A Phase 2 Study of LY2495655 in Participants With Pancreatic Cancer
- Conditions
- Pancreatic Cancer
- Interventions
- Registration Number
- NCT01505530
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
This phase 2 study is a multicenter, randomized, double-blind, placebo-controlled trial in participants with locally advanced/inoperable or metastatic pancreatic cancer, and will investigate 2 different doses of LY2495655 in combination with standard of care chemotherapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 125
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 100 mg LY2495655 + chemotherapy Standard of Care Chemotherapy 100 mg LY2495655 intravenous (IV) in combination with standard of care chemotherapy (investigator's choice) Placebo + chemotherapy Placebo Placebo in combination with standard of care chemotherapy (investigator's choice) 300 mg LY2495655 + chemotherapy Standard of Care Chemotherapy 300 mg LY2495655 intravenous (IV) in combination with standard of care chemotherapy (investigator's choice) Placebo + chemotherapy Standard of Care Chemotherapy Placebo in combination with standard of care chemotherapy (investigator's choice) 300 mg LY2495655 + chemotherapy LY2495655 300 mg LY2495655 intravenous (IV) in combination with standard of care chemotherapy (investigator's choice) 100 mg LY2495655 + chemotherapy LY2495655 100 mg LY2495655 intravenous (IV) in combination with standard of care chemotherapy (investigator's choice)
- Primary Outcome Measures
Name Time Method Overall Survival (OS) Baseline to Death from Any Cause (Up to 23 months) Overall survival (OS) duration was measured from the date of randomization to the date of death from any cause.
- Secondary Outcome Measures
Name Time Method Duration of Response First CR or PR to Disease Progression (Up to 11 months) The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause. Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.1) criteria. Complete Response (CR) was defined as the disappearance of all non-nodal target lesions, with the short axes of any target lymph nodes reduced to \<10 millimeters (mm). Partial Response (PR) was defined as having at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph nodes), taking as reference the baseline sum diameter.
Change in Physical Performance Measures Using Hand Grip Strength Baseline, Cycles 2, 4, 6, 8 and 10; Day 1 Hand grip strength (HGS) of the non-dominant hand measured using a hand dynamometer.
Change in Lean Body Mass Baseline, Cycles 3, 5, 7, 9 and 11; Day 1 Change in lean body mass was assessed using dual-energy x-ray absorptiometry (DXA).
Progression Free Survival (PFS) Baseline to Disease Progression or Death from Any Cause (Up to 16 months) PFS was defined as the time from date of first dose to the first observation of disease progression or death from any cause. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST version 1.1) criteria. PD is ≥20% increase in sum of longest diameter of target lesions and/or a new lesion.
Percentage of Participants With Tumor Response Rate (RR) Baseline to Disease Progression (Up to 11 months) Response rate (RR) was defined using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.1) criteria. Complete Response (CR) was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimeter (mm) and normalization of tumor marker level of non-target lesions; Partial Response (PR) was defined as having at least a 30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD) was defined as having at least 20% increase in sum of longest diameter of target lesions and minimum 5 mm increase above nadir; Stable Disease (SD) was defined as small changes that did not meet above criteria.
Change in Physical Performance Measures Using the 6 Minute Walk Test Baseline, Cycles 2, 4, 6, 8 and 10; Day 1 The 6 minute walk test measured the distance walked in 6 minutes, as quickly as possible, without running.
Change in Physical Performance Measures Using the Time Up and Go (TUG) Test Baseline, Cycles 2, 4, 6, 8 and 10; Day 1 Time Up and Go (TUG) is a timed walking test designed to measure gait performance and balance. It measures in seconds the time taken by an individual to stand up from a standard arm chair (approximate seat height of 46 cm \[18in\], arm height 65 cm \[25.6 in\]), walk a distance of 3 meters (118 inches, approximately 10 feet), turn, walk back to the chair, and sit down.
Change in Physical Performance Measures Using Stair Climbing Time (StC) Baseline, Cycles 3, 5, 7, 9 and 11; Day 1 Stair climbing time (StC) measured the ascend and descend of a flight of 12 steps (each step 18 cm high and 28 cm deep).
Change in Patient Reported Outcomes (PRO) Baseline, Cycles 2, 4, 6, 8 and 10; Day 1 Data from PRO scales are not be presented. An error in coding the scales (coded differently early and late in the study) occurred. Unable to determine which results were affected therefore analysis not completed.
Change in Pain Scale Physical Functioning Baseline, Cycles 2, 4, 6, 8 and 10; Day 1 The 36-item Short-Form Health Survey (SF-36) pain scale is a generic, health-related scale assessing participant's quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary \[MCS\] and physical component summary \[PCS\]). The PCS physical functioning domain score ranges from 0 to 100 (higher scores indicate better health status).
Number of Participants With Anti-LY2495655 Antibodies Cycle 1, Day 1 and Day 29 (Pre-Dose); Cycle 6 Day 1
Trial Locations
- Locations (1)
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
🇬🇧Cardiff, South Glamorgan, United Kingdom