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Everolimus and LongActing Octreotide Trial in Polycystic Livers (ELATE)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01157858
First Posted: July 7, 2010
Last Update Posted: June 29, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Novartis
Information provided by (Responsible Party):
Joost Drenth, Radboud University
  Purpose
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 gives a bigger reduction of polycystic liver volume than octreotide monotherapy.

Condition Intervention Phase
Polycystic Liver Disease Drug: Everolimus Drug: Octreotide LAR Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Everolimus Added to Long Acting Octreotide as a Volume Reducing Treatment of Polycystic Livers

Resource links provided by NLM:


Further study details as provided by Joost Drenth, Radboud University:

Primary Outcome Measures:
  • Liver volume [ Time Frame: at baseline and at 12 months ]
    change of total liver volume in terms of percentage from baseline to 12 months as determined by CT


Secondary Outcome Measures:
  • Symptoms [ Time Frame: baseline and 12 months ]
    Change in symptoms, measured by GI-questionnaire

  • Quality of Life [ Time Frame: baseline and 12 months ]
    Change in quality of life, measured by EuroQoL-questionnaire

  • Responders [ Time Frame: baseline and 12 months ]
    Proportion of patients having any reduction in total liver volume after 12 months

  • Adverse events [ Time Frame: During 12 months of treatment ]
    Adverse events that occur in these 12 months


Enrollment: 44
Study Start Date: June 2010
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Everolimus + octreotide LAR
Octreotide LAR combined with everolimus
Drug: Everolimus
2.5 mg every day orally
Other Name: Afinitor
Drug: Octreotide LAR
40 mg every 28 days IM
Other Name: Sandostatine LAR
Active Comparator: Octreotide LAR
Octreotide LAR monotherapy
Drug: Octreotide LAR
40 mg every 28 days IM
Other Name: Sandostatine LAR

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 polycystic livers because of polycystic liver disease (PCLD).

We aim to include 44 patients affected by a polycystic liver either due to PCLD, 22 patients in the combination group and 22 patients in the mono therapy group.The duration of the trial will be 52 weeks. The treatment will be 48 weeks and the last control visit will take place four weeks after the treatment.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01157858


Locations
Netherlands
Department of Gastroenterology and Hepatology, Radboud University Nijmegen Medical Centre
Nijmegen, Netherlands, 6500 HB
Sponsors and Collaborators
Radboud University
Novartis
Investigators
Principal Investigator: Joost PH Drenth, MD, PhD Radboud University
Study Director: Melissa Chrispijn, MD Radboud University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Joost Drenth, MD, PhD, Radboud University
ClinicalTrials.gov Identifier: NCT01157858     History of Changes
Other Study ID Numbers: CSMS995 ANLIIT
First Submitted: July 6, 2010
First Posted: July 7, 2010
Last Update Posted: June 29, 2015
Last Verified: June 2015

Keywords provided by Joost Drenth, Radboud University:
liver cyst

Additional relevant MeSH terms:
Liver Diseases
Cysts
Digestive System Diseases
Neoplasms
Pathological Conditions, Anatomical
Everolimus
Sirolimus
Octreotide
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Gastrointestinal Agents
Antineoplastic Agents, Hormonal