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

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

263

Participants

Timeline

Start Date

December 1, 2015

Primary Completion Date

August 20, 2021

Study Completion Date

August 20, 2021

Conditions
Metastatic Renal Cell CarcinomaAdvanced Urothelial CarcinomaAdvanced Gastric AdenocarcinomaMetastatic Colorectal Adenocarcinoma
Interventions
DRUG

ibrutinib

Ibrutinib administered orally once daily with 8 ounces (approximately 240 mL) of water.

DRUG

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.

DRUG

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.

DRUG

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.

DRUG

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.

DRUG

pembrolizumab

Pembrolizumab 200 mg intravenous (IV) every 3 weeks.

Trial Locations (65)

13620

Seoul National University Bundang Hospital /ID# 1128-0982, Seongnam

19104

Abramson Cancer Center of the Univ. of Pennsylvania /ID# 1128-0402, Philadelphia

20007

Georgetown University Hospital /ID# 1128-0824, Washington D.C.

22031

Duplicate_Virginia Cancer Specialists - Fairfax Office /ID# 1128-0972, Fairfax

27157

Wake Forest Univ HS /ID# 1128-0975, Winston-Salem

28034

Hospital Universitario Ramon y Cajal /ID# 1128-0874, Madrid

28041

Hospital Universitario 12 de Octubre /ID# 1128-0864, Madrid

28046

Hospital Universitario La Paz /ID# 1128-0921, Madrid

32207

Duplicate_Cancer Specialist of North Florida (CSNF) ( R ) /ID# 1128-1093, Jacksonville

35805

Clearview Cancer Institute /ID# 1128-0965, Huntsville

37232

Vanderbilt Infectious Disease Clinic /ID# 1128-0024, Nashville

39008

Hospital Unversitario Marques de Valdecilla /ID# 1128-0973, Santander

41013

Hospital Universitario Virgen del Rocio /ID# 1128-0863, Seville

46237

Franciscan Health Indianapolis /ID# 1128-1125, Indianapolis

47905

Horizon Oncology Research Center /ID# 1128-0337, Lafayette

48201

Barbara Ann Karmanos Cancer In /ID# 1128-0130, Detroit

48202

Henry Ford Hospital /ID# 1128-0195, Detroit

52242

University of Iowa Hospitals and Clinics /ID# 1128-0766, Iowa City

58128

Chonnam National University Hwasun Hospital /ID# 1128-0916, Jeonnam

60201

Northshore Kellogg Cancer Center /ID# 1128-0484, Evanston

65102

Capital Region Medical Center /ID# 1128-1412, Jefferson City

65613

Central Care Cancer Center /ID# 1128-1596, Bolivar

66205

The University of Kansas Cancer Center /ID# 1128-0706, Fairway

68114

Nebraska Methodist Hospital /ID# 1128-0229, Omaha

70006

East Jefferson General Hospital /ID# 1128-1084, Metairie

76508

Duplicate_Scott & White Mem Hosp & Clin /ID# 1128-0046, Temple

85234

Banner MD Anderson Cancer Center /ID# 1128-0802, Gilbert

85724

University of Arizona Cancer Center - Tucson /ID# 1128-1546, Tucson

87106

Duplicate_New Mexico Cancer Care Alliance /ID# 1128-0938, Albuquerque

87401

San Juan Oncology Associates /ID# 1128-1020, Farmington

90033

USC Norris Cancer Center /ID# 1128-0209, Los Angeles

90404

Premiere Oncology, A Medical Corporation /ID# 1128-1085, Santa Monica

93901

Salinas Valley Memorial Hosp /ID# 1128-0482, Salinas

94015

St Marys Medical Center /ID# 1128-0969, Daly City

94574

Gregory Smith, MD (Private Practice) /ID# 1128-0419, St. Helena

94704

Alta Bates Comprehensive Cancer Center /ID# 1128-0135, Berkeley

95403

St. Joseph Health /ID# 1128-1462, Santa Rosa

98101

Virginia Mason Medical Center /ID# 1128-0005, Seattle

98109

University of Washington /ID# 1128-1382, Seattle

98801

Confluence Health /ID# 1128-0894, Wenatchee

92037-0845

Duplicate_University of California San Diego/ Moores Cancer Center /ID# 1128-0241, La Jolla

90822-5201

VA Long Beach Healthcare System /ID# 1128-0480, Long Beach

92868-3201

UC Irvine Medical Center - Chao Family Comprehensive Cancer Center /ID# 1128-0008, Orange

06856-3852

Whittingham Cancer Center at Norwalk Hospital /ID# 1128-0411, Norwalk

31904-8946

IACT Health-Columbus /ID# 1128-1389, Columbus

02111-1552

Duplicate_Tufts Medical Center /ID# 1128-0016, Boston

08724

New Jersey Center for Cancer Research /ID# 1128-0493, Brick

10065-6007

Memorial Sloan Kettering Cancer Center-Koch Center /ID# 1128-0091, New York

97239-3011

Oregon Health & Science University /ID# 1128-0251, Portland

17033-2360

Penn State Hershey Medical Ctr /ID# 1128-0220, Hershey

77555-0565

The University of Texas Medical Branch (UTMB) - Cancer Center - Galves /ID# 1128-0974, Galveston

03722

Yonsei University Health System Severance Hospital /ID# 1128-0927, Seoul

03080

Seoul National University Hospital /ID# 1128-0926, Seoul

05505

Asan Medical Center /ID# 1128-0963, Seoul

06351

Samsung Medical Center /ID# 1128-0925, Seoul

06591

The Catholic University of Korea, Seoul St. Mary's Hospital /ID# 1128-0928, Seoul

08308

Korea University Guro Hospital /ID# 1128-0924, Seoul

08916

Instituto Catalan de Oncologia (ICO) Badalona /ID# 1128-0984, Badalona

08035

Hospital Universitario Vall d'Hebron /ID# 1128-0534, Barcelona

08036

Hospital Clinic de Barcelona /ID# 1128-0533, Barcelona

W1G 6AD

Sarah Cannon Research Institute /ID# 1128-1079, London

G12 0YN

Duplicate_Beatson west of scotland cancer center /ID# 1128-0652, Glasgow

SW3 6JJ

The Royal Marsden NHS Foundation Trust /ID# 1128-0543, London

M20 4BX

The Christie Hospital /ID# 1128-0030, Manchester

OX3 7LE

Duplicate_Oxford University Hospitals NHS Trust /ID# 1128-0814, Oxford

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pharmacyclics LLC.

INDUSTRY