Jazz study for adults suffering from HER2-positive biliary tract cancer
Jazz Pharmaceuticals is sponsoring a clinical study evaluating the safety and efficacy of an investigational medicine called zanidatamab for the treatment of advanced HER2-positive biliary tract cancer. The potential clinical effectiveness of zanidatamab is still being tested and it is not currently approved for treatment of any disease state in any market. The purpose of this page is to inform viewers of the current clinical trial.
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Trial Purpose
The purpose of this study is to compare the efficacy of zanidatamab and CisGem (cisplatin plus gemcitabine) with or without the addition of a programmed death protein 1/ligand 1 (PD-1/L-1) inhibitor versus CisGem with or without a PD-1/L1 inhibitor in adult participants.
What is Biliary Tract Cancer?
Biliary tract cancer is a term that includes cholangiocarcinoma and gall bladder cancer. Cholangiocarcinoma is a type of cancer that originates in the bile ducts. The bile ducts are thin tubes that transport bile from the liver to the small intestine, where it aids in the digestion of fats. Bile is stored in the gall bladder. Biliary tract cancer can occur in any part of the biliary system, including the gall bladder, intrahepatic (inside the liver), perihilar (where the bile ducts exit the liver), and distal (outside the liver) regions.
Biliary tract cancer is relatively rare compared to other types of cancer; it is often not diagnosed until a very advanced stage and can be aggressive and difficult to treat. Common symptoms of biliary tract cancer may include jaundice (yellowing of the skin and eyes), abdominal pain, unexplained weight loss, itching, and changes in stool or urine color.
Are Bile Duct Cancer and Biliary Tract Cancer the same things?
Bile duct cancer is a type of biliary tract cancer also known as cholangiocarcinoma. Cholangiocarcinoma originates in the bile ducts, which are the thin tubes that carry bile from the liver to the small intestine. Biliary cancer is a broader term that encompasses cholangiocarcinoma and gall bladder cancer.
How is Biliary Tract Cancer related to Gallbladder Cancer?
Gallbladder cancer is another malignancy within the biliary system. The gallbladder is a small organ located beneath the liver that stores bile produced by the liver.
Gallbladder cancer specifically refers to malignancies that develop in the tissues of the gallbladder. While it is a distinct type of cancer, gallbladder cancer is a kind of biliary tract cancer.
What is the drug being investigated?
The open-label, randomized phase 3 clinical trial is investigating zanidatamab. Zanidatamab is an investigational medication that works by blocking the HER2 signal in the body while removing the HER2 protein from the cell surface. HER2 signaling tells cancer cells to survive, grow, and multiply. So, blocking this signal and removing HER2 protein from cancer cells may treat tumors. In addition, we are studying zanidatamab’s potential to activate the immune system to attack tumors, which may also help to treat the cancer.
In this trial, zanidatamab is not being studied alone, but in combination with standard treatments for biliary tract cancer.
Information about the study
This biliary tract cancer study will involve approximately 286 participants from around the world. Participants will receive either zanidatamab plus standard of care treatments or standard of care treatment alone. Standard of care treatment include some medications which will only be given for a defined period of time (about 6 months) and others, including zanidatamab, that may be given for as long as it is continuing to help the participant.
Participants in the study will receive the study medicine, as well as study-related visits, tests and assessments, at no cost. Participants can stop taking part in the clinical trial at any time without giving a reason. Caregivers of participants may also be reimbursed for some study-related expenses, such as costs associated with travel and hotel.
Participation in the study is voluntary and participation decisions have no impact on medical care you receive now or in the future.
Frequently Asked Questions
What is a study?
A study (also called a clinical trial) is a medical investigation that helps to answer important questions about an investigational medication, including if the medication works for a certain condition and how safe and tolerable the medication is. All medications must be tested in clinical research studies before they can be approved by regulatory authorities and prescribed to patients.
What is a study?
Why are studies important?
What is the purpose of the study?
Where are the study sites located?
The Study is Taking Place Now!
The study is taking place in the following countries: Argentina, Belgium, Brazil, Canada, Chile, China, Czech Republic, Finland, France, Germany, India, Israel, Italy, Japan, Portugal, Romania, Serbia, S. Korea, Spain, Sweden, Taiwan, Turkey, UK, and USA.
For site location, please contact ClinicalTrialDisclosure@jazzpharma.com or visit clinicaltrials.gov (and search “NCT06282575” or click here).
Additional site and trial information is available for Patients and Healthcare Providers in the United States.
Argentina
Centro Médico Privado CEMAIC
Location: Córdoba, Argentina, X5008HHW
Contact information: clinicaltrialdisclosure@jazzpharma.com
Jujuy Locations:
Fundación ARS Médica
Location: San Salvador De Jujuy, Jujuy, Argentina, 4600
Contact information: clinicaltrialdisclosure@jazzpharma.com
Río Negro Locations:
Centro de Investigaciónes Clínicas – Clínica Viedma
Location: Viedma, Río Negro, Argentina, R8500ACE
Contact information: clinicaltrialdisclosure@jazzpharma.com
Santa Fe Locations:
Hospital Provincial Del Centenario
Location: Rosario, Santa Fe, Argentina, 2000
Contact information: clinicaltrialdisclosure@jazzpharma.com
Instituto Médico de la Fundación Estudios Clínicos
Location: Rosario, Santa Fe, Argentina, S2013DTC
Contact information: clinicaltrialdisclosure@jazzpharma.com
Tucumán Locations:
CAIPO Centro para la Atención Integral del Paciente Oncológico
Location: San Miguel De Tucumán, Tucumán, Argentina, 4000
Contact information: clinicaltrialdisclosure@jazzpharma.com
Belgium
Antwerpen Locations:
Imelda VZW
Location: Bonheiden, Belgium, 2820
Contact information: clinicaltrialdisclosure@jazzpharma.com
UZ Antwerpen
Location: Edegem, Belgium, 2650
Contact information: clinicaltrialdisclosure@jazzpharma.com
Vlaams-Brabant Locations:
UZ Leuven
Location: Leuven, Belgium, 3000
Contact information: clinicaltrialdisclosure@jazzpharma.com
Brazil
Location: Porto Alegre, Brazil, 91350-200
Contact information: clinicaltrialdisclosure@jazzpharma.com
Chile
Araucanía Locations
James Lind Centro de Investigacion del Cancer
Temuco, Araucanía, Chile, 4800827
Libertador Gen Bernardo O Higgins Locations
Location: Rancagua, Libertador Gen Bernardo O Higgins, Chile, 2820000
Servicios Médicos URUMED SpA
Contact information: clinicaltrialdisclosure@jazzpharma.com
Los Lagos Locations
Puerto Montt, Los Lagos, Chile, 5507642
Clinica Puerto Montt
Contact information: clinicaltrialdisclosure@jazzpharma.com
Metropolitana Locations:
Oncovida
Romero Sanchez
Principal Investigator
Location: Santiago, Chile, 7500994
Contact information: clinicaltrialdisclosure@jazzpharma.com
Fundación Arturo López Pérez (FALP)
Caglevic
Principal Investigator
Location: Santiago, Chile, 7500921
Contact information: clinicaltrialdisclosure@jazzpharma.com
Centro de Investigacion y Especialidades Medicas (CDIEM)
Location: Santiago, Región-Metropolitana, Chile, 7500859
Contact information: clinicaltrialdisclosure@jazzpharma.com
Biocinetic Ltda
Location: Santiago, Región-Metropolitana, Chile, 8320000
Contact information: clinicaltrialdisclosure@jazzpharma.com
Czech Republic
Location: Hradec Kralove, Czech Republic, 50005
Contact information: clinicaltrialdisclosure@jazzpharma.com
Fakultni nemocnice v Motole, Onkologicka klinika
Location: Praha 5, Czech Republic, 150 00
Contact information: clinicaltrialdisclosure@jazzpharma.com
France
CHU Brest Hôpital de la Cavale Blanche
Brest, France 29200
Contact information: clinicaltrialdisclosure@jazzpharma.com
CHU de Bordeaux – Hôpital Haut Leveque
Pessac, France 33604
Contact information: clinicaltrialdisclosure@jazzpharma.com
CHU de Toulouse – (Toulouse University Hospital Center)
Toulouse, France 31059
Contact information: clinicaltrialdisclosure@jazzpharma.com
CHU Poitiers
Poitiers, France 86000
Contact information: clinicaltrialdisclosure@jazzpharma.com
CHU Estaing
Clermont-Ferrand, France 63100
Contact information: clinicaltrialdisclosure@jazzpharma.com
CHU Montepellier – Hôpital Saint Eloi
Montpellier, France 34000
Contact information: clinicaltrialdisclosure@jazzpharma.com
Gustave Roussy
Villejuif, France 94805
Contact information: clinicaltrialdisclosure@jazzpharma.com
Hospital Beaujon University
Clichy, France 92110
Contact information: clinicaltrialdisclosure@jazzpharma.com
Hopital Henri Mondor
Créteil, France 94010
Contact information: clinicaltrialdisclosure@jazzpharma.com
Institut de Cancérologie de l’Ouest Saint-Herblain
Cedex, France 44805
Contact information: clinicaltrialdisclosure@jazzpharma.com
Finland
Kuopio University Hospital
Kuopio, Finland 70029
Contact information: clinicaltrialdisclosure@jazzpharma.com
Comprehensive Cancer Center, Helsinki University Hospital
Helsinki, Finland 290
Contact information: clinicaltrialdisclosure@jazzpharma.com
Germany
Charité – Universitätsmedizin Berlin – Campus Virchow Klinikum, Medizinische Klinik mit Schwerpunkt Hamatologie und Tumorimmunologie
Berlin, Germany 13353
clinicaltrialdisclosure@jazzpharma.com
Hessen Locations:
Krankenhaus Nordwest – Institut für Klinisch-Onkologische Forschung (IFK)
Frankfurt, Germany 60488
clinicaltrialdisclosure@jazzpharma.com
Baden-Wuttemberg Locations:
Universitätsklinikum Tübingen – Medizinische Universitätsklinik, Innere Medizin I
Tuebingen, Germany 72076
clinicaltrialdisclosure@jazzpharma.com
Nieder-Sachsen Locations:
Medizinische Hochschule Hannover – Klinik Fur Gastroenterologie, Hepatologie, Infektiologie und Endokrinologie
Hannover, Germany 30625
clinicaltrialdisclosure@jazzpharma.com
Hamburg Locations:
Asklepios Tumorzentrum Hamburg, Asklepios Klinik Altona – Onkologie und Palliativmedizin mit Sektionen Hamatologie und Rheumatologie
Hamburg, Germany 22763
clinicaltrialdisclosure@jazzpharma.com
Schleswig-Holstein Locations:
Universitätsklinikum Schleswig-Holstein – Campus Lübeck, Medizinische Klinik I (MKI)
Lubeck, Germany 23562
clinicaltrialdisclosure@jazzpharma.com
India
Rajiv Gandhi Cancer Institute And Research Centre
New Delhi, India 110085
clinicaltrialdisclosure@jazzpharma.com
Karnataka Locations
KLES Dr Prabhakar Kore Hospital and Medical Research Centre
Belagavi, Karnataka, India 590010
clinicaltrialdisclosure@jazzpharma.com
Maharashtra Locations
Chopda Medicare & Research Centre Pvt. Ltd – Magnum Heart Institute
Nashik, Maharashtra, India, 422005
clinicaltrialdisclosure@jazzpharma.com
Telangana Locations
Pi Health Cancer Hospital
Hyderabad, Telangana, India 500032
clinicaltrialdisclosure@jazzpharma.com
Uttar Pradesh Locations
Mahamana Pandit Madan Mohan Malviya Cancer Centre
Varanasi, Uttar Pradesh, India 221005
clinicaltrialdisclosure@jazzpharma.com
Israel
Rambam Health Care Campus
Principal Investigator: Maria Passhak
Coordinator: Liat Rapaport (Referral coordinator)
Email: O_trials@rambam.health.gov.il
Telephone: +97247776234
Jerusalem, Israel, 91120
The Hadassah University Medical Center, Ein Kerem Hospital
Principal Investigator: Ayala Hubert
Coordinator: Ilana Schoen
Email: ILAMACH@hadassah.org.il
Telephone: 053-8220805
Petah-Tikva, Israel, 49100
Rabin Medical Center, Bellinson Hospital
Principal Investigator: Salomon Stemmer
Coordinator: Michal Cohavi
Email: shmichalco1@clalit.org.il
Telephone: 054-5286262
Ramat Gan, HaMerkaz, Israel, 5265601
The Chaim Sheba Medical Center, Tel Hashomer
Principal Investigator: Dr. Ofer Margalit
Coordinator: Anna Ruth Rapoport
Email: Anna.Rapoport@sheba.health.gov.il
Telephone: +972-35305349
Tel Aviv, Israel, 6423906
Tel Aviv Sourasky Medical Center (Ichilov)
Principal Investigator: Professor Ravit Geva
Coordinator: Itay Eisenkot
Email: Oncologyresearch@tlvmc.gov.il
Telephone: 03-6977362
Italy
Istituto Clinico Humanitas
Rozzano, Italy 20089
clinicaltrialdisclosure@jazzpharma.com
Azienda Ospedaliera Universitaria Integrata Verona
Verona, Italy 37134
clinicaltrialdisclosure@jazzpharma.com
AOU dell’Universit~ degli Studi della Campania Luigi Vanvitelli
Napoli, Italy 80131
clinicaltrialdisclosure@jazzpharma.com
Azienda Ospedaliero Universitaria di Cagliari Presidio Ospedaliero Duilio Casula
Monserrato, Cagliari, Italy 9042
clinicaltrialdisclosure@jazzpharma.com
Azienda Sanitaria Universitaria Friuli Centrale – P.O. S. Maria della Misericordia
Udine Italy, 33100
clinicaltrialdisclosure@jazzpharma.com
Azienda Ospedaliero – Universitaria Pisana
Pisa, Italy 56126
clinicaltrialdisclosure@jazzpharma.com
Fondazione IRCCS Istituto Nazionale per lo studio e la cura dei Tumori
Milano, Italy 20133
clinicaltrialdisclosure@jazzpharma.com
Japan
Chiba Locations:
National Cancer Center Hospital East
Kashiwa, Chiba, Japan 277-8577
clinicaltrialdisclosure@jazzpharma.com
Ehime Locations:
National Hospital Organization Shikoku Cancer Center
Matsuyama-Shi, Ehime, Japan 791-0280
clinicaltrialdisclosure@jazzpharma.com
Fukuoka Locations:
National Hospital Organization Kyushu Cancer Center
Fukuoka-shi, Fukuoka, Japan 811-1395
clinicaltrialdisclosure@jazzpharma.com
Hokkaidô Locations:
Hokkaido University Hospital
Sapporo-Shi, Hokkaidô, Japan 060-8648
clinicaltrialdisclosure@jazzpharma.com
Iasi Locations:
Kyorin University Hospital
Mitaka-shi, Tokyo, Japan 181-8611
clinicaltrialdisclosure@jazzpharma.com
Isikawa Locations:
Kanazawa University Hospital
Kanazawa-shi, Isikawa, Japan 9208641
clinicaltrialdisclosure@jazzpharma.com
Kagoshima Locations:
Kagoshima University Hospital
Kagoshima-shi, Kagoshima, Japan 890-8520
clinicaltrialdisclosure@jazzpharma.com
Mie Locations:
Mie University Hospital
Tsu-Shi, Mie, Japan 514-8507
clinicaltrialdisclosure@jazzpharma.com
Miyagi Locations:
Tohoku University Hospital
Sendai-Shi, Miyagi, Japan 980-8574
clinicaltrialdisclosure@jazzpharma.com
Niigata Locations:
Niigata University Medical and Dental Hospital
Niigata-shi, Niigata, Japan 951-8520
clinicaltrialdisclosure@jazzpharma.com
Ôsaka Locations:
Osaka University Hospital
Suita-Shi, Ôsaka, Japan 565-0871
clinicaltrialdisclosure@jazzpharma.com
Tokyo Locations:
National Cancer Center Hospital
Chuo-Ku, Tokyo, Japan 104-0045
clinicaltrialdisclosure@jazzpharma.com
The Cancer Institute Hospital of Japanese Foundation For Cancer Research
Koto-Ku, Tokyo, Japan 135-8550
clinicaltrialdisclosure@jazzpharma.com
Korea, Republic of
Korea University Anam Hospital
clinicaltrialdisclosure@jazzpharma.com
Seoul, Korea, Republic of, 3080
Seoul National University Hospital
clinicaltrialdisclosure@jazzpharma.com
Seoul, Korea, Republic of, 3722
Severance Hospital, Yonsei University Health System
clinicaltrialdisclosure@jazzpharma.com
Seoul, Korea, Republic of, 4763
Hanyang University Seoul Hospital
clinicaltrialdisclosure@jazzpharma.com
Seoul, Korea, Republic of, 5505
Asan Medical Center
clinicaltrialdisclosure@jazzpharma.com
Seoul, Korea, Republic of, 8308
Korea University Guro Hospital
clinicaltrialdisclosure@jazzpharma.com
Gyeonggi-do Locations
Bundang-Gu, Seongnam-Si, Gyeonggi-do, Korea, Republic of, 13496
CHA Bundang Medical Center, CHA University
clinicaltrialdisclosure@jazzpharma.com
Ilsandong-gu, Goyang-si, Gyeonggi-do, Korea, Republic of, 10408
National Cancer Center
clinicaltrialdisclosure@jazzpharma.com
Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
Seoul National University Bundang Hospital
clinicaltrialdisclosure@jazzpharma.com
Portugal
Unidade Local de Saude de Coimbra, EPE – Hospitais da Universidade de Coimbra
clinicaltrialdisclosure@jazzpharma.com
Porto, Portugal, 4200-072
Instituto Português de Oncologia Do Porto Francisco Gentil, EPE
clinicaltrialdisclosure@jazzpharma.com
Puerto Rico
Puerto Rico Medical Center
Second Floor, Barrio Monacillos
Rio Piedras, Puerto Rico, USA 00935
Karina Arocho-Gonzalez, MD
Principal Investigator
Email:karina.arocho@panoncologytrials.com
Isamar Alicea
Study Coordinator
Email:isamar.alicea@panoncologytrials.com
Phone: +1 787-407-3333
Website: panoncologytrials.com
Romania
Institutul Clinic Fundeni
Bucharest, Romania 22328
clinicaltrialdisclosure@jazzpharma.com
Iasi Locations:
Centrul de Oncologie Euroclinic SRL
Iasi, Iasi, Romania 700106
clinicaltrialdisclosure@jazzpharma.com
Dolj Locations:
Centrul De Oncologie “SF. Nectarie” S.R.L.
Craiova, Dolj, Romania 200542
clinicaltrialdisclosure@jazzpharma.com
Bihor Locations:
Spital Clinic Judetean de Urgenta Bihor
Oradea, Bihor, Romania 410169
clinicaltrialdisclosure@jazzpharma.com
Serbia
Belgrade, Serbia 11040
clinicaltrialdisclosure@jazzpharma.com
South Korea
Spain
Sweden
Malmö, Sweden 205 02
clinicaltrialdisclosure@jazzpharma.com
Taiwan
Kaohsiung, Taiwan 807
clinicaltrialdisclosure@jazzpharma.com
Chang Gung Memorial Hospital Kaohsiung Branch of the Chang Gung Medical Foundation
Kaohsiung, Taiwan 833
clinicaltrialdisclosure@jazzpharma.com
United Kingdom
dinburgh, Scotland EH4 2XU, United Kingdom
clinicaltrialdisclosure@jazzpharma.com
United States
Colorado Locations:
Rocky Mountain Cancer Centers, LLP
Location: Lone Tree, Colorado, US 80124
Contact information: clinicaltrialdisclosure@jazzpharma.com
Florida Locations:
AdventHealth Hematology and Oncology
Location: Orlando, Florida, US 32804
Contact information: clinicaltrialdisclosure@jazzpharma.com
Kentucky Locations:
Norton Cancer Institute
Michael Driscoll, MD
Principal Investigator
Email: GI-NCIResearch@nortonhealthcare.org
Phone: +1 502-629-2500
Massachusetts Locations:
Tufts Medical Center
Location: Boston, Massachusetts, US 2111
Contact information: clinicaltrialdisclosure@jazzpharma.com
Michigan Locations:
Henry Ford Health System
Location: Detroit, Michigan, US 48202
Contact information: clinicaltrialdisclosure@jazzpharma.com
University of Michigan
Vaibhav Sahai
Principal Investigator
UM Cancer Answerline Nurses
Study Coordinator
Email: CancerAnswerLine@med.umich.edu
Phone: +1 800-865-1125
Minnesota Locations:
Minnesota Oncology Hematology, P.A.
Location: Maple Grove, Minnesota, US 55369
Contact information: clinicaltrialdisclosure@jazzpharma.com
New York Locations:
James J. Harding Memorial Sloan Kettering Cancer
James J. Harding, MD
Principal Investigator
Location: New York, New York, US 10022
Phone: +1 332-456-7016
Contact information: clinicaltrialdisclosure@jazzpharma.com
Laura and Isaac Perlmutter Cancer Center at NYU Langone – Ambulatory Care Center
Spencer
Principal Investigator
Location: New York, New York, US 10016
Contact information: clinicaltrialdisclosure@jazzpharma.com
Tennessee Locations:
Sarah Cannon Research Institute (SCRI) Oncology
Meredith Pelster, MD
Principal Investigator
Phone: +1 844-482-4812
Texas Locations:
Texas Oncology – DFW
Location: Dallas, Texas, US 75246
Contact information: clinicaltrialdisclosure@jazzpharma.com
The University of Texas MD Anderson Cancer Center
Location: Houston, Texas, US 77030
Contact information: clinicaltrialdisclosure@jazzpharma.com
South Carolina Locations:
Saint Francis Cancer Center Greenville
Yang
Principal Investigator
Location: South Carolina, US29607
Contact information: clinicaltrialdisclosure@jazzpharma.com