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)
Status: | Completed |
---|---|
Conditions: | Lung Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - 90 |
Updated: | 4/17/2018 |
Start Date: | May 2013 |
End Date: | May 8, 2017 |
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.
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.
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:
1. Adequate hematologic function (absolute neutrophil count [ANC] ≥ 1,500 cells/μL;
hemoglobin ≥ 9 g/dL, platelets ≥ 100,000/μL).
2. Adequate renal function (serum creatinine ≤ 1.5 mg/dL or calculated creatinine
clearance ≥ 60 mL/min using Cockcroft-Gault formula).
3. 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 >1.5xULN unless it is approved by
the Sponsor's Medical Monitor).
4. Prothrombin Time (PT)/International Normalized Ration (INR) ≤1.5 × ULN, activated
partial thromboplastin time (aPTT) ≤1.5 × ULN.
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)
We found this trial at
36
sites
Denver, Colorado 80218
Principal Investigator: Robert Jotte, MD, PhD
Phone: 303-388-4876
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666 Elm Street
Buffalo, New York 14263
Buffalo, New York 14263
(716) 845-2300

Principal Investigator: Dy, MD
Phone: 716-845-8947
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
Los Angeles, California 90048
(1-800-233-2771)

Principal Investigator: Alain Mita, MD
Phone: 310-652-3110
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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Ann Arbor, Michigan 48109
Principal Investigator: Gregory Kalemkerian, MD
Phone: 734-647-8902
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Atlanta, Georgia 30318
Principal Investigator: Henderson, MD
Phone: 678-298-3230
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Atlanta, Georgia 30341
Principal Investigator: Bordoni, MD
Phone: 770-777-1315
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Austin, Texas 78745
Principal Investigator: James V.H. Uyeki, MD
Phone: 512-421-4234
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Baltimore, Maryland 21231
Principal Investigator: Christine Hann, M.D., Ph.D.
Phone: 410-955-8964
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Baltimore, Maryland 21237
Principal Investigator: Suman Rao, MD
Phone: 443-777-7147
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22 South Greene Street
Baltimore, Maryland 21201
Baltimore, Maryland 21201
410-328-7904

Principal Investigator: Martin J Edelman, MD
Phone: 410-328-8708
University of Maryland Greenebaum Cancer Center The University of Maryland Marlene and Stewart Greenebaum Cancer...
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Bedford, Texas 76022
Principal Investigator: Anderson, MD
Phone: 817-359-9033
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Blacksburg, Virginia 24060
Principal Investigator: Jerome H. Goldschmidt, MD
Phone: 540-982-0237
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Chattanooga, Tennessee 37404
Principal Investigator: Davey B Daniel, MD
Phone: 423-698-1844
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Chicago, Illinois 60637
Principal Investigator: Ravi Salgia, MD, PhD
Phone: 773-702-4399
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5053 Wooster Rd
Cincinnati, Ohio 45226
Cincinnati, Ohio 45226
(513) 751-2273

Principal Investigator: David M Waterhouse, MD
Phone: 513-271-2740
Oncology Hematology Care Our more than 60 physicians and advanced practice providers throughout neighborhood offices...
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10900 Euclid Ave
Cleveland, Ohio 44106
Cleveland, Ohio 44106
216-368-2000

Principal Investigator: Afshin Dowlati, MD
Phone: 216-844-5181
Case Western Reserve Univ Continually ranked among America's best colleges, Case Western Reserve University has...
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Dallas, Texas 75246
Principal Investigator: Karlik Konduri, MD
Phone: 214-370-1846
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Detroit, Michigan 48201
Principal Investigator: SHIRISH GADGEEL, M.D.
Phone: 313-576-8753
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8503 Arlington Blvd., Ste. 400
Fairfax, Virginia 22031
Fairfax, Virginia 22031
(703) 280-5390

Principal Investigator: Alexander I. Spira, MD
Phone: 703-208-3174
Virginia Cancer Specialists, PC Now the world's most advanced cancer treatment capabilities can be found...
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Fort Myers, Florida 33905
Principal Investigator: Lowell L. Hart, M.D.
Phone: 239-274-9930
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Greenville, South Carolina 29605
Principal Investigator: William L Gluck, MD
Phone: 864-232-2820
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Houston, Texas 77030
Principal Investigator: Bonnie S. Glisson, MD
Phone: 713-792-6363
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Louisville, Kentucky 40207
Principal Investigator: Hamm, MD
Phone: 502-629-3589
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Minneapolis, Minnesota 55405
Principal Investigator: Joseph W. Leach, MD
Phone: 612-884-6331
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3322 West End Avenue
Nashville, Tennessee 37203
Nashville, Tennessee 37203
(615)329-SCRI (7274)

Principal Investigator: David Spigel, MD
Phone: 615-329-7274
Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is a global strategic research organization...
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New Haven, Connecticut 6520
(203) 432-4771

Principal Investigator: Anne Chiang, MD PhD
Phone: 203-785-7411
Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...
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Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...
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1275 York Ave
New York, New York 10021
New York, New York 10021
(212) 639-2000

Principal Investigator: Maria C. Pietanza, MD
Phone: 646-888-4357
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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Ocala, Florida 34474
Principal Investigator: Craig H. Reynolds, MD
Phone: 352-732-4938
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Omaha, Nebraska 68130
Principal Investigator: Ralph J. Hauke, MD
Phone: 402-691-6971
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Pittsburgh, Pennsylvania 15232
Principal Investigator: Mark A Socinski, MD
Phone: 412-623-4083
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Portland, Oregon 97213
Principal Investigator: Rachel Sanborn, MD
Phone: 503-215-2613
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Rogers, Arkansas 72758
Principal Investigator: J. Thaddeus Beck, MD
Phone: 479-878-8130
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San Antonio, Texas 78217
Principal Investigator: Sharon T. Wilks, MD
Phone: 210-656-7177
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Seattle, Washington 98104
Principal Investigator: Howard L. West, MD
Phone: 206-386-2424
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3800 Reservoir Rd NW
Washington, District of Columbia 20007
Washington, District of Columbia 20007
(202) 444-2000

Georgetown University Hospital MedStar Georgetown University Hospital is a not-for-profit, acute-care teaching and research hospital...
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