Spots Global Cancer Trial Database for A Phase 1b/2 Study of OMP-59R5 (Tarextumab) in Combination With Etoposide and Platinum Therapy
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Trial Identification
Brief Title: A Phase 1b/2 Study of OMP-59R5 (Tarextumab) in Combination With Etoposide and Platinum Therapy
Official Title: A Phase 1b/2 Study of OMP-59R5 in Combination With Etoposide and Platinum Therapy in Subjects With Untreated Extensive Stage Small Cell Lung Cancer (PINNACLE)
Study ID: NCT01859741
Conditions
Study Description
Brief Summary: The study consists of a Phase1b lead-in portion to determine the maximum tolerated dose (MTD) of OMP-59R5 (tarextumab) in combination with etoposide (EP) for 6 cycles followed a Phase 2, multi center, randomized, placebo-controlled portion comparing the efficacy and safety of OMP-59R5 in combination with EP for 6 cycles followed by single agent OMP-59R5 relative to EP alone for 6 cycles in subjects receiving first-line therapy for extensive stage small cell lung cancer.
Detailed Description: The Phase 1b lead-in portion of the study was conducted to determine the MTD of OMP-59R5 administered along with EP. The Phase 2 portion of the study was multi-center, randomized, and placebo-controlled. Subjects who qualified for enrollment into the Phase 2 portion of the study were randomized in a 1:1 ratio to receive study treatment of tarextumab along with EP (Arm A) or placebo along with EP (Arm B).
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Highlands Oncology Group, Rogers, Arkansas, United States
Cedars-Sinai Medical Center, Los Angeles, California, United States
Rocky Mountain Cancer Centers, Denver, Colorado, United States
Yale University, New Haven, Connecticut, United States
Georgetown University Hospital, Washington, District of Columbia, United States
Sarah Cannon, Fort Myers, Florida, United States
Ocala Oncology Center, PL, Ocala, Florida, United States
Piedmont Cancer Institute, Atlanta, Georgia, United States
Georgia Cancer Specialists, PC, Atlanta, Georgia, United States
Univeristy of Chicago Medical Center, Chicago, Illinois, United States
Norton Cancer Institute, Louisville, Kentucky, United States
University of Maryland, Greenebaum Cancer Center, Baltimore, Maryland, United States
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland, United States
Weinberg Cancer Institute, Baltimore, Maryland, United States
University of Michigan Medical Center, Clinical Trials Office, Ann Arbor, Michigan, United States
Karmanos Cancer Institute, Detroit, Michigan, United States
Minnesota Oncology Hematology , P.A., Minneapolis, Minnesota, United States
Oncology Hematology West PC, dba Nebraska Cancer Specialists, Omaha, Nebraska, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
Oncology Hematology Care, Inc., Cincinnati, Ohio, United States
Case Western Reserve University, Cleveland, Ohio, United States
Providence Cancer Center Oncology and Hematology Care Eastside, Portland, Oregon, United States
UPMC Cancer Pavilion, Pittsburgh, Pennsylvania, United States
Greenville Health System, Clinical Research Unit, Institute for Translational Oncology Research, Greenville, South Carolina, United States
Tennessee Oncology, PLLC, Chattanooga, Tennessee, United States
The Sarah Cannon Research Institute, Nashville, Tennessee, United States
Texas Oncology-South Austin, Austin, Texas, United States
Texas Oncology-Bedford, Bedford, Texas, United States
Texas Oncology, P.A., Dallas, Texas, United States
The University of Texas MD A nderson Cancer Center, Houston, Texas, United States
Cancer Care Network of South Texas, San Antonio, Texas, United States
Oncology and Hematology Associates of Southwest Virginia Inc., Blacksburg, Virginia, United States
Virginia Cancer Specialists, Fairfax, Virginia, United States
Swedish Cancer Institute, Seattle, Washington, United States
Contact Details
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