Everolimus and LongActing Octreotide Trial in Polycystic Livers (ELATE)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Radboud University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Novartis
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT01157858
First received: July 6, 2010
Last updated: NA
Last verified: July 2010
History: No changes posted
  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: 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 Radboud University:

Primary Outcome Measures:
  • Liver volume [ Time Frame: at baseline and at 12 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    Change in symptoms, measured by GI-questionnaire

  • Quality of Life [ Time Frame: baseline and 12 months ] [ Designated as safety issue: No ]
    Change in quality of life, measured by EuroQoL-questionnaire

  • Responders [ Time Frame: baseline and 12 months ] [ Designated as safety issue: No ]
    Proportion of patients having any reduction in total liver volume after 12 months

  • Adverse events [ Time Frame: During 12 months of treatment ] [ Designated as safety issue: Yes ]
    Adverse events that occur in these 12 months


Estimated Enrollment: 44
Study Start Date: June 2010
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: December 2011 (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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01157858

Contacts
Contact: Melissa Chrispijn, MD +3124 3614760 M.Chrispijn@mdl.umcn.nl
Contact: Joost PH Drenth, MD, PhD +3124 3614760 joostphdrenth@cs.com

Locations
Netherlands
Department of Gastroenterology and Hepatology, Radboud University Nijmegen Medical Centre Recruiting
Nijmegen, Netherlands, 6500 HB
Contact: Melissa Chrispijn, MD    +3124 3614760    M.Chrispijn@mdl.umcn.nl   
Contact: Joost PH Drenth, MD, PhD    +3124 3614760    joostphdrenth@cs.com   
Principal Investigator: Joost PH Drenth, MD, PhD         
Sub-Investigator: Melissa Chrispijn, MD         
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

No publications provided by Radboud University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Joost P.H. Drenth, MD, PhD, Radboud University Nijmegen Medical Centre
ClinicalTrials.gov Identifier: NCT01157858     History of Changes
Other Study ID Numbers: CSMS995 ANLIIT
Study First Received: July 6, 2010
Last Updated: July 6, 2010
Health Authority: Netherlands: Medical Ethics Review Committee (METC)
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Radboud University:
liver cyst

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

ClinicalTrials.gov processed this record on July 10, 2014