Status:
COMPLETED
Everolimus and LongActing Octreotide Trial in Polycystic Livers
Lead Sponsor:
Radboud University Medical Center
Collaborating Sponsors:
Novartis
Conditions:
Polycystic Liver Disease
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
The aim of this study is to reduce polycystic liver volume by treating with octreotide, whether or not combined with everolimus; to assess whether combination therapy of everolimus and octreotide give...
Detailed Description
This is a single center randomized, open-label, parallel study comparing the safety and efficacy of everolimus-octreotide LAR treatment to monotherapy octreotide LAR in adult symptomatic patients with...
Eligibility Criteria
Inclusion
- 18 \< age ≤ 70 years
- Polycystic liver disease (PCLD), defined as ≥ 20 liver cysts
- Total liver volume must be at least 2500 mL
- Symptomatic defined as ECOG-PS ≥ 1 (see fig 3.1)38, and having at least three out of ten PCLD symptoms:
- Abdominal pain
- Abdominal distension
- Abdominal fullness
- Dyspnea
- Early satiety
- Back pain
- Nausea/vomiting
- Anorexia
- Weight loss
- Jaundice
- Informed consent, patients are willing and able to comply with the study drug regimen and all other study requirements
Exclusion
- ADPKD patients
- Use of oral anticonceptives or estrogen supplementation
- Females who are pregnant or breast-feeding or patients of reproductive potential not employing an effective method of birth control. Women of childbearing potential must have a negative serum pregnancy test within 48 hours prior to the administration of study medication.
- Intervention (aspiration or surgical intervention) within three months before baseline
- Treatment with somatostatin analogues within three months before baseline
- Patients with a kidney transplant
- History or other evidence of chronic pulmonary disease associated with functional limitation
- History of severe cardiac disease (eg, NYHA Functional Class III or IV, myocardial infarction within 6 months, ventricular tachyarrhythmias requiring ongoing treatment, unstable angina or other significant cardiovascular diseases). In addition, patients with documented or presumed coronary artery disease or cerebrovascular disease should not be enrolled.
- History or other evidence of severe illness or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study
- Symptomatic gallstones (octreotide decreases gall bladder volume)
- Hypercholesterolemia (fasting cholesterol \> 8 mmol/l) or hypertriglyceridaemia (\> 5 mmol/l) not controlled by lipid lowering therapy
- Granulocytopenia (white blood cell \< 3,000/mm3) or thrombocytopenia (platelets \< 100,000/mm3)
- Infection with hepatitis B, hepatitis C, HIV, TBC (in medical history)
- Mental illness that interferes with the patient ability to comply with the protocol
- Drug or alcohol abuse within one year of baseline
- Co-medication with strong inhibitor of CYP3A4 and or P-gp like voriconazole, ketoconazole, diltiazem, verapamil, erythromycin or with a strong CYP3A4 and or P-gp inductor like rifampicin
- Known hypersensitivity to everolimus or one of its excipients
- Enrolment in another clinical trial of an investigational agent while participating in this study
- Moderate or severe reaction on contrast in medical history
- Treatment with I131 during the course of the trial
- Use of metformin
- Morbus Kahler or Morbus Waldenstrom with excretion of light chains in urine in medical history
- Kidney dysfunction (MDRD-GFR \< 60 ml/min/1.73m2 and ECC \< 60 ml/min, calculated by the Cockcroft-Gault formula); in case of decreased body muscle mass, exact ECC is measured using serum and urine creatinine
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT01157858
Start Date
June 1 2010
End Date
July 1 2012
Last Update
June 29 2015
Active Locations (1)
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1
Department of Gastroenterology and Hepatology, Radboud University Nijmegen Medical Centre
Nijmegen, Netherlands, 6500 HB