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
Chile
Araucanía Locations
Temuco, Araucanía, Chile, 4800827
James Lind Centro de Investigacion del Cancer
Libertador Gen Bernardo O Higgins Locations
Rancagua, Libertador Gen Bernardo O Higgins, Chile, 2820000
Servicios Médicos URUMED SpA
clinicaltrialdisclosure@jazzpharma.com
Los Lagos Locations
Puerto Montt, Los Lagos, Chile, 5507642
Clinica Puerto Montt
clinicaltrialdisclosure@jazzpharma.com
Región-Metropolitana Locations
Santiago, Región-Metropolitana, Chile, 7500859
Centro de Investigacion y Especialidades Medicas (CDIEM)
clinicaltrialdisclosure@jazzpharma.com
Santiago, Región-Metropolitana, Chile, 8320000
Biocinetic Ltda
clinicaltrialdisclosure@jazzpharma.com
India
New Delhi, India, 110085
Rajiv Gandhi Cancer Institute And Research Centre
clinicaltrialdisclosure@jazzpharma.com
Karnataka Locations
Belagavi, Karnataka, India, 590010
KLES Dr Prabhakar Kore Hospital and Medical Research Centre
clinicaltrialdisclosure@jazzpharma.com
Maharashtra Locations
Nashik, Maharashtra, India, 422005
Chopda Medicare & Research Centre Pvt. Ltd – Magnum Heart Institute
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
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
Spain
Taiwan
Kaohsiung Medical University – Chung-Ho Memorial Hospital
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
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
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