A Study to Evaluate Ibrutinib Combination Therapy in Patients With Selected Gastrointestinal and Genitourinary Tumors



Status:Recruiting
Conditions:Prostate Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:8/11/2018
Start Date:November 2015
End Date:June 2019
Contact:Bhagyashree Yadav
Email:byadav@pcyc.com
Phone:669-224-1104

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A Phase 1b/2 Study of Ibrutinib Combination Therapy in Selected Advanced Gastrointestinal And Genitourinary Tumors

The purpose of this study is to evaluate the safety, tolerability, and efficacy of the
combination treatment of ibrutinib with everolimus, paclitaxel, docetaxel, or cetuximab in
selected advanced gastrointestinal and genitourinary tumors.


Inclusion Criteria:

- RCC (clear cell), urothelial carcinoma (transitional cell), gastric or
gastro-esophageal junctional (GEJ) adenocarcinoma, or K-RAS or N-RAS wild-type EGFR
expressing CRC

- For RCC:

- previously received at least 1 but no more than 4 lines of therapy, one therapy
must have included a VEGF TKI

- ECOG performance status of 0-1 (score of 2 may be acceptable)

- For urothelial carcinoma:

- previously received at least 1 but no more than 2 lines of therapy, one therapy
must have included a platinum based regimen

- ECOG performance status of 0-1

- For gastric or GEJ adenocarcinoma:

- previously received at least 1 but no more than 3 lines of therapy, one therapy
must have included a fluoropyrimidine based regimen

- ECOG performance status of 0-1

- For CRC:

- previously received at least 2 but no more than 4 lines of therapy, which must
have included both an irinotecan and an oxaliplatin based regimen

- ECOG performance status of 0-1 (score of 2 may be acceptable)

- For all cohorts:

- Adequate hematologic function:

- Absolute neutrophil count (ANC) >1500 cells/mm3

- For RCC, platelet count ≥80,000 cells/mm3

- For urothelial carcinoma, gastric or GEJ adenocarcinoma, and CRC, platelet
count ≥100,000 cells/mm3

- For RCC, urothelial carcinoma, and gastric or GEJ adenocarcinoma, hemoglobin
≥8.0 g/dL

- For CRC, hemoglobin ≥9.0 g/dL

- Adequate hepatic and renal function defined as:

- AST and/or ALT ≤5.0 x upper limit of normal (ULN) if liver metastases, or ≤3
x ULN without liver metastases

- Alkaline phosphatase <3.0 x ULN or ≤5.0 x ULN if liver or bone metastases
present

- Bilirubin ≤1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or
of non-hepatic origin, such as hemolysis)

- Estimated Creatinine Clearance ≥30 mL/min

Exclusion Criteria:

- For RCC, prior treatment with everolimus or temsirolimus

- For urothelial carcinoma, prior treatment with any taxane

- For gastric or GEJ adenocarcinoma, prior treatment with any taxane

- For CRC, prior treatment with cetuximab or panitumumab

- For all cohorts:

- concomitant use of warfarin or other Vitamin K antagonists

- history of stroke or intracranial hemorrhage within 6 months prior to enrollment

- major surgery within 4 weeks of first dose of study drug

- requires treatment with strong CYP3A inhibitors

- known bleeding disorders or hemophilia
We found this trial at
26
sites
3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Principal Investigator: Peter O'Dwyer, MD
Phone: 215-662-7487
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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800 Washington St
Boston, Massachusetts 02111
(617) 636-5000
Principal Investigator: Wasif W Saif, MD
Phone: 617-636-2883
Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
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Boston, MA
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Los Angeles, California 90033
213) 740-2311
Principal Investigator: David Quinn, MD, PhD
Phone: 323-865-0802
University of Southern California The University of Southern California is one of the world’s leading...
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Los Angeles, CA
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2220 Pierce Ave
Nashville, Tennessee 37232
615-936-8422
Principal Investigator: Jordan D Berlin, MD
Phone: 615-322-4967
Vanderbilt-Ingram Cancer Center The Vanderbilt-Ingram Cancer Center, located in Nashville, Tenn., brings together the clinical...
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Principal Investigator: Matthew Taylor, MD
Phone: 503-418-9324
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Portland, OR
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2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
Principal Investigator: Ding Wang, MD
Phone: 313-916-3721
Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
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Detroit, MI
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Detroit, Michigan 48201
Principal Investigator: Ulka Vaishampayan, MD
Phone: 313-576-9371
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Detroit, MI
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8503 Arlington Blvd., Ste. 400
Fairfax, Virginia 22031
(703) 280-5390
Principal Investigator: Alex Spira, MD
Phone: 703-280-5390
Virginia Cancer Specialists, PC Now the world's most advanced cancer treatment capabilities can be found...
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Fairway, KS
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Farmington, New Mexico 87401
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Galveston, Texas 77555
Principal Investigator: Avi Markowitz, MD
Phone: 409-772-0575
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Hershey, Pennsylvania 17033
Principal Investigator: Nelson Yee, MD
Phone: 717-531-0003
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Hershey, PA
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Huntsville, Alabama 35805
Principal Investigator: Paul S Dang, MD
Phone: 256-705-4283
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Hwasun, Jeollanam-do 58128
Principal Investigator: Ik Joo Chung
Phone: 82-61-379-8015
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Jacksonville, Florida 32256
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3855 Health Sciences Dr,
La Jolla, California 92093
(858) 822-6100
Principal Investigator: James M Randall, MD
Phone: 858-822-2268
UC San Diego Moores Cancer Center Established in 1978, UC San Diego Moores Cancer Center...
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La Jolla, CA
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Lafayette, Indiana
Principal Investigator: Wael Harb, MD
Phone: 765-446-5111
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Lafayette, IN
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Metairie, Louisiana 70006
Principal Investigator: Thomas Cosgriff, MD
Phone: 504-503-5368
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Norwalk, CT
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8303 Dodge Street
Omaha, Nebraska 68114
(402) 354–4000
Principal Investigator: Ralph Hauke, MD
Phone: 402-354-7938
Nebraska Methodist Hospital Methodist Hospital is a general medical and surgical hospital in Omaha, NE....
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San Francisco, California 84117
Principal Investigator: Robert W Weber, MD
Phone: 415-750-4060
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Santa Monica, California 90404
Principal Investigator: Lee Rosen, MA
Phone: 310-633-8411
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Santa Monica, CA
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2401 S. 31st Street
Temple, Texas 76508
254-724-2111
Principal Investigator: Lucas Wong, MD
Phone: 254-724-3796
Scott & White Memorial Hospital When Arthur C. Scott, MD, and Raleigh R. White Jr.,...
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3800 Reservoir Rd NW
Washington, District of Columbia 20007
(202) 687-7695
Principal Investigator: Michael Pishvaian, MD, PhD
Phone: 202-687-8974
Georgetown University Medical Center Georgetown University Medical Center is committed to excellence in research, education...
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Wenatchee, Washington 98801
Principal Investigator: Lindsay Overton, MD
Phone: 509-664-4868
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Winston-Salem, North Carolina 27157
Principal Investigator: Boris Pasche, MD
Phone: 336-716-6914
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