Clinical trial NCT01647828: 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
Official title: A Phase 1b/2 Study of OMP-59R5 in Combination With Nab-Paclitaxel and Gemcitabine in Subjects With Previously Untreated Stage IV Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Stage IV Pancreatic Cancer
Keywords: Newly diagnosed Stage IV Pancreatic Cancer
Lead sponsor: Mereo BioPharma
Sponsor class: INDUSTRY
First posted: 2012-07-24
Enrollment: 217
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

Subjects must meet all of the following major inclusion criteria to be eligible for the study:

1. 18 years of age or older
2. Histologically or cytologically documented stage IV ductal adenocarcinoma of the pancreas.
3. Performance Status (ECOG) 0 or 1
4. FFPE tumor tissue from metastatic site(s
5. Adequate organ function
6. Written consent on an IRB/IEC-approved Informed Consent Form prior to any study-specific evaluation.
7. 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.
8. 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.

Exclusion Criteria:

Subjects who meet any of the following major exclusion criteria will not be eligible for participation in the study:

1. Neuroendocrine tumors (i.e., carcinoid, islet cell cancer) of the pancreas.
2. Known brain metastases.
3. Prior therapy, including systemic therapy, surgical resection or radiation for newly diagnosed stage IV pancreatic cancer.
4. 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).
5. Any disorder that would significantly compromise protocol compliance.
6. 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.
7. Known human immunodeficiency virus (HIV) infection.
8. Females who are pregnant or breastfeeding.

Primary outcomes:
measure: Phase Ib: Number of Participants With Dose-limiting Toxicities (DLT)
timeFrame: Up to 1 year in absence of unacceptable toxicity or disease progression.
measure: Phase 2: Overall Survival (ITT Population)
timeFrame: Up to 1 year in absence of unacceptable toxicity or disease progression.
measure: Phase 2: Median OS by Notch 3 Percentile (ITT Population)
timeFrame: Up to 1 year in absence of unacceptable toxicity or disease progression.
Secondary outcomes:
Other outcomes:
Locations:
city: Goodyear
country: United States
facility: Western Regional Medical Center, Inc.
state: Arizona
city: Bakersfield
country: United States
facility: CBCC Global Research, Inc. at Comprehensive Blood and Cancer Center
state: California
city: Fullerton
country: United States
facility: St Jude Heritage Healthcare Virginia K. Crosson Cancer Center
state: California
city: Long Beach
country: United States
facility: Pacific Shores Medical Group
state: California
city: Los Angeles
country: United States
facility: Ronald Reagan UCLA Medical Center, Drug Information Center, Department of Pharmaceutical Services
state: California
city: Redondo Beach
country: United States
facility: Torrance Health Association Dba Torrance Memorial Physician Network/Cancer Care Associates
state: California
city: Denver
country: United States
facility: Rocky Mountain Cancer Centers
state: Colorado
city: Orlando
country: United States
facility: Orlando Health, Inc.
state: Florida
city: Atlanta
country: United States
facility: Northside Hospital, Inc. - GCS/Almex
state: Georgia
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
city: Minneapolis
country: United States
facility: Allina Health, Virginia Piper Cancer Institute
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers ofNevada
state: Nevada
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: Oncology Hematology Care, Inc.
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Oklahoma City
country: United States
facility: Peggy and Charles Stephenson Cancer Center
state: Oklahoma
city: Bend
country: United States
facility: Bend Memorial Clinic
state: Oregon
city: Greenville
country: United States
facility: Greenville Health System, Clinical Research Unit, Institute for Translational Oncology Research
state: South Carolina
city: Nashville
country: United States
facility: Sarah Cannon Research Institute
state: Tennessee
city: San Antonio
country: United States
facility: South Texas Accelerated Research Thereapeutics, LLC (START)
state: Texas
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: Madison
country: United States
facility: University of Wiscons in Hospi tal and Clinics
state: Wisconsin
city: Milwaukee
country: United States
facility: Froedtert Hospital & Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Eileen M O'Reilly, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.