A Phase 2 Study Of LY2495655 In Participants With Pancreatic Cancer

Study Overview

A Phase 2 Study of LY2495655 in Participants With Pancreatic Cancer

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.

N/A

Pancreatic Cancer

DRUG: LY2495655
DRUG: Placebo
DRUG: Standard of Care Chemotherapy

12552
I1Q-MC-JDDG (OTHER Identifier) (OTHER: Eli Lilly and Company)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2012-01-04	Results First Submitted 2018-05-21	Last Update Submitted that met QC Criteria 2019-09-06
First Submitted that Met QC Criteria 2012-01-04	Results First Submitted that Met QC Criteria 2018-05-21	Last Update Posted (ACTUAL) 2019-09-18
First Posted (ACTUAL) 2012-01-06	Results First Posted 2018-06-20	Last Verified 2019-09

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
Triple

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: 300 mg LY2495655 + chemotherapy 300 mg LY2495655 intravenous (IV) in combination with standard of care chemotherapy (investigator's choice)	DRUG: LY2495655 Intravenous (IV) treatment every 14 days while on study. Number of Cycles: until treatment options are exhausted or unacceptable toxicity develops. DRUG: Standard of Care Chemotherapy Standard of care, gemcitabine-based regimen (single-agent gemcitabine or gemcitabine plus erlotinib) or FOLFIRINOX (combination chemotherapy regimen including 5-fluorouracil, leucovorin, oxaliplatin, and irinotecan). The choice of gemcitabine-based regime
EXPERIMENTAL: 100 mg LY2495655 + chemotherapy 100 mg LY2495655 intravenous (IV) in combination with standard of care chemotherapy (investigator's choice)	DRUG: LY2495655 Intravenous (IV) treatment every 14 days while on study. Number of Cycles: until treatment options are exhausted or unacceptable toxicity develops. DRUG: Standard of Care Chemotherapy Standard of care, gemcitabine-based regimen (single-agent gemcitabine or gemcitabine plus erlotinib) or FOLFIRINOX (combination chemotherapy regimen including 5-fluorouracil, leucovorin, oxaliplatin, and irinotecan). The choice of gemcitabine-based regime
PLACEBO_COMPARATOR: Placebo + chemotherapy Placebo in combination with standard of care chemotherapy (investigator's choice)	DRUG: Placebo Intravenous (IV) treatment every 14 days while on study. Number of Cycles: until treatment options are exhausted or unacceptable toxicity develops. DRUG: Standard of Care Chemotherapy Standard of care, gemcitabine-based regimen (single-agent gemcitabine or gemcitabine plus erlotinib) or FOLFIRINOX (combination chemotherapy regimen including 5-fluorouracil, leucovorin, oxaliplatin, and irinotecan). The choice of gemcitabine-based regime

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: 300 mg LY2495655 + chemotherapy

300 mg LY2495655 intravenous (IV) in combination with standard of care chemotherapy (investigator's choice)

DRUG: LY2495655

Intravenous (IV) treatment every 14 days while on study. Number of Cycles: until treatment options are exhausted or unacceptable toxicity develops.

DRUG: Standard of Care Chemotherapy

Standard of care, gemcitabine-based regimen (single-agent gemcitabine or gemcitabine plus erlotinib) or FOLFIRINOX (combination chemotherapy regimen including 5-fluorouracil, leucovorin, oxaliplatin, and irinotecan). The choice of gemcitabine-based regime

EXPERIMENTAL: 100 mg LY2495655 + chemotherapy

100 mg LY2495655 intravenous (IV) in combination with standard of care chemotherapy (investigator's choice)

DRUG: LY2495655

Intravenous (IV) treatment every 14 days while on study. Number of Cycles: until treatment options are exhausted or unacceptable toxicity develops.

DRUG: Standard of Care Chemotherapy

Standard of care, gemcitabine-based regimen (single-agent gemcitabine or gemcitabine plus erlotinib) or FOLFIRINOX (combination chemotherapy regimen including 5-fluorouracil, leucovorin, oxaliplatin, and irinotecan). The choice of gemcitabine-based regime

PLACEBO_COMPARATOR: Placebo + chemotherapy

Placebo in combination with standard of care chemotherapy (investigator's choice)

DRUG: Placebo

Intravenous (IV) treatment every 14 days while on study. Number of Cycles: until treatment options are exhausted or unacceptable toxicity develops.

DRUG: Standard of Care Chemotherapy

Standard of care, gemcitabine-based regimen (single-agent gemcitabine or gemcitabine plus erlotinib) or FOLFIRINOX (combination chemotherapy regimen including 5-fluorouracil, leucovorin, oxaliplatin, and irinotecan). The choice of gemcitabine-based regime

Primary Outcome Measures	Measure Description	Time Frame
Overall Survival (OS)	Overall survival (OS) duration was measured from the date of randomization to the date of death from any cause.	Baseline to Death from Any Cause (Up to 23 months)

Secondary Outcome Measures	Measure Description	Time Frame
Progression Free Survival (PFS)	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.	Baseline to Disease Progression or Death from Any Cause (Up to 16 months)
Percentage of Participants With Tumor Response Rate (RR)	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.	Baseline to Disease Progression (Up to 11 months)
Duration of Response	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.	First CR or PR to Disease Progression (Up to 11 months)
Change in Lean Body Mass	Change in lean body mass was assessed using dual-energy x-ray absorptiometry (DXA).	Baseline, Cycles 3, 5, 7, 9 and 11; Day 1
Change in Physical Performance Measures Using Hand Grip Strength	Hand grip strength (HGS) of the non-dominant hand measured using a hand dynamometer.	Baseline, Cycles 2, 4, 6, 8 and 10; Day 1
Change in Physical Performance Measures Using the Time Up and Go (TUG) Test	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.	Baseline, Cycles 2, 4, 6, 8 and 10; Day 1
Change in Physical Performance Measures Using the 6 Minute Walk Test	The 6 minute walk test measured the distance walked in 6 minutes, as quickly as possible, without running.	Baseline, Cycles 2, 4, 6, 8 and 10; Day 1
Change in Physical Performance Measures Using Stair Climbing Time (StC)	Stair climbing time (StC) measured the ascend and descend of a flight of 12 steps (each step 18 cm high and 28 cm deep).	Baseline, Cycles 3, 5, 7, 9 and 11; Day 1
Change in Patient Reported Outcomes (PRO)	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.	Baseline, Cycles 2, 4, 6, 8 and 10; Day 1
Change in Pain Scale Physical Functioning	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).	Baseline, Cycles 2, 4, 6, 8 and 10; Day 1
Number of Participants With Anti-LY2495655 Antibodies		Cycle 1, Day 1 and Day 29 (Pre-Dose); Cycle 6 Day 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Unresectable or metastatic pancreas cancer; participants with previous radical surgery for pancreas cancer are eligible after progression is documented
Participants may have received previous adjuvant treatment with gemcitabine with or without radiotherapy for pancreas cancer
ECOG (Eastern Cooperative Oncology Group) 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

Prior systemic therapy for unresectable/metastatic pancreas cancer
Any medical or psychiatric condition, orthopedic or neuromuscular conditions that could limit participation or confound study results
Currently taking medications that are considered both muscle building and performance enhancing (for example, androgen therapies, or anabolic steroids)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_DIRECTOR: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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