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Gemcitabine

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

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

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

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

LY2495655

Placebo

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 regimen or FOLFIRINOX will be determined by the investigator (based on the standard of care used at the treating institution or as directed by local regulatory authorities).

Standard of Care Chemotherapy

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)

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.

A Phase 2 Study of LY2495655 in Participants With Pancreatic Cancer

A Randomized Phase 2 Placebo-Controlled Study of LY2495655 in Patients With Advanced or Metastatic Pancreatic Cancer Receiving Chemotherapy

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Overall survival (OS) duration was measured from the date of randomization to the date of death from any cause.

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.

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.

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 lean body mass was assessed using dual-energy x-ray absorptiometry (DXA).

Hand grip strength (HGS) of the non-dominant hand measured using a hand dynamometer.

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.

The 6 minute walk test measured the distance walked in 6 minutes, as quickly as possible, without running.

Stair climbing time (StC) measured the ascend and descend of a flight of 12 steps (each step 18 cm high and 28 cm deep).

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.

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).

Eli Lilly and Company

All randomized participants who received at least one dose of study drug.

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

LY2495655: Intravenous (IV) treatment every 14 days while on study.

300 mg LY2495655

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

LY2495655: Intravenous (IV) treatment every 14 days while on study.

100 mg LY2495655

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

Placebo: Intravenous (IV) treatment every 14 days while on study.

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

300 mg LY2495655 + Chemotherapy

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

100 mg LY2495655 + Chemotherapy

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

Placebo + Chemotherapy

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Chief Medical Officer

All randomized participants. Participants who were alive at data cut-off for the OS analysis or lost to follow-up were censored on the last date the participant was known to be alive. Censored participants; 300 mg LY2495655 = 9,100 mg LY2495655 =13, Placebo= 16.

Overall Survival (OS)

Progression Free Survival (PFS)

Percentage of Participants With Tumor Response Rate (RR)

Duration of Response

Baseline

Cycle 3

Cycle 5

Cycle 7

Cycle 9

Cycle 11

All participants that received at least one dose of study drug and had evaluable post-baseline measurements.

Change in Lean Body Mass

Cycle 2

Cycle 4

Cycle 6

Cycle 8

Cycle 10

Change in Physical Performance Measures Using Hand Grip Strength

Change in Physical Performance Measures Using the Time Up and Go (TUG) Test

Change in Physical Performance Measures Using the 6 Minute Walk Test

Change in Physical Performance Measures Using Stair Climbing Time (StC)

Zero participants analyzed. 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 Patient Reported Outcomes (PRO)

All randomized participants with evaluable SF-36 domain scores.

Change in Pain Scale Physical Functioning

Number of Participants With Anti-LY2495655 Antibodies

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Phase 2 Study of LY2495655 in Participants With Pancreatic Cancer	NCT01505530	Pancreatic Canc...	LY2495655 Placebo Standard of Car...	18 Years -	Eli Lilly and Company
A Phase 2 Study of LY2495655 in Participants With Pancreatic Cancer	NCT01505530	Pancreatic Canc...	LY2495655 Placebo Standard of Car...	18 Years -	Eli Lilly and Company

Spots Global Cancer Trial Database for ly2495655

Every month we try and update this database with for ly2495655 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for ly2495655

Every month we try and update this database with for ly2495655 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for ly2495655 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.