A Study of Nab-Paclitaxel and Gemcitabine With or Without... | NCT03086369 | Trialant
NCT03086369
Sponsor
Eli Lilly and Company
Status
Completed
Last Update Posted
Jun 28, 2022Actual
Enrollment
184Actual
Phase
Phase 1Phase 2
Conditions
Metastatic Pancreatic Cancer
Interventions
Olaratumab
Nab-paclitaxel
Gemcitabine
Placebo
Countries
United States
Germany
Spain
Protocol Section
Identification Module
NCT ID
NCT03086369
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
15844
Secondary IDs
ID
Type
Description
Link
I5B-MC-JGDP
Other Identifier
Eli Lilly and Company
2016-001099-31
EudraCT Number
Brief Title
A Study of Nab-Paclitaxel and Gemcitabine With or Without Olaratumab (LY3012207) in Participants With Metastatic Pancreatic Cancer
Official Title
A Phase 1b (Open-Label) / Phase 2 (Randomized, Double-Blinded) Study Evaluating Nab-Paclitaxel and Gemcitabine With or Without Olaratumab in the Treatment of First-Line Metastatic Pancreatic Cancer
Acronym
Not provided
Organization
Eli Lilly and CompanyINDUSTRY
Status Module
Record Verification Date
Jun 2022
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jun 22, 2017Actual
Primary Completion Date
Jan 5, 2021Actual
Completion Date
Jun 17, 2021Actual
First Submitted Date
Mar 13, 2017
First Submission Date that Met QC Criteria
Mar 20, 2017
First Posted Date
Mar 22, 2017Actual
Results Waived
Not provided
Results First Submitted Date
Dec 14, 2021
Results First Submitted that Met QC Criteria
Dec 14, 2021
Results First Posted Date
Jan 11, 2022Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jun 3, 2022
Last Update Posted Date
Jun 28, 2022Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Eli Lilly and CompanyINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to determine the safety and efficacy of nab-paclitaxel and gemcitabine with or without olaratumab in the treatment of first-line metastatic pancreatic cancer.
Participants received intravenous (IV) infusions of olaratumab 15 milligrams per kilogram (mg/kg), nab-paclitaxel 125 milligrams per meter square (mg/m^2) and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.
Participants received intravenous infusions of olaratumab 20 mg/kg, nab-paclitaxel 125 mg/m^2 and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.
Following a protocol amendment, "cohort expansion" arm was added in phase 1b with new participants enrolled to confirm the safety of the olaratumab 20 mg/kg dose prior to opening the Phase 2. Participants received intravenous infusions of olaratumab 20 mg/kg, nab-paclitaxel 125 mg/m^2 and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.
Phase 1b: Number of Participants With Dose Limiting Toxicities (DLTs)
A DLT is defined as an adverse event that is likely related to the study medication or combination, and fulfils any one of the following criteria, graded according to the NCI-CTCAE version 4.03:
Any febrile neutropenia
Grade 4 thrombocytopenia, or Grade 3 thrombocytopenia complicated by clinically significant hemorrhage
Grade 4 neutropenia lasting 7 days or longer
Nonhematologic Grade ≥3 toxicity, except for toxicities such as nausea, vomiting, transient electrolyte abnormalities, diarrhea which can be controlled with optimal medical management within 48 hours; non-clinically significant, treatable, or reversible laboratory abnormalities including liver function tests, uric acid, electrolytes, etc.
Any other significant toxicity deemed to be dose-limiting (e.g., any toxicity that is possibly related to the study medication that requires the withdrawal of the participant from the study during Cycle 1).
Cycle 1 (Up to 28 days)
Phase 2: Overall Survival (OS)
OS is defined as the time from the date of randomization to the date of death from any cause. If the participant is alive or lost to follow-up at the time of data analysis, OS data will be censored on the last date the participant is known to be alive. For any participant who has withdrawn consent for further follow-up of survival data, OS will be censored at the last date for which the participant consented to be followed for the study.
Baseline to Date of Death from Any Cause (Up To 29 Months)
Secondary Outcomes
Measure
Description
Time Frame
Phase 1b/2: Pharmacokinetics (PK): Minimum Concentration (Cmin) of Olaratumab
PK: Cmin of olaratumab
Pre-dose, 5 min, 1, 4, 4.5, 24, 96, 168, 336 h post-dose on Cycle 1 Day 1, Cycle 1 Day 15, Cycle 3 Day 1, Cycle 3 Day 15
Phase 2: Number of Participants With Treatment Emergent Anti-Olaratumab Antibodies
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Histological or cytological diagnosis of adenocarcinoma of the exocrine pancreas that is metastatic (Stage IV) and not amenable to resection with curative intent.
If present, clinically significant or symptomatic amounts of ascites should be drained prior to Day 1.
Have had no prior systemic treatment for metastatic disease. Prior adjuvant or neo-adjuvant chemotherapy or radiochemotherapy (other than nab-paclitaxel) is allowed if completed ≥3 months prior to enrollment and no lingering toxicities are present.
Prior radiation therapy for treatment of cancer is allowed to <25% of the bone marrow.
Phase 2: archival tumor tissue or be willing to provide a pre-treatment biopsy.
Measurable or nonmeasurable but evaluable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
Discontinued all previous treatments for cancer ≥4 weeks prior.
Adequate organ function.
Life expectancy of at least 3 months.
Exclusion Criteria:
Serious concomitant systemic disorder.
Have received first line treatment for metastatic pancreatic cancer.
Received prior treatment with nab-paclitaxel.
Have known central nervous system malignancy or metastasis.
Current hematologic malignancies.
Participated within the last 30 days in a clinical trial involving an investigational product.
Women with a positive pregnancy test or lactating.
Have endocrine pancreatic tumors or ampullary cancer.
Currently enrolled in another clinical trial.
Have a known additional malignancy that is progressing or required active treatment within the past 1 year.
Known allergy to nab-paclitaxel or gemcitabine or any ingredient of study drug formulations.
Are taking certain anti-coagulant medications such as warfarin and are unable to be switched to other similar medicines.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
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
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
TGen Clinical Research Services at Scottsdale Healthcare
Scottsdale
Arizona
85258
United States
References Module
Citations
Not provided
See Also Links
Label
URL
A Study of Nab-Paclitaxel and Gemcitabine With or Without Olaratumab (LY3012207) in Participants With Metastatic Pancreatic Cancer
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.
Types
Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Participants received intravenous infusions of olaratumab 15 milligrams per kilogram (mg/kg), nab-paclitaxel 125 milligrams per meter square (mg/m^2) and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Mar 20, 2019
Oct 5, 2021
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Italy
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
Participants received intravenous infusions of olaratumab 20 mg/kg loading dose on days 1, 8, 15 of cycle 1 followed by 15 mg/kg on days 1, 8, 15 of all subsequent cycles, in combination with nab-paclitaxel 125 mg/m^2 and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.
Drug: Olaratumab
Drug: Nab-paclitaxel
Drug: Gemcitabine
Phase 2: Placebo + Nab-paclitaxel + Gemcitabine
Placebo Comparator
Participants received intravenous infusions of placebo, nab-paclitaxel 125 mg/m^2 and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.
Number of Participants With Treatment Emergent Anti-Olaratumab Antibodies
Baseline through Follow-up (Up To 29 Months)
Phase 1b: Overall Survival (OS)
OS is defined as the time from the date of randomization to the date of death from any cause. If the participant is alive or lost to follow-up at the time of data analysis, OS data will be censored on the last date the participant is known to be alive. For any participant who has withdrawn consent for further follow-up of survival data, OS will be censored at the last date for which the participant consented to be followed for the study.
Baseline to Date of Death from Any Cause (Approximately 9 Months)
Phase 2: Progression-Free Survival (PFS)
PFS is defined as the time from randomization to the first date of radiologic disease progression (as defined by Response Evaluation Criteria In Solid Tumors, Version 1.1 [RECIST v.1.1]) or death due to any cause in the absence of progressive disease (PD). PD is defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. Participants who did not progress or are lost to follow-up were censored at the day of their last radiographic tumor assessment, if available, or date of randomization if no post-baseline radiographic assessment is available. If death or PD occurs after 2 or more consecutive missing radiographic visits, censoring will occur at the date of the last radiographic visit prior to the missed visits.
Baseline to Disease Progression or Death (Up To 26 Months)
Phase 1b/2: Objective Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR)
ORR is the best overall tumor response of CR or PR as classified by the investigator according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions.
Baseline through Disease Progression or Death (Up To 26 Months)
Phase 1b/2: Duration of Response (DoR)
DoR is defined as the time from the date measurement criteria for CR or PR (whichever is first recorded) are first met until the first date that disease is recurrent or objective progression is observed, per RECIST 1.1 criteria, or the date of death from any cause in the absence of objectively determined disease progression or recurrence.
From Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Up To 19 Months)
Phase 2: Time to First Worsening of the Brief Pain Inventory Short Form Modified (mBPI-sf) "Worst Pain Score"
The mBPI-sf is a 11-item instrument used as a multiple-item measure of cancer pain intensity ranging from 0 (no pain or does not interfere) and ranged through 10 (pain as bad as you can imagine or completely interferes). Time to first worsening of the mBPI-sf "worst pain score" (TWP) was defined as the time from the date of randomization to the first date of either a "worst pain" score increase of greater than or equal to (≥) 2 points from baseline or an analgesic drug class increase of ≥1 level. If the participant has not worsened by either of these criteria, TWP was censored for analysis on the last date the mBPI-sf was administered.
Baseline through Follow-up (Up To 21 Months)
Phase 2: Time to First Worsening of Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Symptom Scales.
The EORTC QLQ-C30 is a self-reported general cancer instrument consisting of 30 items covered by 1 of 3 dimensions: global health status/quality of life (2 items), functional scales (15 total items addressing either physical, role, emotional, cognitive, or social functioning), symptom scales (13 total items addressing either fatigue, nausea/vomiting, pain, dyspnoea, insomnia, appetite loss, constipation, diarrhoea, or financial impact). Time to first worsening of Symptom Burden was defined as the time from randomization to the first observation of worsening on symptom scales (i.e.,) increase of at least 10 points from baseline. For symptom scales, a linear transformation was used to obtain total score ranging from 0 to 100, a high score represents a high level of symptomatology or problems.
Baseline through Follow-up (Up To 21 Months)
Phase 2: Health Status on the EuroQol 5-Dimension 5 Level (EQ-5D-5L)
The EQ-5D-5L is a standardized instrument for use as a measure of self-reported health status. Five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) of health status are each assessed with 5 response options (1=no problem, 2=slight, 3=moderate, 4=severe, and 5=extreme problem) and scored as a composite index which were anchored on a scale of 0 to 1 with a higher score representing better health status. Additionally, current health status was assessed on a visual analogue scale (VAS) ranging from 0 to 100 with a higher score representing better health status.
Cycle 1 Day 1, Cycle 7 Day 1
University of Arizona Cancer Center
Tucson
Arizona
85724
United States
Highlands Oncology Group
Fayetteville
Arkansas
72703
United States
Comprehensive Blood and Cancer Center
Bakersfield
California
93309
United States
St Jude Medical Center
Fullerton
California
92835
United States
TRIO - Translational Research in Oncology-US, Inc.
Los Angeles
California
90024
United States
UCLA Medical Center
Los Angeles
California
90095
United States
Cancer Center of Santa Barbara with Sansum Clinic
Santa Barbara
California
93105
United States
Central Coast Medical Oncology Corporation
Santa Maria
California
93454
United States
Smilow Cancer Hospital at Yale-New Haven
New Haven
Connecticut
06510
United States
Florida Cancer Specialists
Fort Myers
Florida
33901
United States
Florida Cancer Specialists and Research Institute
St. Petersburg
Florida
33705
United States
H Lee Moffitt Cancer Center
Tampa
Florida
33612-9497
United States
Fort Wayne Oncology & Hematology
Fort Wayne
Indiana
46845
United States
Cancer Center of Kansas
Wichita
Kansas
67214
United States
Nebraska Methodist Hospital
Omaha
Nebraska
68114
United States
Comprehensive Cancer Centers of Nevada
Las Vegas
Nevada
89169
United States
Dartmouth Hitchcock Medical Center
Lebanon
New Hampshire
03756-0001
United States
Rutgers Cancer Institute of New Jersey
New Brunswick
New Jersey
08901
United States
Roswell Park Cancer Institute
Buffalo
New York
14263-0002
United States
Monter Cancer Center
Lake Success
New York
11042
United States
Thomas Jefferson University
Philadelphia
Pennsylvania
19107
United States
UPMC Hillman Cancer Center
Pittsburgh
Pennsylvania
15232-1305
United States
Medical University of South Carolina
Charleston
South Carolina
29425
United States
Sanford Research/USD
Sioux Falls
South Dakota
57104
United States
Chattanooga Oncology Hematology Associates
Chattanooga
Tennessee
37404
United States
Sarah Cannon Research Institute SCRI
Nashville
Tennessee
37203
United States
Tennessee Oncology PLLC
Nashville
Tennessee
37203
United States
Vanderbilt University Medical Center
Nashville
Tennessee
37232-6307
United States
Univ of Texas Health Science Center at San Antonio
San Antonio
Texas
78229
United States
University of Utah School of Medicine
Salt Lake City
Utah
84112
United States
University of Wisconsin-Madison Hospital and Health Clinic
Participants received intravenous infusions of olaratumab 20 mg/kg, nab-paclitaxel 125 mg/m^2 and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.
Following a protocol amendment, "cohort expansion" arm was added in phase 1b with new participants enrolled to confirm the safety of the olaratumab 20 mg/kg dose prior to opening the Phase 2. Participants received intravenous infusions of olaratumab 20 mg/kg, nab-paclitaxel 125 mg/m^2 and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.
Participants received intravenous infusions of olaratumab 20 mg/kg loading dose on days 1, 8, 15 of cycle 1 followed by 15 mg/kg on days 1, 8, 15 of all subsequent cycles, in combination with nab-paclitaxel 125 mg/m^2 and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.
FG004
Phase 2: Placebo + Nab-paclitaxel + Gemcitabine
Participants received intravenous infusions of placebo, nab-paclitaxel 125 mg/m^2 and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.
Participants received intravenous infusions of olaratumab 15 mg/kg, nab-paclitaxel 125 mg/m^2 and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.
Participants received intravenous infusions of olaratumab 20 mg/kg, nab-paclitaxel 125 mg/m^2 and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.
Following a protocol amendment, "cohort expansion" arm was added in phase 1b with new participants enrolled to confirm the safety of the olaratumab 20 mg/kg dose prior to opening the Phase 2. Participants received intravenous infusions of olaratumab 20 mg/kg, nab-paclitaxel 125 mg/m^2 and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.
Participants received intravenous infusions of olaratumab 20 mg/kg loading dose on days 1, 8, 15 of cycle 1 followed by 15 mg/kg on days 1, 8, 15 of all subsequent cycles, in combination with nab-paclitaxel 125 mg/m^2 and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.
BG004
Phase 2: Placebo + Nab-paclitaxel + Gemcitabine
Participants received intravenous infusions of placebo, nab-paclitaxel 125 mg/m^2 and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.
BG005
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0003
BG0017
BG00212
BG00382
BG00480
BG005184
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG003
Sex: Female, Male
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Female
BG0002
BG0013
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
BG002
Race (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Region of Enrollment
Count of Participants
Participants
No
Title
Denominators
Categories
United States
Title
Measurements
BG0001
BG0015
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Phase 1b: Number of Participants With Dose Limiting Toxicities (DLTs)
A DLT is defined as an adverse event that is likely related to the study medication or combination, and fulfils any one of the following criteria, graded according to the NCI-CTCAE version 4.03:
Any febrile neutropenia
Grade 4 thrombocytopenia, or Grade 3 thrombocytopenia complicated by clinically significant hemorrhage
Grade 4 neutropenia lasting 7 days or longer
Nonhematologic Grade ≥3 toxicity, except for toxicities such as nausea, vomiting, transient electrolyte abnormalities, diarrhea which can be controlled with optimal medical management within 48 hours; non-clinically significant, treatable, or reversible laboratory abnormalities including liver function tests, uric acid, electrolytes, etc.
Any other significant toxicity deemed to be dose-limiting (e.g., any toxicity that is possibly related to the study medication that requires the withdrawal of the participant from the study during Cycle 1).
All participants in phase 1b who received at least one dose of Olaratumab.
Participants received intravenous infusions of olaratumab 15 mg/kg, nab-paclitaxel 125 mg/m^2 and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.
Participants received intravenous infusions of olaratumab 20 mg/kg, nab-paclitaxel 125 mg/m^2 and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.
Following a protocol amendment, "cohort expansion" arm was added in phase 1b with new participants enrolled to confirm the safety of the olaratumab 20 mg/kg dose prior to opening the Phase 2. Participants received intravenous infusions of olaratumab 20 mg/kg, nab-paclitaxel 125 mg/m^2 and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.
Units
Counts
Participants
OG0003
OG0017
OG00212
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
Primary
Phase 2: Overall Survival (OS)
OS is defined as the time from the date of randomization to the date of death from any cause. If the participant is alive or lost to follow-up at the time of data analysis, OS data will be censored on the last date the participant is known to be alive. For any participant who has withdrawn consent for further follow-up of survival data, OS will be censored at the last date for which the participant consented to be followed for the study.
All randomized participants in phase 2 (including the censored participants). Number of participants censored in Olaratumab+Nab-paclitaxel+Gemcitabine=26, Placebo+Nab-paclitaxel+Gemcitabine=21.
Posted
Median
95% Confidence Interval
Months
Baseline to Date of Death from Any Cause (Up To 29 Months)
Participants received intravenous infusions of olaratumab 20 mg/kg loading dose on days 1, 8, 15 of cycle 1 followed by 15 mg/kg on days 1, 8, 15 of all subsequent cycles, in combination with nab-paclitaxel 125 mg/m^2 and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.
OG001
Phase 2: Placebo + Nab-paclitaxel + Gemcitabine
Participants received intravenous infusions of placebo, nab-paclitaxel 125 mg/m^2 and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.
Secondary
Phase 1b/2: Pharmacokinetics (PK): Minimum Concentration (Cmin) of Olaratumab
PK: Cmin of olaratumab
All participants in phase 1b/2 who received at least one dose of Olaratumab and had evaluable PK data.
Posted
Geometric Mean
Geometric Coefficient of Variation
micrograms per milliliter (μg/mL)
Pre-dose, 5 min, 1, 4, 4.5, 24, 96, 168, 336 h post-dose on Cycle 1 Day 1, Cycle 1 Day 15, Cycle 3 Day 1, Cycle 3 Day 15
Participants received intravenous infusions of olaratumab 15 mg/kg, nab-paclitaxel 125 mg/m^2 and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.
Participants received intravenous infusions of olaratumab 20 mg/kg, nab-paclitaxel 125 mg/m^2 and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.
Following a protocol amendment, "cohort expansion" arm was added in phase 1b with new participants enrolled to confirm the safety of the olaratumab 20 mg/kg dose prior to opening the Phase 2. Participants received intravenous infusions of olaratumab 20 mg/kg, nab-paclitaxel 125 mg/m^2 and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.
Secondary
Phase 2: Number of Participants With Treatment Emergent Anti-Olaratumab Antibodies
Number of Participants With Treatment Emergent Anti-Olaratumab Antibodies
All randomized participants in phase 2 who received at least one dose of Olaratumab and had evaluable immunogenicity data.
Participants received intravenous infusions of olaratumab 20 mg/kg loading dose on days 1, 8, 15 of cycle 1 followed by 15 mg/kg on days 1, 8, 15 of all subsequent cycles, in combination with nab-paclitaxel 125 mg/m^2 and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.
Units
Counts
Participants
OG000
Secondary
Phase 1b: Overall Survival (OS)
OS is defined as the time from the date of randomization to the date of death from any cause. If the participant is alive or lost to follow-up at the time of data analysis, OS data will be censored on the last date the participant is known to be alive. For any participant who has withdrawn consent for further follow-up of survival data, OS will be censored at the last date for which the participant consented to be followed for the study.
Phase 1b: Zero participants analysed as data was not collected. OS was not measured in phase 1b.
Posted
Baseline to Date of Death from Any Cause (Approximately 9 Months)
Participants received intravenous infusions of olaratumab 15 mg/kg, nab-paclitaxel 125 mg/m^2 and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.
Participants received intravenous infusions of olaratumab 20 mg/kg, nab-paclitaxel 125 mg/m^2 and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.
PFS is defined as the time from randomization to the first date of radiologic disease progression (as defined by Response Evaluation Criteria In Solid Tumors, Version 1.1 [RECIST v.1.1]) or death due to any cause in the absence of progressive disease (PD). PD is defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. Participants who did not progress or are lost to follow-up were censored at the day of their last radiographic tumor assessment, if available, or date of randomization if no post-baseline radiographic assessment is available. If death or PD occurs after 2 or more consecutive missing radiographic visits, censoring will occur at the date of the last radiographic visit prior to the missed visits.
All randomized participants in phase 2 (including the censored participants). Number of participants censored in Olaratumab+Nab-paclitaxel+Gemcitabine=24, Placebo+Nab-paclitaxel+Gemcitabine=26.
Posted
Median
95% Confidence Interval
Months
Baseline to Disease Progression or Death (Up To 26 Months)
Participants received intravenous infusions of olaratumab 20 mg/kg loading dose on days 1, 8, 15 of cycle 1 followed by 15 mg/kg on days 1, 8, 15 of all subsequent cycles, in combination with nab-paclitaxel 125 mg/m^2 and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.
Secondary
Phase 1b/2: Objective Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR)
ORR is the best overall tumor response of CR or PR as classified by the investigator according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions.
All participants in phase 1b/2.
Posted
Number
Percentage of participants
Baseline through Disease Progression or Death (Up To 26 Months)
Participants received intravenous infusions of olaratumab 15 mg/kg, nab-paclitaxel 125 mg/m^2 and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.
Participants received intravenous infusions of olaratumab 20 mg/kg, nab-paclitaxel 125 mg/m^2 and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.
OG002
Secondary
Phase 1b/2: Duration of Response (DoR)
DoR is defined as the time from the date measurement criteria for CR or PR (whichever is first recorded) are first met until the first date that disease is recurrent or objective progression is observed, per RECIST 1.1 criteria, or the date of death from any cause in the absence of objectively determined disease progression or recurrence.
All participants in phase 1b/2 who had CR or PR responses. For phase 1b cohort expansion arm, there were no participants with CR or PR responses to evaluate DoR, hence, zero participants analysed.
Posted
Median
95% Confidence Interval
Months
From Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Up To 19 Months)
Participants received intravenous infusions of olaratumab 15 mg/kg, nab-paclitaxel 125 mg/m^2 and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.
Participants received intravenous infusions of olaratumab 20 mg/kg, nab-paclitaxel 125 mg/m^2 and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.
OG002
Secondary
Phase 2: Time to First Worsening of the Brief Pain Inventory Short Form Modified (mBPI-sf) "Worst Pain Score"
The mBPI-sf is a 11-item instrument used as a multiple-item measure of cancer pain intensity ranging from 0 (no pain or does not interfere) and ranged through 10 (pain as bad as you can imagine or completely interferes). Time to first worsening of the mBPI-sf "worst pain score" (TWP) was defined as the time from the date of randomization to the first date of either a "worst pain" score increase of greater than or equal to (≥) 2 points from baseline or an analgesic drug class increase of ≥1 level. If the participant has not worsened by either of these criteria, TWP was censored for analysis on the last date the mBPI-sf was administered.
All randomized participants in phase 2 who had baseline and at least one post-baseline assessment.
Participants received intravenous infusions of olaratumab 20 mg/kg loading dose on days 1, 8, 15 of cycle 1 followed by 15 mg/kg on days 1, 8, 15 of all subsequent cycles, in combination with nab-paclitaxel 125 mg/m^2 and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.
OG001
Phase 2: Placebo + Nab-paclitaxel + Gemcitabine
Participants received intravenous infusions of placebo, nab-paclitaxel 125 mg/m^2 and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.
Secondary
Phase 2: Time to First Worsening of Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Symptom Scales.
The EORTC QLQ-C30 is a self-reported general cancer instrument consisting of 30 items covered by 1 of 3 dimensions: global health status/quality of life (2 items), functional scales (15 total items addressing either physical, role, emotional, cognitive, or social functioning), symptom scales (13 total items addressing either fatigue, nausea/vomiting, pain, dyspnoea, insomnia, appetite loss, constipation, diarrhoea, or financial impact). Time to first worsening of Symptom Burden was defined as the time from randomization to the first observation of worsening on symptom scales (i.e.,) increase of at least 10 points from baseline. For symptom scales, a linear transformation was used to obtain total score ranging from 0 to 100, a high score represents a high level of symptomatology or problems.
All randomized participants in phase 2 who had baseline and at least one post-baseline assessment.
Participants received intravenous infusions of olaratumab 20 mg/kg loading dose on days 1, 8, 15 of cycle 1 followed by 15 mg/kg on days 1, 8, 15 of all subsequent cycles, in combination with nab-paclitaxel 125 mg/m^2 and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.
Secondary
Phase 2: Health Status on the EuroQol 5-Dimension 5 Level (EQ-5D-5L)
The EQ-5D-5L is a standardized instrument for use as a measure of self-reported health status. Five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) of health status are each assessed with 5 response options (1=no problem, 2=slight, 3=moderate, 4=severe, and 5=extreme problem) and scored as a composite index which were anchored on a scale of 0 to 1 with a higher score representing better health status. Additionally, current health status was assessed on a visual analogue scale (VAS) ranging from 0 to 100 with a higher score representing better health status.
All randomized participants in phase 2 who completed EQ-5D-5L.
Participants received intravenous infusions of olaratumab 20 mg/kg loading dose on days 1, 8, 15 of cycle 1 followed by 15 mg/kg on days 1, 8, 15 of all subsequent cycles, in combination with nab-paclitaxel 125 mg/m^2 and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.
OG001
Phase 2: Placebo + Nab-paclitaxel + Gemcitabine
Participants received intravenous infusions of placebo, nab-paclitaxel 125 mg/m^2 and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.
Time Frame
Baseline to Follow-up (Up To 29 Months)
Description
All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Participants received intravenous infusions of olaratumab 15 mg/kg, nab-paclitaxel 125 mg/m^2 and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.
Participants received intravenous infusions of olaratumab 20 mg/kg, nab-paclitaxel 125 mg/m^2 and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.
Following a protocol amendment, "cohort expansion" arm was added in phase 1b with new participants enrolled to confirm the safety of the olaratumab 20 mg/kg dose prior to opening the Phase 2. Participants received intravenous infusions of olaratumab 20 mg/kg, nab-paclitaxel 125 mg/m^2 and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.
Participants received intravenous infusions of olaratumab 20 mg/kg loading dose on days 1, 8, 15 of cycle 1 followed by 15 mg/kg on days 1, 8, 15 of all subsequent cycles, in combination with nab-paclitaxel 125 mg/m^2 and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.
60
81
50
81
79
81
EG004
Phase 2: Placebo + Nab-paclitaxel + Gemcitabine
Participants received intravenous infusions of placebo, nab-paclitaxel 125 mg/m^2 and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.
Participants received intravenous infusions of olaratumab 20 mg/kg loading dose on days 1, 8, 15 of cycle 1 followed by 15 mg/kg on days 1, 8, 15 of all subsequent cycles, in combination with nab-paclitaxel 125 mg/m^2 and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.
Units
Counts
Participants
OG0003
OG0015
OG0029
OG00366
Title
Denominators
Categories
Cycle 1 (Day 1)
ParticipantsOG0003
ParticipantsOG0015
ParticipantsOG0029
ParticipantsOG00361
Title
Measurements
OG000128± 36
OG00186.3± 90
OG00287.8± 91
OG003
Cycle 1 (Day 15)
ParticipantsOG0003
ParticipantsOG0015
ParticipantsOG0029
ParticipantsOG00366
Cycle 3 (Day 1)
ParticipantsOG0003
ParticipantsOG0011
ParticipantsOG0029
ParticipantsOG00351
Cycle 3 (Day 15)
ParticipantsOG0003
ParticipantsOG0011
ParticipantsOG0029
ParticipantsOG00344
81
Title
Denominators
Categories
Title
Measurements
OG0000
Following a protocol amendment, "cohort expansion" arm was added in phase 1b with new participants enrolled to confirm the safety of the olaratumab 20 mg/kg dose prior to opening the Phase 2. Participants received intravenous infusions of olaratumab 20 mg/kg, nab-paclitaxel 125 mg/m^2 and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG001
Phase 2: Placebo + Nab-paclitaxel + Gemcitabine
Participants received intravenous infusions of placebo, nab-paclitaxel 125 mg/m^2 and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.
Units
Counts
Participants
OG00082
OG00180
Title
Denominators
Categories
Title
Measurements
OG0005.55(4.14 to 7.0)
OG0016.41(5.42 to 7.98)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Log Rank
Stratified by age group (<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).
0.3771
Hazard Ratio (HR)
1.192
2-Sided
95
0.806
1.764
Stratified by age group (<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).
Following a protocol amendment, "cohort expansion" arm was added in phase 1b with new participants enrolled to confirm the safety of the olaratumab 20 mg/kg dose prior to opening the Phase 2. Participants received intravenous infusions of olaratumab 20 mg/kg, nab-paclitaxel 125 mg/m^2 and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.
Participants received intravenous infusions of olaratumab 20 mg/kg loading dose on days 1, 8, 15 of cycle 1 followed by 15 mg/kg on days 1, 8, 15 of all subsequent cycles, in combination with nab-paclitaxel 125 mg/m^2 and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.
OG004
Phase 2: Placebo + Nab-paclitaxel + Gemcitabine
Participants received intravenous infusions of placebo, nab-paclitaxel 125 mg/m^2 and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.
Following a protocol amendment, "cohort expansion" arm was added in phase 1b with new participants enrolled to confirm the safety of the olaratumab 20 mg/kg dose prior to opening the Phase 2. Participants received intravenous infusions of olaratumab 20 mg/kg, nab-paclitaxel 125 mg/m^2 and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.
Participants received intravenous infusions of olaratumab 20 mg/kg loading dose on days 1, 8, 15 of cycle 1 followed by 15 mg/kg on days 1, 8, 15 of all subsequent cycles, in combination with nab-paclitaxel 125 mg/m^2 and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.
OG004
Phase 2: Placebo + Nab-paclitaxel + Gemcitabine
Participants received intravenous infusions of placebo, nab-paclitaxel 125 mg/m^2 and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.
Units
Counts
Participants
OG0001
OG0011
OG0020
OG00325
OG00427
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Median and 95% Confidence Interval couldn't be calculated as there was only one participant. Individual value reported: 6.24 months.
OG001NA(NA to NA)Median and 95% Confidence Interval couldn't be calculated as there was only one participant. Individual value reported: 3.68 months.
OG0035.55(2.63 to 9.23)
OG0045.55(3.84 to 7.26)
Units
Counts
Participants
OG00051
OG00147
Title
Denominators
Categories
Title
Measurements
OG00014.13(5.19 to NA)There were not enough events to estimate the upper confidence limit.
OG0016.11(2.04 to 9.95)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Log Rank
Stratified by age group (<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).
0.017
Hazard Ratio (HR)
0.390
2-Sided
95
0.175
0.872
Superiority
OG001
Phase 2: Placebo + Nab-paclitaxel + Gemcitabine
Participants received intravenous infusions of placebo, nab-paclitaxel 125 mg/m^2 and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.
Units
Counts
Participants
OG00068
OG00166
Title
Denominators
Categories
Appetite loss
ParticipantsOG00057
ParticipantsOG00160
Title
Measurements
OG000NA(2.79 to NA)There were not enough events to estimate median, upper confidence limit.
OG0012.86(1.94 to NA)There were not enough events to estimate upper confidence limit.
Constipation
ParticipantsOG00064
ParticipantsOG00159
Title
Measurements
OG000NA(2.76 to NA)There were not enough events to estimate median, upper confidence limit.
OG001
Diarrhoea
ParticipantsOG00068
ParticipantsOG00162
Title
Measurements
OG0002.79(1.87 to NA)There were not enough events to estimate upper confidence limit.
OG001
Dyspnoea
ParticipantsOG00066
ParticipantsOG00166
Title
Measurements
OG0002.79(2.10 to NA)There were not enough events to estimate upper confidence limit.
OG001
Fatigue
ParticipantsOG00066
ParticipantsOG00164
Title
Measurements
OG0001.87(1.05 to 2.33)
OG001
Financial difficulties
ParticipantsOG00065
ParticipantsOG00161
Title
Measurements
OG000NA(2.37 to NA)There were not enough events to estimate median, upper confidence limit.
OG001
Insomnia
ParticipantsOG00060
ParticipantsOG00160
Title
Measurements
OG0003.19(2.10 to NA)There were not enough events to estimate upper confidence limit.
OG001
Nausea and vomiting
ParticipantsOG00066
ParticipantsOG00166
Title
Measurements
OG0003.19(2.10 to NA)There were not enough events to estimate upper confidence limit.
OG001
Pain
ParticipantsOG00064
ParticipantsOG00158
Title
Measurements
OG000NA(2.76 to NA)There were not enough events to estimate median, upper confidence limit.
OG001
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Appetite loss
Log Rank
Stratified by age group (<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).
0.288
Hazard Ratio (HR)
0.718
2-Sided
95
0.392
1.317
Stratified by age group (<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).
Superiority
OG000
OG001
Constipation
Log Rank
Stratified by age group (<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).
0.442
Hazard Ratio (HR)
0.788
2-Sided
95
0.423
1.468
Stratified by age group (<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).
Superiority
OG000
OG001
Diarrhoea
Log Rank
Stratified by age group (<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).
0.883
Hazard Ratio (HR)
1.037
2-Sided
95
0.612
1.755
Stratified by age group (<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).
Superiority
OG000
OG001
Dyspnoea
Log Rank
Stratified by age group (<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).
0.803
Hazard Ratio (HR)
0.933
2-Sided
95
0.532
1.636
Stratified by age group (<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).
Superiority
OG000
OG001
Fatigue
Log Rank
Stratified by age group (<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).
0.805
Hazard Ratio (HR)
1.053
2-Sided
95
0.675
1.645
Stratified by age group (<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).
Superiority
OG000
OG001
Financial difficulties
Log Rank
Stratified by age group (<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).
0.465
Hazard Ratio (HR)
0.784
2-Sided
95
0.420
1.464
Stratified by age group (<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).
Superiority
OG000
OG001
Insomnia
Log Rank
Stratified by age group (<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).
0.231
Hazard Ratio (HR)
1.457
2-Sided
95
0.787
2.698
Stratified by age group (<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).
Superiority
OG000
OG001
Nausea and vomiting
Log Rank
Stratified by age group (<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).
0.748
Hazard Ratio (HR)
0.914
2-Sided
95
0.532
1.570
Stratified by age group (<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).
Superiority
OG000
OG001
Pain
Log Rank
Stratified by age group (<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).
0.875
Hazard Ratio (HR)
0.947
2-Sided
95
0.491
1.827
Stratified by age group (<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).
Superiority
Units
Counts
Participants
OG00070
OG00170
Title
Denominators
Categories
Index Value [Cycle 1 (Day1)]
ParticipantsOG00069
ParticipantsOG00170
Title
Measurements
OG0000.8± 0.2
OG0010.8± 0.2
Index Value [Cycle 7 (Day1)]
ParticipantsOG00022
ParticipantsOG00133
Title
Measurements
OG0000.8± 0.1
OG001
VAS Score [Cycle 1 (Day1)]
ParticipantsOG00070
ParticipantsOG00170
Title
Measurements
OG00070.1± 21.7
OG001
VAS Score [Cycle 7 (Day1)]
ParticipantsOG00023
ParticipantsOG00133
Title
Measurements
OG00071.7± 20.2
OG001
0 events
0 affected
78 at risk
1 events
1 affected
81 at risk
EG0041 events1 affected78 at risk
1 events
1 affected
81 at risk
EG0040 events0 affected78 at risk
0 events
0 affected
81 at risk
EG0041 events1 affected78 at risk
1 events
1 affected
81 at risk
EG0040 events0 affected78 at risk
0 events
0 affected
81 at risk
EG0041 events1 affected78 at risk
1 events
1 affected
81 at risk
EG0040 events0 affected78 at risk
1 events
1 affected
81 at risk
EG0042 events2 affected78 at risk
1 events
1 affected
81 at risk
EG0040 events0 affected78 at risk
0 events
0 affected
81 at risk
EG0041 events1 affected78 at risk
1 events
1 affected
81 at risk
EG0042 events2 affected78 at risk
0 events
0 affected
81 at risk
EG0041 events1 affected78 at risk
0 events
0 affected
81 at risk
EG0041 events1 affected78 at risk
2 events
2 affected
81 at risk
EG0042 events2 affected78 at risk
1 events
1 affected
81 at risk
EG0040 events0 affected78 at risk
2 events
2 affected
81 at risk
EG0040 events0 affected78 at risk
1 events
1 affected
81 at risk
EG0040 events0 affected78 at risk
0 events
0 affected
81 at risk
EG0041 events1 affected78 at risk
4 events
4 affected
81 at risk
EG0041 events1 affected78 at risk
1 events
1 affected
81 at risk
EG0040 events0 affected78 at risk
1 events
1 affected
81 at risk
EG0040 events0 affected78 at risk
1 events
1 affected
81 at risk
EG0040 events0 affected78 at risk
1 events
1 affected
81 at risk
EG0040 events0 affected78 at risk
1 events
1 affected
81 at risk
EG0040 events0 affected78 at risk
2 events
2 affected
81 at risk
EG0041 events1 affected78 at risk
1 events
1 affected
81 at risk
EG0040 events0 affected78 at risk
0 events
0 affected
81 at risk
EG0040 events0 affected78 at risk
1 events
1 affected
81 at risk
EG0040 events0 affected78 at risk
2 events
2 affected
81 at risk
EG0040 events0 affected78 at risk
3 events
2 affected
81 at risk
EG0041 events1 affected78 at risk
2 events
2 affected
81 at risk
EG0041 events1 affected78 at risk
1 events
1 affected
81 at risk
EG0041 events1 affected78 at risk
1 events
1 affected
81 at risk
EG0040 events0 affected78 at risk
0 events
0 affected
81 at risk
EG0041 events1 affected78 at risk
1 events
1 affected
81 at risk
EG0040 events0 affected78 at risk
5 events
5 affected
81 at risk
EG0044 events4 affected78 at risk
2 events
2 affected
81 at risk
EG0040 events0 affected78 at risk
0 events
0 affected
81 at risk
EG0042 events2 affected78 at risk
0 events
0 affected
81 at risk
EG0041 events1 affected78 at risk
0 events
0 affected
81 at risk
EG0041 events1 affected78 at risk
2 events
1 affected
81 at risk
EG0042 events2 affected78 at risk
0 events
0 affected
81 at risk
EG0041 events1 affected78 at risk
2 events
2 affected
81 at risk
EG0041 events1 affected78 at risk
0 events
0 affected
81 at risk
EG0041 events1 affected78 at risk
1 events
1 affected
81 at risk
EG0040 events0 affected78 at risk
0 events
0 affected
81 at risk
EG0041 events1 affected78 at risk
0 events
0 affected
81 at risk
EG0040 events0 affected78 at risk
0 events
0 affected
81 at risk
EG0042 events2 affected78 at risk
1 events
1 affected
81 at risk
EG0041 events1 affected78 at risk
1 events
1 affected
81 at risk
EG0040 events0 affected78 at risk
1 events
1 affected
81 at risk
EG0040 events0 affected78 at risk
2 events
2 affected
81 at risk
EG0040 events0 affected78 at risk
0 events
0 affected
81 at risk
EG0041 events1 affected78 at risk
1 events
1 affected
81 at risk
EG0040 events0 affected78 at risk
2 events
2 affected
81 at risk
EG0042 events1 affected78 at risk
0 events
0 affected
81 at risk
EG0041 events1 affected78 at risk
1 events
1 affected
81 at risk
EG0041 events1 affected78 at risk
1 events
1 affected
81 at risk
EG0049 events8 affected78 at risk
0 events
0 affected
81 at risk
EG0041 events1 affected78 at risk
0 events
0 affected
81 at risk
EG0040 events0 affected78 at risk
7 events
7 affected
81 at risk
EG0042 events2 affected78 at risk
2 events
2 affected
81 at risk
EG0042 events2 affected78 at risk
0 events
0 affected
81 at risk
EG0041 events1 affected78 at risk
1 events
1 affected
81 at risk
EG0041 events1 affected78 at risk
0 events
0 affected
81 at risk
EG0040 events0 affected78 at risk
0 events
0 affected
81 at risk
EG0041 events1 affected78 at risk
0 events
0 affected
81 at risk
EG0041 events1 affected78 at risk
0 events
0 affected
81 at risk
EG0040 events0 affected78 at risk
0 events
0 affected
81 at risk
EG0040 events0 affected78 at risk
0 events
0 affected
81 at risk
EG0042 events2 affected78 at risk
2 events
2 affected
81 at risk
EG0040 events0 affected78 at risk
1 events
1 affected
81 at risk
EG0040 events0 affected78 at risk
1 events
1 affected
81 at risk
EG0040 events0 affected78 at risk
1 events
1 affected
81 at risk
EG0040 events0 affected78 at risk
0 events
0 affected
81 at risk
EG0041 events1 affected78 at risk
2 events
2 affected
81 at risk
EG0040 events0 affected78 at risk
1 events
1 affected
81 at risk
EG0040 events0 affected78 at risk
1 events
1 affected
81 at risk
EG0040 events0 affected78 at risk
1 events
1 affected
81 at risk
EG0040 events0 affected78 at risk
0 events
0 affected
81 at risk
EG0041 events1 affected78 at risk
0 events
0 affected
81 at risk
EG0041 events1 affected78 at risk
1 events
1 affected
81 at risk
EG0042 events2 affected78 at risk
1 events
1 affected
81 at risk
EG0040 events0 affected78 at risk
0 events
0 affected
81 at risk
EG0040 events0 affected78 at risk
1 events
1 affected
81 at risk
EG0040 events0 affected78 at risk
0 events
0 affected
81 at risk
EG0042 events1 affected78 at risk
2 events
1 affected
81 at risk
EG0040 events0 affected78 at risk
0 events
0 affected
81 at risk
EG0041 events1 affected78 at risk
1 events
1 affected
81 at risk
EG0040 events0 affected78 at risk
0 events
0 affected
81 at risk
EG0040 events0 affected78 at risk
1 events
1 affected
81 at risk
EG0040 events0 affected78 at risk
1 events
1 affected
81 at risk
EG0040 events0 affected78 at risk
1 events
1 affected
81 at risk
EG0040 events0 affected78 at risk
1 events
1 affected
81 at risk
EG0040 events0 affected78 at risk
1 events
1 affected
81 at risk
EG0040 events0 affected78 at risk
1 events
1 affected
81 at risk
EG0041 events1 affected78 at risk
1 events
1 affected
81 at risk
EG0040 events0 affected78 at risk
0 events
0 affected
81 at risk
EG0040 events0 affected78 at risk
2 events
2 affected
81 at risk
EG0040 events0 affected78 at risk
0 events
0 affected
81 at risk
EG0040 events0 affected78 at risk
1 events
1 affected
81 at risk
EG0041 events1 affected78 at risk
0 events
0 affected
81 at risk
EG0041 events1 affected78 at risk
4 events
4 affected
81 at risk
EG0040 events0 affected78 at risk
0 events
0 affected
81 at risk
EG0041 events1 affected78 at risk
1 events
1 affected
81 at risk
EG0040 events0 affected78 at risk
2 events
2 affected
81 at risk
EG0041 events1 affected78 at risk
0 events
0 affected
81 at risk
EG0040 events0 affected78 at risk
0 events
0 affected
81 at risk
EG0041 events1 affected78 at risk
1 events
1 affected
81 at risk
EG0040 events0 affected78 at risk
0 events
0 affected
81 at risk
EG0041 events1 affected78 at risk
1 events
1 affected
81 at risk
EG0042 events2 affected78 at risk
1 events
1 affected
81 at risk
EG0042 events2 affected78 at risk
53 events
20 affected
81 at risk
EG00470 events16 affected78 at risk
19 events
7 affected
81 at risk
EG00493 events12 affected78 at risk
4 events
4 affected
81 at risk
EG0041 events1 affected78 at risk
1 events
1 affected
81 at risk
EG0040 events0 affected78 at risk
3 events
2 affected
81 at risk
EG0043 events2 affected78 at risk
1 events
1 affected
81 at risk
EG0042 events2 affected78 at risk
0 events
0 affected
81 at risk
EG0040 events0 affected78 at risk
1 events
1 affected
81 at risk
EG0040 events0 affected78 at risk
0 events
0 affected
81 at risk
EG0040 events0 affected78 at risk
6 events
6 affected
81 at risk
EG0042 events2 affected78 at risk
1 events
1 affected
81 at risk
EG0043 events2 affected78 at risk
5 events
4 affected
81 at risk
EG0045 events4 affected78 at risk
21 events
15 affected
81 at risk
EG00422 events16 affected78 at risk
6 events
5 affected
81 at risk
EG0047 events5 affected78 at risk
26 events
22 affected
81 at risk
EG00431 events30 affected78 at risk
72 events
40 affected
81 at risk
EG00458 events30 affected78 at risk
3 events
3 affected
81 at risk
EG0045 events4 affected78 at risk
0 events
0 affected
81 at risk
EG0044 events4 affected78 at risk
0 events
0 affected
81 at risk
EG0046 events4 affected78 at risk
1 events
1 affected
81 at risk
EG0041 events1 affected78 at risk
2 events
2 affected
81 at risk
EG0040 events0 affected78 at risk
0 events
0 affected
81 at risk
EG0040 events0 affected78 at risk
46 events
33 affected
81 at risk
EG00462 events39 affected78 at risk
0 events
0 affected
81 at risk
EG0040 events0 affected78 at risk
11 events
9 affected
81 at risk
EG00411 events9 affected78 at risk
26 events
19 affected
81 at risk
EG00423 events19 affected78 at risk
12 events
11 affected
81 at risk
EG00418 events10 affected78 at risk
10 events
8 affected
81 at risk
EG00417 events12 affected78 at risk
74 events
53 affected
81 at risk
EG00484 events44 affected78 at risk
0 events
0 affected
81 at risk
EG0042 events1 affected78 at risk
3 events
3 affected
81 at risk
EG00414 events5 affected78 at risk
3 events
2 affected
81 at risk
EG0040 events0 affected78 at risk
2 events
2 affected
81 at risk
EG0044 events3 affected78 at risk
43 events
25 affected
81 at risk
EG00444 events28 affected78 at risk
2 events
2 affected
81 at risk
EG0044 events4 affected78 at risk
30 events
20 affected
81 at risk
EG00428 events21 affected78 at risk
0 events
0 affected
81 at risk
EG0040 events0 affected78 at risk
0 events
0 affected
81 at risk
EG0040 events0 affected78 at risk
0 events
0 affected
81 at risk
EG0040 events0 affected78 at risk
4 events
4 affected
81 at risk
EG0048 events3 affected78 at risk
0 events
0 affected
81 at risk
EG0040 events0 affected78 at risk
0 events
0 affected
81 at risk
EG0040 events0 affected78 at risk
2 events
2 affected
81 at risk
EG0042 events1 affected78 at risk
7 events
6 affected
81 at risk
EG0045 events5 affected78 at risk
0 events
0 affected
81 at risk
EG0040 events0 affected78 at risk
2 events
2 affected
81 at risk
EG0043 events3 affected78 at risk
7 events
3 affected
81 at risk
EG0045 events2 affected78 at risk
3 events
3 affected
81 at risk
EG0044 events4 affected78 at risk
3 events
3 affected
81 at risk
EG00416 events8 affected78 at risk
1 events
1 affected
81 at risk
EG0040 events0 affected78 at risk
4 events
3 affected
81 at risk
EG0046 events6 affected78 at risk
0 events
0 affected
81 at risk
EG0040 events0 affected78 at risk
0 events
0 affected
81 at risk
EG0040 events0 affected78 at risk
3 events
3 affected
81 at risk
EG0040 events0 affected78 at risk
0 events
0 affected
81 at risk
EG0040 events0 affected78 at risk
4 events
4 affected
81 at risk
EG0046 events5 affected78 at risk
28 events
13 affected
81 at risk
EG00426 events14 affected78 at risk
38 events
15 affected
81 at risk
EG00420 events13 affected78 at risk
23 events
8 affected
81 at risk
EG00420 events9 affected78 at risk
12 events
8 affected
81 at risk
EG00411 events9 affected78 at risk
4 events
3 affected
81 at risk
EG00410 events5 affected78 at risk
13 events
3 affected
81 at risk
EG0040 events0 affected78 at risk
0 events
0 affected
81 at risk
EG0040 events0 affected78 at risk
88 events
12 affected
81 at risk
EG00434 events7 affected78 at risk
184 events
31 affected
81 at risk
EG004128 events25 affected78 at risk
134 events
29 affected
81 at risk
EG004106 events31 affected78 at risk
0 events
0 affected
81 at risk
EG0040 events0 affected78 at risk
36 events
23 affected
81 at risk
EG00414 events9 affected78 at risk
127 events
23 affected
81 at risk
EG00492 events16 affected78 at risk
26 events
22 affected
81 at risk
EG00437 events24 affected78 at risk
20 events
14 affected
81 at risk
EG00430 events15 affected78 at risk
5 events
5 affected
81 at risk
EG00410 events4 affected78 at risk
0 events
0 affected
81 at risk
EG0040 events0 affected78 at risk
60 events
13 affected
81 at risk
EG0047 events4 affected78 at risk
13 events
10 affected
81 at risk
EG0043 events3 affected78 at risk
40 events
19 affected
81 at risk
EG00431 events17 affected78 at risk
27 events
16 affected
81 at risk
EG00420 events12 affected78 at risk
41 events
15 affected
81 at risk
EG00411 events6 affected78 at risk
0 events
0 affected
81 at risk
EG0040 events0 affected78 at risk
3 events
2 affected
81 at risk
EG0049 events7 affected78 at risk
6 events
6 affected
81 at risk
EG00413 events11 affected78 at risk
0 events
0 affected
81 at risk
EG0040 events0 affected78 at risk
2 events
2 affected
81 at risk
EG0045 events4 affected78 at risk
14 events
11 affected
81 at risk
EG0045 events4 affected78 at risk
2 events
1 affected
81 at risk
EG0041 events1 affected78 at risk
8 events
8 affected
81 at risk
EG00412 events8 affected78 at risk
10 events
9 affected
81 at risk
EG00411 events6 affected78 at risk
0 events
0 affected
81 at risk
EG0040 events0 affected78 at risk
1 events
1 affected
81 at risk
EG0040 events0 affected78 at risk
0 events
0 affected
81 at risk
EG0041 events1 affected78 at risk
26 events
20 affected
81 at risk
EG00430 events21 affected78 at risk
11 events
8 affected
81 at risk
EG00415 events13 affected78 at risk
0 events
0 affected
81 at risk
EG0040 events0 affected78 at risk
9 events
6 affected
81 at risk
EG00411 events10 affected78 at risk
4 events
3 affected
81 at risk
EG0044 events4 affected78 at risk
36 events
18 affected
81 at risk
EG00423 events12 affected78 at risk
1 events
1 affected
81 at risk
EG0040 events0 affected78 at risk
3 events
2 affected
81 at risk
EG0045 events3 affected78 at risk
29 events
15 affected
81 at risk
EG00430 events17 affected78 at risk
0 events
0 affected
81 at risk
EG0040 events0 affected78 at risk
0 events
0 affected
81 at risk
EG0044 events4 affected78 at risk
0 events
0 affected
81 at risk
EG0042 events2 affected78 at risk
3 events
3 affected
81 at risk
EG0041 events1 affected78 at risk
0 events
0 affected
81 at risk
EG0040 events0 affected78 at risk
5 events
5 affected
81 at risk
EG00411 events8 affected78 at risk
0 events
0 affected
81 at risk
EG0042 events2 affected78 at risk
0 events
0 affected
81 at risk
EG0040 events0 affected78 at risk
9 events
7 affected
81 at risk
EG0047 events5 affected78 at risk
11 events
10 affected
81 at risk
EG00413 events11 affected78 at risk
0 events
0 affected
81 at risk
EG0041 events1 affected78 at risk
0 events
0 affected
81 at risk
EG0040 events0 affected78 at risk
0 events
0 affected
81 at risk
EG0042 events2 affected78 at risk
0 events
0 affected
81 at risk
EG0041 events1 affected78 at risk
0 events
0 affected
81 at risk
EG0040 events0 affected78 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected35 at risk
14 events
13 affected
81 at risk
EG00410 events10 affected78 at risk
17 events
14 affected
81 at risk
EG00425 events13 affected78 at risk
4 events
4 affected
81 at risk
EG00410 events8 affected78 at risk
2 events
2 affected
81 at risk
EG0044 events4 affected78 at risk
1 events
1 affected
81 at risk
EG0044 events4 affected78 at risk
1 events
1 affected
81 at risk
EG0044 events4 affected78 at risk
4 events
4 affected
81 at risk
EG0044 events4 affected78 at risk
0 events
0 affected
81 at risk
EG0041 events1 affected78 at risk
34 events
28 affected
81 at risk
EG00421 events16 affected78 at risk
0 events
0 affected
81 at risk
EG0042 events2 affected78 at risk
0 events
0 affected
81 at risk
EG0040 events0 affected78 at risk
0 events
0 affected
81 at risk
EG0040 events0 affected78 at risk
0 events
0 affected
81 at risk
EG0040 events0 affected78 at risk
1 events
1 affected
81 at risk
EG0041 events1 affected78 at risk
1 events
1 affected
81 at risk
EG0041 events1 affected78 at risk
5 events
5 affected
81 at risk
EG0045 events5 affected78 at risk
9 events
6 affected
81 at risk
EG00422 events13 affected78 at risk
6 events
4 affected
81 at risk
EG0048 events7 affected78 at risk
0 events
0 affected
81 at risk
EG0040 events0 affected78 at risk
0 events
0 affected
81 at risk
EG0040 events0 affected78 at risk
4 events
1 affected
81 at risk
EG0040 events0 affected78 at risk
0 events
0 affected
81 at risk
EG0040 events0 affected78 at risk
0 events
0 affected
81 at risk
EG0040 events0 affected78 at risk
0 events
0 affected
81 at risk
EG0040 events0 affected78 at risk
3 events
3 affected
81 at risk
EG0044 events4 affected78 at risk
5 events
5 affected
81 at risk
EG0042 events2 affected78 at risk
14 events
7 affected
81 at risk
EG0046 events4 affected78 at risk
18 events
14 affected
81 at risk
EG0047 events6 affected78 at risk
0 events
0 affected
81 at risk
EG0041 events1 affected78 at risk
112
± 40
Title
Measurements
OG00078.7± 42
OG001172± 76
OG002101± 36
OG00394.7± 62
Title
Measurements
OG000204± 13
OG001NA± NAGeometric Mean and Geometric Coefficient of Variation couldn't be calculated as there was only one participant. Individual value reported: 184 μg/mL
OG002173± 33
OG003147± 38
Title
Measurements
OG000159± 17
OG001NA± NAGeometric Mean and Geometric Coefficient of Variation couldn't be calculated as there was only one participant. Individual value reported: 99.7 μg/mL
OG002101± 37
OG003106± 68
NA
(1.94 to NA)
There were not enough events to estimate median, upper confidence limit.
1.97
(1.91 to NA)
There were not enough events to estimate upper confidence limit.
3.12
(2.07 to NA)
There were not enough events to estimate upper confidence limit.
1.87
(1.12 to 2.07)
NA
(2.79 to NA)
There were not enough events to estimate median, upper confidence limit.
NA
(2.83 to NA)
There were not enough events to estimate median, upper confidence limit.
2.86
(1.97 to NA)
There were not enough events to estimate upper confidence limit.
3.25
(2.04 to NA)
There were not enough events to estimate upper confidence limit.