Main ID: ISRCTN13413322
• Date of registration: 17/03/2006
• Prospective Registration: No
• Primary sponsor: Merck KGaA (Germany)
• Public title: A multinational, multicenter, open-label, controlled, randomised, parallel group study to evaluate the efficacy and safety of EMD 121974 and gemcitabine or gemcitabine alone in patients with advanced, unresectable pancreatic cancer
• Date of first enrolment: 15/10/1999
• Target sample size: 60
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN13413322
• Study type: Interventional
• Study design: Open label, controlled, randomized (Treatment)

Countries of recruitment

Germany

Contacts

• Name: Helmut Friess

Key inclusion & exclusion criteria

Inclusion criteria: 1. The patient must have provided written informed consent prior to any study-related procedure
2. The patient must be at least 18 years of age
3. The patient must be male or female without childbearing potential (i.e. post-menopausal or sterile)
4. The patient must suffer from histologically confirmed advanced unresectable pancreatic cancer with or without metastases
5. The patient must have at least one bidimensionally measurable or evaluable lesion
6. The life expectancy of the patient must be at least 12 weeks
7. The patient must have a Karnofsky performance score of = 70%
8. Outpatients as well as inpatients can be selected for this study
Exclusion criteria: 1. In the investigator?s opinion, if the patient is not able to comply with the protocol regulations
2. The patient is a pregnant or lactating female. Females with childbearing potential are generally excluded from the study.
3. The patient has received chemotherapy, and/or major surgery related to the pancreatic cancer prior to study entry. Palliative surgeries (e.g. for the placement of stents) or explorative laparotomies do not fall into this category.
4. The patient has received prior antiangiogenic therapy
5. The patient?s laboratory parameters lie within the following ranges: pre-treatment granulocytes <1500 /ml, haemoglobin <9 g/dl, platelet count <100,000 /ml, pre-treatment bilirubin >3 times the upper limit of normal, pre-treatment creatinine >2 times the upper limit of normal
6. The patient?s liver transaminases lie within the following ranges: serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamic pyruvic transaminase (SGPT) (alanine aminotransferase [ALT]) >5 times the upper limit of normal
7. The patient has had a second primary malignancy within the past five years except carcinoma in situ of the cervix or adequately treated basal cell carcinoma of the skin
8. The patient has a history of brain metastases. In case of suspected brain metastases, a computer tomography (CT) scan of the skull will be performed. This is not mandatory in asymptomatic patients.
9. The patient has had a major surgery within four weeks of study entry
10. The patient has a history of cerebrovascular accident (CVA) or transient ischemic attack (TIA)
11. The patient has had bypass surgery within six months of study entry, or has clinically significant cardiac or cardiovascular abnormalities (New York Heart Association [NYHA] III/IV) or unstable angina or arrhythmias (Lown class IV) requiring treatment
12. The patient has abnormal clotting disorders as defined by international normalized ratio (INR) >1.5, prothrombin time >18 seconds or activated partial thromboplastin time (APTT) >60 seconds, or patients on anticoagulant therapies. Migratory thrombophlebitis does not fall into this category.
13. The patient is suffering from severe diabetic angiopathy due to a long history of diabetes mellitus
14. The patient has had gastric or duodenal ulcers within six months of study entry, or is at risk of gastrointestinal ulceration due to a high consumption of non-steroidal anti-inflammatory drugs (NSAIDs)
15. The patient has a known active infection with Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV)
16. The patient is suffering from serious uncontrolled infections
17. The patient has a history of allergies against penicillin
18. The patient has a legal incapacity or a limited legal capacity
19. The patient is known for drug abuse or extensive chronic use of alcohol
20. The patient takes or is likely to need prohibited concomitant medication
21. The patient has participated in another clinical study within 30 days of study entry
22. Fertile men not willing to use contraception

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Unresectable pancreatic cancer
Cancer
Unresectable pancreatic cancer

Intervention(s)

EMD 121974 and gemcitabine versus gemcitabine alone

Primary Outcome(s)

Overall survival

Secondary Outcome(s)

1. Response
2. Progression
3. Safety
4. Quality of Life
5. Biomarkers

Secondary ID(s)

EMD 121974-004

Source(s) of Monetary Support

Merck KGaA (Germany)