Study to Evaluate Ibrutinib Combination Therapy in Patients With Selected Gastrointestinal and Genitourinary Tumors
NCT ID: NCT02599324
Last Updated: 2023-11-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
263 participants
INTERVENTIONAL
2015-12-01
2021-08-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort 1: Renal Cell Carcinoma (RCC)
Phase 1b: Participants receive ibrutinib at various dose levels in combination with a fixed dose of everolimus to determine the recommended phase 2 dose (RP2D) of ibrutinib. (The RP2D was determined for each cohort separately.)
Phase 2: Participants receive ibrutinib at the RP2D determined in phase 1b in combination with everolimus.
ibrutinib
Ibrutinib administered orally once daily with 8 ounces (approximately 240 mL) of water.
everolimus
Everolimus 10 mg tablets should be taken orally once daily at the same time every day, either consistently with food or consistently without food. Four (4) x 2.5 mg tablets or two (2) x 5.0 mg tablets may be substituted if 10 mg tablet strength is not available.
Cohort 2: Urothelial Carcinoma (UC)
Phase 1b: Participants receive ibrutinib at various dose levels in combination with a fixed dose of paclitaxel to determine the RP2D of ibrutinib. (The RP2D was determined for each cohort separately.)
Phase 2: Participants receive ibrutinib at the RP2D determined in Phase 1b in combination with paclitaxel.
ibrutinib
Ibrutinib administered orally once daily with 8 ounces (approximately 240 mL) of water.
paclitaxel
Paclitaxel should be administered as a 60-minute (±10 minutes) infusion. Paclitaxel should be given at a dose level of 80 mg/m\^2, once weekly, in continual 3 weekly cycles.
Cohort 3: Gastric Adenocarcinoma (GA or GC)
Phase 1b: Participants receive ibrutinib at various dose levels in combination with a fixed dose of docetaxel to determine the RP2D of ibrutinib. (The RP2D was determined for each cohort separately.)
Phase 2: Participants receive docetaxel at the RP2D determined in Phase 1b in combination with docetaxel.
ibrutinib
Ibrutinib administered orally once daily with 8 ounces (approximately 240 mL) of water.
docetaxel
Docetaxel administered as a 60 minute infusion (±10 minutes) at a dose level of 60 - 75 mg/m\^2 (according to local institutional standard of care), given continually in 21-day cycles.
Cohort 4: Colorectal Adenocarcinoma (CRC)
Phase 1b: Participants receive ibrutinib at various dose levels in combination with a fixed dose of cetuximab to determine RP2D of ibrutinib. (The RP2D was determined for each cohort separately.)
Phase 2: Participants receive ibrutinib at the RP2D determined in Phase 1b in combination with cetuximab.
ibrutinib
Ibrutinib administered orally once daily with 8 ounces (approximately 240 mL) of water.
cetuximab
Cetuximab 400 mg/m\^2 administered as a 120-minute IV infusion. The recommended subsequent weekly dose (all other infusions) is 250 mg/m\^2 infused over 60 minutes.
Cohort 5: Urothelial Carcinoma (UC) Ibrutinib
Phase 1b: Participants receive ibrutinib at various dose levels to determine the RP2D of ibrutinib.(The RP2D was determined for each cohort separately.)
Phase 2: Participants receive ibrutinib at the RP2D determined in Phase 1b.
ibrutinib
Ibrutinib administered orally once daily with 8 ounces (approximately 240 mL) of water.
Cohort 6: Urothelial Carcinoma (UC) With Pembrolizumab
Phase 1b: Participants receive ibrutinib at various dose levels in combination with a fixed dose of pembrolizumab to determine the RP2D of ibrutinib. (The RP2D was determined for each cohort separately.)
Phase 2: Participants receive ibrutinib at the RP2D determined in Phase 1b in combination with pembrolizumab.
ibrutinib
Ibrutinib administered orally once daily with 8 ounces (approximately 240 mL) of water.
pembrolizumab
Pembrolizumab 200 mg intravenous (IV) every 3 weeks.
Interventions
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ibrutinib
Ibrutinib administered orally once daily with 8 ounces (approximately 240 mL) of water.
everolimus
Everolimus 10 mg tablets should be taken orally once daily at the same time every day, either consistently with food or consistently without food. Four (4) x 2.5 mg tablets or two (2) x 5.0 mg tablets may be substituted if 10 mg tablet strength is not available.
paclitaxel
Paclitaxel should be administered as a 60-minute (±10 minutes) infusion. Paclitaxel should be given at a dose level of 80 mg/m\^2, once weekly, in continual 3 weekly cycles.
docetaxel
Docetaxel administered as a 60 minute infusion (±10 minutes) at a dose level of 60 - 75 mg/m\^2 (according to local institutional standard of care), given continually in 21-day cycles.
cetuximab
Cetuximab 400 mg/m\^2 administered as a 120-minute IV infusion. The recommended subsequent weekly dose (all other infusions) is 250 mg/m\^2 infused over 60 minutes.
pembrolizumab
Pembrolizumab 200 mg intravenous (IV) every 3 weeks.
Eligibility Criteria
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Inclusion Criteria
For UC cohort 6:
Locally advanced or mUC who are not eligible for cisplatin chemo with a PDL-1 score (CPS) of ≥ 10 without prior treatment.
Locally advanced or mUC who have progressed on platinum chemo or within 12 months of neo- or adjuvant therapy with a platinum chemotherapy. A minimum of 1 and maximum of 2 prior therapies.
For cohort 3 gastric or GEJ adenocarcinoma: minimum of 1 and maximum of 3 prior regimens one of which must have included a fluoropyrimidine regimen For cohort 4 CRC: minimum of 2 and maximum of 4 prior regimens, which must have included both an irinotecan and an oxaliplatin based regimen unless unable to tolerate irinotecan chemotherapy
Laboratory:
Adequate hematologic function:
Absolute neutrophil count ≥1500 cells/mm3 (1.5 x 109/L) Platelet count \>80,000 cells/mm3 (80 x 109/L) for cohort 1 (RCC) Platelet counts \>100,000 cells/mm3 (100 x 109/L) for all UC cohorts Hemoglobin ≥8.0 g/dL. for cohort 1 (RCC),all UC cohorts, and cohort 3 (GC) Hemoglobin ≥9.0 g/dL for cohort 4 (CRC)
Adequate hepatic and renal function defined as:
Serum aspartate transaminase (AST) and/or alanine transaminase (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) with the exception of subjects in the GC cohort where docetaxel is administered, these subjects must have bilirubin within normal limits (WNL) Estimated Creatinine Clearance ≥30 mL/min (Cockcroft-Gault)
Exclusion Criteria
Everolimus or temsirolimus (RCC cohort 1) Any taxane (UC cohort of ibrutinib + paclitaxel) (cohort 2) Checkpoint inhibitors (UC cohort 6) Any taxane (GC cohort 3) Cetuximab or panitumumab (CRC cohort 4)
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
UC cohort 6 only:
Subjects who have an active, known or suspected autoimmune disease. Evidence of clinically significant interstitial lung disease or active, noninfectious pneumonitis.
Non-steroid immunosuppressive medications within 14 days before the first dose of ibrutinib and pembrolizumab.
Subjects in whom prior anti PD-1 / anti-PD-L1 therapy was intolerable and required discontinuation of treatment.
18 Years
ALL
No
Sponsors
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Pharmacyclics LLC.
INDUSTRY
Responsible Party
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Principal Investigators
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Pharmacyclics LLC
Role: STUDY_DIRECTOR
Pharmacyclics LLC.
Locations
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Clearview Cancer Institute /ID# 1128-0965
Huntsville, Alabama, United States
Banner MD Anderson Cancer Center /ID# 1128-0802
Gilbert, Arizona, United States
University of Arizona Cancer Center - Tucson /ID# 1128-1546
Tucson, Arizona, United States
Alta Bates Comprehensive Cancer Center /ID# 1128-0135
Berkeley, California, United States
St Marys Medical Center /ID# 1128-0969
Daly City, California, United States
Duplicate_University of California San Diego/ Moores Cancer Center /ID# 1128-0241
La Jolla, California, United States
VA Long Beach Healthcare System /ID# 1128-0480
Long Beach, California, United States
USC Norris Cancer Center /ID# 1128-0209
Los Angeles, California, United States
UC Irvine Medical Center - Chao Family Comprehensive Cancer Center /ID# 1128-0008
Orange, California, United States
Salinas Valley Memorial Hosp /ID# 1128-0482
Salinas, California, United States
Premiere Oncology, A Medical Corporation /ID# 1128-1085
Santa Monica, California, United States
St. Joseph Health /ID# 1128-1462
Santa Rosa, California, United States
Gregory Smith, MD (Private Practice) /ID# 1128-0419
St. Helena, California, United States
Whittingham Cancer Center at Norwalk Hospital /ID# 1128-0411
Norwalk, Connecticut, United States
Georgetown University Hospital /ID# 1128-0824
Washington D.C., District of Columbia, United States
Duplicate_Cancer Specialist of North Florida (CSNF) ( R ) /ID# 1128-1093
Jacksonville, Florida, United States
IACT Health-Columbus /ID# 1128-1389
Columbus, Georgia, United States
Northshore Kellogg Cancer Center /ID# 1128-0484
Evanston, Illinois, United States
Franciscan Health Indianapolis /ID# 1128-1125
Indianapolis, Indiana, United States
Horizon Oncology Research Center /ID# 1128-0337
Lafayette, Indiana, United States
University of Iowa Hospitals and Clinics /ID# 1128-0766
Iowa City, Iowa, United States
The University of Kansas Cancer Center /ID# 1128-0706
Fairway, Kansas, United States
East Jefferson General Hospital /ID# 1128-1084
Metairie, Louisiana, United States
Duplicate_Tufts Medical Center /ID# 1128-0016
Boston, Massachusetts, United States
Barbara Ann Karmanos Cancer In /ID# 1128-0130
Detroit, Michigan, United States
Henry Ford Hospital /ID# 1128-0195
Detroit, Michigan, United States
Central Care Cancer Center /ID# 1128-1596
Bolivar, Missouri, United States
Capital Region Medical Center /ID# 1128-1412
Jefferson City, Missouri, United States
Nebraska Methodist Hospital /ID# 1128-0229
Omaha, Nebraska, United States
New Jersey Center for Cancer Research /ID# 1128-0493
Brick, New Jersey, United States
Duplicate_New Mexico Cancer Care Alliance /ID# 1128-0938
Albuquerque, New Mexico, United States
San Juan Oncology Associates /ID# 1128-1020
Farmington, New Mexico, United States
Memorial Sloan Kettering Cancer Center-Koch Center /ID# 1128-0091
New York, New York, United States
Wake Forest Univ HS /ID# 1128-0975
Winston-Salem, North Carolina, United States
Oregon Health & Science University /ID# 1128-0251
Portland, Oregon, United States
Penn State Hershey Medical Ctr /ID# 1128-0220
Hershey, Pennsylvania, United States
Abramson Cancer Center of the Univ. of Pennsylvania /ID# 1128-0402
Philadelphia, Pennsylvania, United States
Vanderbilt Infectious Disease Clinic /ID# 1128-0024
Nashville, Tennessee, United States
The University of Texas Medical Branch (UTMB) - Cancer Center - Galves /ID# 1128-0974
Galveston, Texas, United States
Duplicate_Scott & White Mem Hosp & Clin /ID# 1128-0046
Temple, Texas, United States
Duplicate_Virginia Cancer Specialists - Fairfax Office /ID# 1128-0972
Fairfax, Virginia, United States
Virginia Mason Medical Center /ID# 1128-0005
Seattle, Washington, United States
University of Washington /ID# 1128-1382
Seattle, Washington, United States
Confluence Health /ID# 1128-0894
Wenatchee, Washington, United States
Seoul National University Bundang Hospital /ID# 1128-0982
Seongnam, Gyeonggido, South Korea
Yonsei University Health System Severance Hospital /ID# 1128-0927
Seoul, Seoul Teugbyeolsi, South Korea
Chonnam National University Hwasun Hospital /ID# 1128-0916
Jeonnam, , South Korea
Seoul National University Hospital /ID# 1128-0926
Seoul, , South Korea
Asan Medical Center /ID# 1128-0963
Seoul, , South Korea
Samsung Medical Center /ID# 1128-0925
Seoul, , South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital /ID# 1128-0928
Seoul, , South Korea
Korea University Guro Hospital /ID# 1128-0924
Seoul, , South Korea
Instituto Catalan de Oncologia (ICO) Badalona /ID# 1128-0984
Badalona, Barcelona, Spain
Hospital Unversitario Marques de Valdecilla /ID# 1128-0973
Santander, Cantabria, Spain
Hospital Universitario Vall d'Hebron /ID# 1128-0534
Barcelona, , Spain
Hospital Clinic de Barcelona /ID# 1128-0533
Barcelona, , Spain
Hospital Universitario Ramon y Cajal /ID# 1128-0874
Madrid, , Spain
Hospital Universitario 12 de Octubre /ID# 1128-0864
Madrid, , Spain
Hospital Universitario La Paz /ID# 1128-0921
Madrid, , Spain
Hospital Universitario Virgen del Rocio /ID# 1128-0863
Seville, , Spain
Sarah Cannon Research Institute /ID# 1128-1079
London, England, United Kingdom
Duplicate_Beatson west of scotland cancer center /ID# 1128-0652
Glasgow, Scotland, United Kingdom
The Royal Marsden NHS Foundation Trust /ID# 1128-0543
London, , United Kingdom
The Christie Hospital /ID# 1128-0030
Manchester, , United Kingdom
Duplicate_Oxford University Hospitals NHS Trust /ID# 1128-0814
Oxford, , United Kingdom
Countries
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References
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Oh DY, Maqueda MA, Quinn DI, O'Dwyer PJ, Chau I, Kim SY, Duran I, Castellano D, Berlin J, Mellado B, Williamson SK, Lee KW, Marti F, Mathew P, Saif MW, Wang D, Chong E, Hilger-Rolfe J, Dean JP, Arkenau HT. Ibrutinib combination therapy for advanced gastrointestinal and genitourinary tumours: results from a phase 1b/2 study. BMC Cancer. 2023 Nov 3;23(1):1056. doi: 10.1186/s12885-023-11539-1.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2015-003656-40
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
PCYC-1128-CA
Identifier Type: -
Identifier Source: org_study_id
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