Clinical trial NCT03086369: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Metastatic Pancreatic Cancer
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2017-03-22
Enrollment: 184
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Phase 1b: Number of Participants With Dose Limiting Toxicities (DLTs)
timeFrame: Cycle 1 (Up to 28 days)
measure: Phase 2: Overall Survival (OS)
timeFrame: Baseline to Date of Death from Any Cause (Up To 29 Months)
Secondary outcomes:
measure: Phase 1b/2: Pharmacokinetics (PK): Minimum Concentration (Cmin) of Olaratumab
timeFrame: 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
measure: Phase 2: Number of Participants With Treatment Emergent Anti-Olaratumab Antibodies
timeFrame: Baseline through Follow-up (Up To 29 Months)
measure: Phase 1b: Overall Survival (OS)
timeFrame: Baseline to Date of Death from Any Cause (Approximately 9 Months)
measure: Phase 2: Progression-Free Survival (PFS)
timeFrame: Baseline to Disease Progression or Death (Up To 26 Months)
measure: Phase 1b/2: Objective Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR)
timeFrame: Baseline through Disease Progression or Death (Up To 26 Months)
measure: Phase 1b/2: Duration of Response (DoR)
timeFrame: From Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Up To 19 Months)
measure: Phase 2: Time to First Worsening of the Brief Pain Inventory Short Form Modified (mBPI-sf) "Worst Pain Score"
timeFrame: Baseline through Follow-up (Up To 21 Months)
measure: 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.
timeFrame: Baseline through Follow-up (Up To 21 Months)
measure: Phase 2: Health Status on the EuroQol 5-Dimension 5 Level (EQ-5D-5L)
timeFrame: Cycle 1 Day 1, Cycle 7 Day 1
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: TGen Clinical Research Services at Scottsdale Healthcare
state: Arizona
city: Tucson
country: United States
facility: University of Arizona Cancer Center
state: Arizona
city: Fayetteville
country: United States
facility: Highlands Oncology Group
state: Arkansas
city: Bakersfield
country: United States
facility: Comprehensive Blood and Cancer Center
state: California
city: Fullerton
country: United States
facility: St Jude Medical Center
state: California
city: Los Angeles
country: United States
facility: TRIO - Translational Research in Oncology-US, Inc.
state: California
city: Los Angeles
country: United States
facility: UCLA Medical Center
state: California
city: Santa Barbara
country: United States
facility: Cancer Center of Santa Barbara with Sansum Clinic
state: California
city: Santa Maria
country: United States
facility: Central Coast Medical Oncology Corporation
state: California
city: New Haven
country: United States
facility: Smilow Cancer Hospital at Yale-New Haven
state: Connecticut
city: Fort Myers
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Saint Petersburg
country: United States
facility: Florida Cancer Specialists and Research Institute
state: Florida
city: Tampa
country: United States
facility: H Lee Moffitt Cancer Center
state: Florida
city: Fort Wayne
country: United States
facility: Fort Wayne Oncology & Hematology
state: Indiana
city: Wichita
country: United States
facility: Cancer Center of Kansas
state: Kansas
city: Omaha
country: United States
facility: Nebraska Methodist Hospital
state: Nebraska
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada
state: Nevada
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey
state: New Jersey
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: Lake Success
country: United States
facility: Monter Cancer Center
state: New York
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Hillman Cancer Center
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Sioux Falls
country: United States
facility: Sanford Research/USD
state: South Dakota
city: Chattanooga
country: United States
facility: Chattanooga Oncology Hematology Associates
state: Tennessee
city: Nashville
country: United States
facility: Sarah Cannon Research Institute SCRI
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Oncology PLLC
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: San Antonio
country: United States
facility: Univ of Texas Health Science Center at San Antonio
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah School of Medicine
state: Utah
city: Madison
country: United States
facility: University of Wisconsin-Madison Hospital and Health Clinic
state: Wisconsin
city: Berlin
country: Germany
facility: Charité Campus Virchow-Klinikum
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: