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A Phase 2 Study of LY2495655 in Participants With Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT01505530
Recruitment Status : Completed
First Posted : January 6, 2012
Results First Posted : June 20, 2018
Last Update Posted : June 20, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

January 4, 2012
January 6, 2012
May 21, 2018
June 20, 2018
June 20, 2018
December 2011
October 2014   (Final data collection date for primary outcome measure)
Overall Survival (OS) [ Time Frame: 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.
Overall survival [ Time Frame: Baseline to study completion (approximately 31 months) ]
Complete list of historical versions of study NCT01505530 on ClinicalTrials.gov Archive Site
  • Progression Free Survival (PFS) [ Time Frame: 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) [ Time Frame: 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.
  • Duration of Response [ Time Frame: 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 Lean Body Mass [ Time Frame: Baseline, Cycles 3, 5, 7, 9 and 11; Day 1 ]
    Change in lean body mass was assessed using dual-energy x-ray absorptiometry (DXA).
  • Change in Physical Performance Measures Using Hand Grip Strength [ Time Frame: 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 Physical Performance Measures Using the Time Up and Go (TUG) Test [ Time Frame: 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 the 6 Minute Walk Test [ Time Frame: 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 Stair Climbing Time (StC) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Cycle 1, Day 1 and Day 29 (Pre-Dose); Cycle 6 Day 1 ]
  • Percentage of participants with tumor response (tumor response rate) [ Time Frame: Baseline to study completion (approximately 31 months) ]
  • Change in physical performance measures [ Time Frame: Baseline to study completion (approximately 31 months) ]
  • Change in patient reported outcomes [ Time Frame: Baseline to study completion (approximately 31 months) ]
  • Change in Lean Body Mass [ Time Frame: Baseline to study completion (approximately 31 months) ]
  • Progression free survival (PFS) [ Time Frame: Baseline to study completion (approximately 31 months) ]
  • Duration of response [ Time Frame: Baseline to study completion (approximately 31 months) ]
Not Provided
Not Provided
 
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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Pancreatic Cancer
  • Drug: LY2495655
    Intravenous (IV) treatment every 14 days while on study. Number of Cycles: until treatment options are exhausted or unacceptable toxicity develops.
  • 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 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).
  • Experimental: 300 mg LY2495655 + chemotherapy
    300 mg LY2495655 intravenous (IV) in combination with standard of care chemotherapy (investigator's choice)
    Interventions:
    • Drug: LY2495655
    • Drug: Standard of Care Chemotherapy
  • Experimental: 100 mg LY2495655 + chemotherapy
    100 mg LY2495655 intravenous (IV) in combination with standard of care chemotherapy (investigator's choice)
    Interventions:
    • Drug: LY2495655
    • Drug: Standard of Care Chemotherapy
  • Placebo Comparator: Placebo + chemotherapy
    Placebo in combination with standard of care chemotherapy (investigator's choice)
    Interventions:
    • Drug: Placebo
    • Drug: Standard of Care Chemotherapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
125
120
January 2016
October 2014   (Final data collection date for primary outcome measure)

Inclusion:

  • 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

Exclusion:

  • 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)
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   Israel,   Norway,   United Kingdom,   United States
Belgium
 
NCT01505530
12552
I1Q-MC-JDDG ( Other Identifier: Eli Lilly and Company )
No
Not Provided
Plan to Share IPD: Yes
Plan Description:

Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com.

This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.

Eli Lilly and Company
Eli Lilly and Company
Not Provided
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
Eli Lilly and Company
May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP