A Phase 1b/2 Study of OMP-59R5 (Tarextumab) in Combination With Etoposide and Platinum Therapy

Stopped early · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Stage IV Small Cell Lung Cancer

In brief

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.

Key facts

Study ID

NCT01859741

Run by

OncoMed Pharmaceuticals, Inc.

People needed

172

Starts

2012-01-07

Expected to finish

2017-05-08

Last updated by the study team

2020-09-09

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects must meet all of the following criteria to be eligible for the study:
• Histologically or cytologically documented extensive stage small cell lung cancer.
• Adults of 18 years of age or older.
• Performance Status (ECOG) of 0 or 1.
• Formalin Fixed Paraffin Embedded (FFPE) tumor tissue.
• Adequate organ function:
• Adequate hematologic function (absolute neutrophil count [ANC] ≥ 1,500 cells/μL; hemoglobin ≥ 9 g/dL, platelets ≥ 100,000/μL).
• Adequate renal function (serum creatinine ≤ 1.5 mg/dL or calculated creatinine clearance ≥ 60 mL/min using Cockcroft-Gault formula).
• Adequate hepatic function (alanine aminotransferase [ALT] ≤ 3 x upper limit of normal [ULN], ALT may be ≤ 5 x ULN if due to liver metastases but cannot be associated with concurrent elevated bilirubin >1.5 times the upper limit of normal (ULN) unless it is approved by the Sponsor's Medical Monitor).
• Prothrombin Time (PT)/International Normalized Ration (INR) ≤1.5 × ULN, activated partial thromboplastin time (aPTT) ≤1.5 × ULN.
• Written consent on an Institutional Review Board (IRB)/IndependentEthics Committee (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 or the last EP in the study, whichever is discontinued last.
• Male subjects must be surgically sterile or must agree to use physician-approved contraception during the study and for 30 days following the last study drug administration or the last EP in the study, whichever is discontinued last.

You may not qualify if…

• Subjects who meet any of the following criteria will not be eligible for participation in the study:
• Limited stage small cell lung cancer appropriate for radical treatment with chemoradiation.
• Prior therapy including radiation, chemotherapy or surgery for newly diagnosed extensive stage small cell lung cancer.
• Presence of any serious or uncontrolled illness including, but not limited to: ongoing or active infection, symptomatic congestive heart failure unstable angina pectoris, uncontrolled cardiac arrhythmia, uncontrolled arterial thrombosis, symptomatic pulmonary embolism, and psychiatric illness that would limit compliance with study requirement.
• History of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty and/or stenting within 6 months prior to the first administration of study drug.
• A history of malignancy with the exception of:
• Adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, or in situ cervical cancer
• Adequately treated stage I cancer from which the subject is currently in remission, or
• Any other cancer from which the subject has been disease-free for ≥ 3 years
• Known human immunodeficiency virus (HIV) infection.
• Females who are pregnant or breastfeeding.
• Concurrent use of therapeutic warfarin (prophylactic low dose of warfarin, i.e., 1 mg daily for port catheter is allowed)

Where it is running

• 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 D.C., 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

Full record on ClinicalTrials.gov

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