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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. |
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Register:
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EUCTR |
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Last refreshed on:
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4 January 2022 |
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Main ID: |
EUCTR2011-003822-29-BE |
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Date of registration:
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07/03/2012 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Phase 2 Study in Patients with Pancreatic Cancer
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Scientific title:
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A Randomized Phase 2 Placebo-Controlled Study of LY2495655 in Patients with Advanced or Metastatic Pancreatic Cancer Receiving Chemotherapy |
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Date of first enrolment:
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19/03/2012 |
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Target sample size:
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120 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-003822-29 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
Number of treatment arms in the trial: 3
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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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Belgium
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Canada
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Israel
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Norway
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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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Clinical Trial Information
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Address:
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Telephone:
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Email:
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EU_Lilly_Clinical_Trials@lilly.com |
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Affiliation:
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Eli Lilly |
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Name:
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Clinical Trial Information
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Address:
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Telephone:
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Email:
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EU_Lilly_Clinical_Trials@lilly.com |
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Affiliation:
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Eli Lilly |
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Key inclusion & exclusion criteria
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Inclusion criteria:
• Patients with unresectable or metastatic pancreas cancer
• ECOG Performance status = 2
• Adequate organ function
• Have an estimated life expectancy of at least 12 weeks and in the judgment of the investigator, will be able to complete at least 2 cycles of treatment
• Ability to perform the indicated functional performance measures at baseline.
• Females with child bearing potential must have a negative serum pregnancy test = 7 days prior to the first dose of study drug.
• Males and females with reproductive potential must agree to use medically approved contraceptive precautions during the trial and for 3 months after discontinuation from study therapy.
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 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 95
Exclusion criteria:
• Have received prior systemic therapy for unresectable/metastatic pancreas cancer.
• Have underlying muscle disease or history of muscle disease
• Have evidence or recent history of significant psychiatric disease such as dementia/Alzheimer’s, schizophrenia, or bipolar disorder.
• Currently taking medications that are considered both muscle building and performance enhancing (for example, androgen therapies, or anabolic steroids)
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Muscle wasting and weakness associated with cancer of the pancreas that is locally advanced or metastatic
MedDRA version: 14.1
Level: LLT
Classification code 10064015
Term: Cancer cachexia
System Organ Class: 10027433 - Metabolism and nutrition disorders
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Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]
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Intervention(s)
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Product Name: LY2495655 for Injection
Product Code: LY2495655
Pharmaceutical Form: Lyophilisate for solution for infusion
Current Sponsor code: LY2495655
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 53-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use
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Primary Outcome(s)
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Timepoint(s) of evaluation of this end point: 6 months after completion of enrollment
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Primary end point(s): Overall survival
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Secondary Objective: • To establish the safety of LY2495655 in combination with gemcitabine-based therapy in first-line treatment of pancreatic cancer
• To establish the safety of LY2495655 in combination with select post first-line treatment(s) for pancreatic cancer
• To compare the three treatment arms with respect to tumor response and time to event measures
• To explore changes in body composition (muscle and fat) and muscle volume as measured by DXA scan and CT scan over the course of the study
• To explore the effect of LY2495655 versus placebo on the following:
o Functional performance measures
o Patient reported outcomes
o Cardiac and pulmonary function
o Nutritional status
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Main Objective: To determine if LY2495655 administered in combination with chemotherapy improves overall survival (OS), compared to chemotherapy in combination with placebo in patients with Stage II-IV unresectable pancreatic cancer
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Secondary Outcome(s)
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Timepoint(s) of evaluation of this end point: 6 months after completion of enrollment
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Secondary end point(s): Response rate, duration of response and progression free survival measured per RECIST (v 1.1)
Body composition and muscle volume
Functional Performance measures
Pulmonary Function
ADL and Instrumental ADLs (IADLs)
Nutritional assessment
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Secondary ID(s)
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I1Q-MC-JDDG(b)
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 19/03/2012
Contact:
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