A Phase 1b/2 Study of OMP-59R5 (Tarextumab) in Combination With Nab-Paclitaxel and Gemcitabine in Subjects With Previously Untreated Stage IV Pancreatic Cancer
ALPINE
1 other identifier
interventional
217
1 country
26
Brief Summary
The study consists of a Phase1b lead-in portion to determine the maximum tolerated dose (MTD) of OMP-59R5 in combination with nab-paclitaxel and gemcitabine followed by a Phase 2, multicenter, randomized, placebo-controlled portion to evaluate the efficacy and safety of OMP-59R5 in combination with nab-paclitaxel and gemcitabine in subjects with previously untreated stage IV 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 Oct 2012
Typical duration for phase_1
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 11, 2012
CompletedFirst Posted
Study publicly available on registry
July 24, 2012
CompletedStudy Start
First participant enrolled
October 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2016
CompletedResults Posted
Study results publicly available
February 15, 2023
CompletedFebruary 15, 2023
January 1, 2023
3.5 years
July 11, 2012
March 12, 2018
January 19, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Phase Ib: Number of Participants With Dose-limiting Toxicities (DLT)
Number of participants with dose-limiting toxicities when administered OMP-59R5 every of other week (Days 1 and 15) in combination with nab-paclitaxel (Nab-P) 125 mg/m2 and gemcitabine (Gem) 1000 mg/m2 on Days 1, 8, and 15 of every 28-day cycle in subjects with previously untreated stage IV pancreatic cancer. In the event that no DLTs are observed, maximum tested dose would be considered the Maximum Tolerated Dose (MTD).
Up to 1 year in absence of unacceptable toxicity or disease progression.
Phase 2: Overall Survival (ITT Population)
To determine the clinical benefit, as measured by overall survival (OS) ofthe addition of OMP-59R5 to nab-paclitaxel and gemcitabine in all subjects who are receiving first-line therapy for stage IV pancreatic cancer.
Up to 1 year in absence of unacceptable toxicity or disease progression.
Phase 2: Median OS by Notch 3 Percentile (ITT Population)
To determine the clinical benefit, as measured by OS of the addition of OMP-59R5 to Nab-P+Gem across the 4 subject subsets: subjects with Notch3 ≥ 25th percentile, subjects with Notch3 ≥ 50th percentile, subjects with Notch3 ≥ 75th percentile and all subjects receiving first-line therapy for stage IV pancreatic cancer with Notch3 high expression level.
Up to 1 year in absence of unacceptable toxicity or disease progression.
Study Arms (2)
OMP-59R5 plus Gemcitabine and Nab-Paclitaxel
EXPERIMENTALOMP-59R5 plus Gemcitabine and Nab-Paclitaxel
Gemcitabine and Nab-Paclitaxel plus Placebo
EXPERIMENTALGemcitabine and Nab-Paclitaxel plus Placebo
Interventions
administered intravenously
administered intravenously
Eligibility Criteria
You may qualify if:
- years of age or older
- Histologically or cytologically documented stage IV ductal adenocarcinoma of the pancreas.
- Performance Status (ECOG) 0 or 1
- FFPE tumor tissue from metastatic site(s
- Adequate organ function
- Written consent on an IRB/IEC-approved Informed Consent Form prior to any study-specific evaluation.
- For women of child-bearing potential, negative serum pregnancy test at screening and use of physician-approved method of birth control from 30 days prior to the first study drug administration to 30 days following the last study drug administration.
- Male subjects must be surgically sterile or must agree to use physician-approved contraception from 30 days prior to the first study drug administration to 30 days following the last study drug administration.
You may not qualify if:
- Neuroendocrine tumors (i.e., carcinoid, islet cell cancer) of the pancreas.
- Known brain metastases.
- Prior therapy, including systemic therapy, surgical resection or radiation for newly diagnosed stage IV pancreatic cancer.
- Presence of any serious or unstable concomitant systemic disorder incompatible with the clinical study (e.g., substance abuse, uncontrolled intercurrent illness including active infection, arterial thrombosis, symptomatic pulmonary embolism).
- Any disorder that would significantly compromise protocol compliance.
- Prior non-pancreatic malignancy treated with chemotherapy. Prior malignancies treated with surgery and/or radiotherapy alone must be in remission ≥3 years. The following prior malignancies are allowable irrespective of when they occurred: in situ carcinoma of the cervix, in situ ductal breast cancer, low-grade local bladder cancer, and nonmelanotic skin cancer.
- Known human immunodeficiency virus (HIV) infection.
- Females who are pregnant or breastfeeding.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
Western Regional Medical Center, Inc.
Goodyear, Arizona, 85338, United States
CBCC Global Research, Inc. at Comprehensive Blood and Cancer Center
Bakersfield, California, 93309, United States
St Jude Heritage Healthcare Virginia K. Crosson Cancer Center
Fullerton, California, 92835, United States
Pacific Shores Medical Group
Long Beach, California, 90813, United States
Ronald Reagan UCLA Medical Center, Drug Information Center, Department of Pharmaceutical Services
Los Angeles, California, 90095, United States
Torrance Health Association Dba Torrance Memorial Physician Network/Cancer Care Associates
Redondo Beach, California, 90277, United States
Rocky Mountain Cancer Centers
Denver, Colorado, 80218, United States
Orlando Health, Inc.
Orlando, Florida, 32806, United States
Northside Hospital, Inc. - GCS/Almex
Atlanta, Georgia, 30341, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
University of Michigan Health System
Ann Arbor, Michigan, 48109, United States
Allina Health, Virginia Piper Cancer Institute
Minneapolis, Minnesota, 55407, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Comprehensive Cancer Centers ofNevada
Las Vegas, Nevada, 89128, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Oncology Hematology Care, Inc.
Cincinnati, Ohio, 45242, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Peggy and Charles Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104, United States
Bend Memorial Clinic
Bend, Oregon, 97701, United States
Greenville Health System, Clinical Research Unit, Institute for Translational Oncology Research
Greenville, South Carolina, 29605, United States
Sarah Cannon Research Institute
Nashville, Tennessee, 37203, United States
South Texas Accelerated Research Thereapeutics, LLC (START)
San Antonio, Texas, 78229, United States
Virginia Mason Medical Center
Seattle, Washington, 98101, United States
University of Wiscons in Hospi tal and Clinics
Madison, Wisconsin, 53792, United States
Froedtert Hospital & Medical College of Wisconsin
Milwaukee, Wisconsin, 533226, United States
Related Publications (1)
Hu ZI, Bendell JC, Bullock A, LoConte NK, Hatoum H, Ritch P, Hool H, Leach JW, Sanchez J, Sohal DPS, Strickler J, Patel R, Wang-Gillam A, Firdaus I, Yu KH, Kapoun AM, Holmgren E, Zhou L, Dupont J, Picozzi V, Sahai V, O'Reilly EM. A randomized phase II trial of nab-paclitaxel and gemcitabine with tarextumab or placebo in patients with untreated metastatic pancreatic cancer. Cancer Med. 2019 Sep;8(11):5148-5157. doi: 10.1002/cam4.2425. Epub 2019 Jul 26.
PMID: 31347292DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Manager, Regulatory Affairs
- Organization
- OncoMed Pharmaceuticals, Inc.
Study Officials
- PRINCIPAL INVESTIGATOR
Eileen M O'Reilly, MD
Memorial Sloan Kettering Cancer Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
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
July 11, 2012
First Posted
July 24, 2012
Study Start
October 1, 2012
Primary Completion
April 1, 2016
Study Completion
April 1, 2016
Last Updated
February 15, 2023
Results First Posted
February 15, 2023
Record last verified: 2023-01