A Study of Nab-Paclitaxel and Gemcitabine With or Without Olaratumab (LY3012207) in Participants With Metastatic Pancreatic Cancer
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
3 other identifiers
interventional
184
3 countries
34
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jun 2017
Longer than P75 for phase_1
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 13, 2017
CompletedFirst Posted
Study publicly available on registry
March 22, 2017
CompletedStudy Start
First participant enrolled
June 22, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 5, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 17, 2021
CompletedResults Posted
Study results publicly available
January 11, 2022
CompletedJune 28, 2022
June 1, 2022
3.5 years
March 13, 2017
December 14, 2021
June 3, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
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: 1. Any febrile neutropenia 2. Grade 4 thrombocytopenia, or Grade 3 thrombocytopenia complicated by clinically significant hemorrhage 3. Grade 4 neutropenia lasting 7 days or longer 4. 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. 5. 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 (9)
Phase 1b/2: Pharmacokinetics (PK): Minimum Concentration (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
Baseline through Follow-up (Up To 29 Months)
Phase 1b: Overall Survival (OS)
Baseline to Date of Death from Any Cause (Approximately 9 Months)
Phase 2: Progression-Free Survival (PFS)
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)
Baseline through Disease Progression or Death (Up To 26 Months)
- +4 more secondary outcomes
Study Arms (5)
Phase1b: Olaratumab 15 mg/kg + Nab-paclitaxel + Gemcitabine
EXPERIMENTALParticipants 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.
Phase1b: Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine
EXPERIMENTALParticipants 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.
Phase1b (cohort expansion): Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine
EXPERIMENTALFollowing 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 2: Olaratumab + Nab-paclitaxel + Gemcitabine
EXPERIMENTALParticipants 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.
Phase 2: Placebo + Nab-paclitaxel + Gemcitabine
PLACEBO COMPARATORParticipants 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.
Interventions
Administered IV
Administered IV
Administered IV
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (34)
TGen Clinical Research Services at Scottsdale Healthcare
Scottsdale, Arizona, 85258, United States
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
Madison, Wisconsin, 53792-4108, United States
Charité Campus Virchow-Klinikum
Berlin, 13353, Germany
Hospital Universitari Vall d'Hebron
Barcelona, 08035, Spain
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- 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
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 13, 2017
First Posted
March 22, 2017
Study Start
June 22, 2017
Primary Completion
January 5, 2021
Study Completion
June 17, 2021
Last Updated
June 28, 2022
Results First Posted
January 11, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, 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.
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.