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)

Description

The study consists of a Phase1b lead-in portion to determine the MTD of OMP-59R5 in combination with EP for 6 cycles followed a Phase 2, multicenter, 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.

Study Start Date

May 2013

Estimated Completion Date

April 2018

Interventions

  • Drug: Placebo
  • Drug: Cisplatin or Carboplatin
  • Drug: OMP-59R5
  • Drug: Etoposide
  • Drug: Cisplatin

Specialties

  • Pulmonology: Clinical Pharmacology,Lung/Thoracic Oncology
  • Oncology: Lung/Thoracic Oncology,Pharmacology/Therapy

MeSH Terms

  • OMP-59R5
  • Small Cell Lung Carcinoma

Study ID

OncoMed Pharmaceuticals, Inc. -- 59R5-003

Status

Unknown

Trial ID

NCT01859741

Study Type

Interventional

Trial Phase

Phase 1/Phase 2

Enrollment Quota

80

Sponsor

OncoMed Pharmaceuticals, Inc.

Inclusion Criteria

    Subjects must meet all of the following criteria to be eligible for the study: 1. Histologically or cytologically documented extensive stage small cell lung cancer. 2. Adults of 18 years of age or older. 3. Performance Status (ECOG) of 0 or 1. 4. FFPE tumor tissue. 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 or the last EP in the study, whichever is discontinued last. 8. 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.

Exclusion Criteria

    Subjects who meet any of the following criteria will not be eligible for participation in the study: 1. Limited stage small cell lung cancer appropriate for radical treatment with chemoradiation. 2. Prior therapy including radiation, chemotherapy or surgery for newly diagnosed extensive stage small cell lung cancer. 3. 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. 4. 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. 5. A history of malignancy with the exception of: 1. Adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, or in situ cervical cancer 2. Adequately treated stage I cancer from which the subject is currently in remission, or 3. Any other cancer from which the subject has been disease-free for ? 3 years 6. Known human immunodeficiency virus (HIV) infection. 7. Females who are pregnant or breastfeeding. 8. Concurrent use of therapeutic warfarin (prophylactic low dose of warfarin, i.e., 1 mg daily for port catheter is allowed)

Gender

Both

Ages

18 Years to 90 Years

Accepts Healthy Volunteers

No

Study Locations and Contact Information (32)

Study Location Distance Name Phone Email
Yale University - New Haven, Connecticut 18.1 miles Anne Chiang MD PhD 203-785-7411 anne.chiang@yale.edu
Memorial SloanKettering Cancer Center - New York, New York 50.7 miles Amy Quintero 646-888-4357 quintera@mskcc.org
University of Maryland Greenebaum Cancer Center - Baltimore, Maryland 222.5 miles Martin J Edelman MD 410-328-8708 medelman@umm.edu
Georgetown University Hospital - Washington, District of Columbia 258.0 miles Stephen Liu MD 202-444-7935 stephen.v.liu@gunet.georgetown.edu
Virginia Cancer Specialists - Fairfax, Virginia 268.3 miles Noel Swafford 703-208-3174 Noel.Swafford@usoncology.com
Roswell Park Cancer Institute - Buffalo, New York 310.8 miles Karen Hicks 716-845-8947 karen.hicks@roswellpark.org
UPMC Cancer Pavilion - Pittsburgh, Pennsylvania 354.1 miles Mark A Socinski MD 412-623-4083 socinskima@upmc.edu
University Hospitals of Cleveland - Cleveland, Ohio 434.6 miles Afshin Dowlati MD 216-844-5181 afshin.dowlati@uhhospitals.org
Oncology and Hematology Associates of Southwest Virginia Inc - Blacksburg, Virginia 473.1 miles Natasha Holt 540-982-0237 natasha.holt@usoncology.com
Karmanos Cancer Institute - Detroit, Michigan 512.3 miles Shirish Gadgeel MD 313-576-8753 gadgeels@karmanos.org
University of Michigan Medical Center Clinical Trials Office - Ann Arbor, Michigan 545.4 miles Gregory Kalemkerian MD 734-647-8902 kalemker@umich.edu
Oncology Hematology Care Inc - Cincinnati, Ohio 602.2 miles David M Waterhouse MD 513-271-2740 dwaterhouse@ohcmail.com
Greenville Health System Clinical Research Unit Institute for Translational Oncology Research - Greenville, South Carolina 667.6 miles William L Gluck MD 864-232-2820 lgluck@ghs.org
Norton Cancer Institute - Louisville, Kentucky 696.1 miles Erin Davis 502-629-3589 erin.davis@nortonhealthcare.org
Tennessee Oncology PLLC - Chattanooga, Tennessee 781.8 miles Kim Tucker 423-698-1844 ktucker@tnonc.com
Georgia Cancer Specialists PC - Atlanta, Georgia 789.7 miles Kathryn Frank 770-777-1315 kfrank@atlantacancercare.com
Piedmont Cancer Institute - Atlanta, Georgia 800.8 miles Michael Thompson 678-298-3230 mthompson@piedmontcancerinstitute.com
The Sarah Cannon Research Institute - Nashville, Tennessee 810.5 miles David R Spigel MD 615-329-7274 None
Ocala Oncology Center PL - Ocala, Florida 975.8 miles Amy Liebmann MD 352-732-4938 amy.liebmann@usoncology.com
Minnesota Oncology Hematology PA - Minneapolis, Minnesota 1,042.1 miles Lynn W Anderson MD 612-884-6331 lynn.anderson@usoncology.com
Florida Cancer Specialists - Fort Myers, Florida 1,123.1 miles Rachel Piacente 239-274-9930 rpiacente@flcancer.com
Highlands Oncology Group - Rogers, Arkansas 1,173.9 miles Adam Torres 479-878-8130 atorres@hogonc.com
Oncology Hematology West PC dba Nebraska Cancer Specialists - Omaha, Nebraska 1,190.7 miles Megan J Meays 402-691-6971 mmeays@nebraskacancer.com
Texas Oncology PA - Dallas, Texas 1,420.1 miles Rita Lopez 214-370-1846 rita.lopez2@usoncology.com
Texas OncologyBedford - Bedford, Texas 1,437.5 miles Sandy Mathews 817-359-9033 sandy.mathews@usoncology.com
The University of Texas MD A nderson Cancer Center - Houston, Texas 1,475.7 miles Bonnie S Glisson MD 713-792-6363 bglisson@mdanderson.org
Texas OncologySouth Austin - Austin, Texas 1,569.5 miles Deborah Davis 512-421-4234 deborah.davis@usoncology.com
Cancer Care Network of South Texas - San Antonio, Texas 1,626.7 miles Sharon T Wilks MD 210-656-7177 None
Rocky Mountain Cancer Centers - Denver, Colorado 1,665.3 miles Robert M Jotte MD PhD 303-388-4876 None
Swedish Cancer Institute - Seattle, Washington 2,426.6 miles Howard L West MD 206-386-2424 CancerResearch@swedish.org
Providence Cancer Center Oncology and Hematology Care Eastside - Portland, Oregon 2,463.3 miles Brenda Fisher 503-215-2613 brenda.fisher@providence.org
CedarsSinai Medical Center - Los Angeles, California 2,495.4 miles Jonilyn Brown 310-652-3110 jonilyn.brown@cshs.org

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