Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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30 June 2019 |
Main ID: |
EUCTR2012-000675-16-GB |
Date of registration:
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10/08/2012 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Safety and efficacy of BEZ235 in patients with pancreatic neuroendocrine tumors (pNET)
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Scientific title:
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A multicenter, two stage, phase II study, evaluating the efficacy of oral BEZ235 plus best supportive care (BSC)
versus placebo plus BSC in the treatment of patients with advanced pancreatic neuroendocrine tumors (pNET) after failure of mTOR inhibitor therapy
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Date of first enrolment:
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19/09/2012 |
Target sample size:
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150 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-000675-16 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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Austria
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Belgium
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Germany
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Italy
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Korea, Republic of
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Netherlands
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Spain
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United Kingdom
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United States
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Contacts
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Name:
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Medical Collaboration Centre
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Address:
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Frimley Business Park
GU16 7SR
Frimley, Camberley, Surrey
United Kingdom |
Telephone:
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01276698370 |
Email:
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medinfo.uk@novartis.com |
Affiliation:
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Novartis Pharmaceuticals UK Ltd |
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Name:
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Medical Collaboration Centre
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Address:
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Frimley Business Park
GU16 7SR
Frimley, Camberley, Surrey
United Kingdom |
Telephone:
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01276698370 |
Email:
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medinfo.uk@novartis.com |
Affiliation:
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Novartis Pharmaceuticals UK Ltd |
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Key inclusion & exclusion criteria
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Inclusion criteria: -Unresectable or metastatic, histologically confirmed low or intermediate grade pancreatic neuroendocrine tumor with radiological evidence of disease progression since last treatment
-Refractory disease to treatment with mTOR inhibitor, Measurable disease per RECIST Version 1.1 using Computed Tomography (CT) or Magnetic Resonance Imaging (MRI)
-Prior or concurrent therapy with SSA is permitted;a stable dose at least 2 months prior to study start and must continue on the stable dose while receiving study treatment
-Other protocol defined inclusion/exclusion criteria may apply. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria: -Previous treatment with any PI3K or AKT inhibitor
-Discontinuation prior mTOR inhibitor therapy due to toxicity
-Poorly differentiated neuroendocrine carcinoma, highgrade neuroendocrine carcinoma, adenocarcinoid, goblet cell
carcinoid and small cell carcinoma
-Radiotherapy, or major surgery within 4 weeks prior to study treatment start
-Hepatic artery embolization or cryoablation/radiofrequency ablation of hepatic metastasis within 3 months of enrolment
-More than 3 prior systemic treatment regimens,
-Other protocol defined inclusion/exclusion criteria may apply
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Adult patient in advanced pancreatic neuroendocrine tumors
MedDRA version: 14.1
Level: LLT
Classification code 10068916
Term: Pancreatic neuroendocrine tumor metastatic
System Organ Class: 100000004864
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Therapeutic area: Diseases [C] - Cancer [C04]
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Intervention(s)
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Product Name: BEZ235 Product Code: BEZ235 Pharmaceutical Form: Powder for oral suspension CAS Number: 1028385-32-1 Current Sponsor code: BEZ235 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200- Pharmaceutical form of the placebo: Powder for oral suspension Route of administration of the placebo: Oral use
Product Name: BEZ235 Product Code: BEZ235 Pharmaceutical Form: Powder for oral suspension CAS Number: 1028385-32-1 Current Sponsor code: BEZ235 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 300- Pharmaceutical form of the placebo: Powder for oral suspension Route of administration of the placebo: Oral use
Product Name: BEZ235 Product Code: BEZ235 Pharmaceutical Form: Powder for oral suspension CAS Number: 1028385-32-1 Current Sponsor code: BEZ235 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Pharmaceutical form of the placebo: Powder for oral suspension Route of administration of the placebo: Oral use
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Primary Outcome(s)
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Timepoint(s) of evaluation of this end point: up to approx 18 months
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Main Objective: To estimate the efficacy of BEZ235 in adult patients with advanced (unresectable or metastatic) pNET (PFS)
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Primary end point(s): PFS rate at 16 weeks according to local radiological assessment per modified RECIST v1.1
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Secondary Objective: To assess the safety and tolerability of BEZ235 therapy To evaluate the efficacy of BEZ235 per modified RECIST v1.1 (Overall Response Rate, Disease Control Rate, Duration of Response )
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Secondary Outcome(s)
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Secondary end point(s): Frequency and severity of adverse events;other safety data as considered appropriate
Overall Response Rate, Disease Control Rate, Duration of Response )
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Timepoint(s) of evaluation of this end point: up to approx. 18 months for all secondary endpoint
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Secondary ID(s)
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2012-000675-16-AT
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CBEZ235F2201
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Source(s) of Monetary Support
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Novartis Pharma Services AG
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Ethics review
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Status: Approved
Approval date:
Contact:
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