Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Clavis Pharma
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Histological or cytological confirmed advanced pancreatic cancer\*
You may not be if
Performance Status (ECOG) 0-2
Estimated life expectancy of at least 12 weeks
Age ≥ 18 years
Adequate haematological and biological functions:
* Neutrophils ≥ 1.5 x 109/L
* Platelets \> 100.0 x 109/L
* Hb ≥ 10 g/dL
* AST/ALT and alkaline phosphatase (ALP) ≤ 2.5 x institutional upper limit of normal (ULN), if liver metastases
* AST/ALT ≤ 5 x institutional ULN and ALP ≤ 4 x institutional ULN
* Bilirubin ≤ 1.5 times institutional ULN, if liver metastases ≤ 3 x institutional ULN
* Serum creatinine ≤ 1.5 times institutional ULN
Signed informed consent
Prior chemotherapy for metastatic disease
Symptomatic brain metastases
Participation in another therapeutic clinical study within 30 days of enrolment or during this clinical study
Requirement of concomitant treatment with a non-permitted medication, including high doses of vitamins and alternative drugs
History of allergic reactions to gemcitabine or egg
Presence of any serious concomitant systemic disorders incompatible with the clinical study (e.g. uncontrolled inter-current illness including ongoing or active infection)
Presence of any significant central nervous system or psychiatric disorder(s) that would hamper the patient's compliance
Pregnant or breastfeeding women
Absence of adequate contraception for both male and female fertile patients for the duration of the study; and also for three months after last treatment
Known positive status for HIV
Any reason why, in the investigator's opinion, the patient should not participate in the study.
Drug or alcohol abuse
Prior radical resection, but exploratory laparotomy as well palliative (e.g bypass) surgery are allowed
Clareo Health | A Study of CP-4126 in Patients With Advanced Pancreatic Cancer
