Clinical Trials

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It is not the intention of the Cholangiocarcinoma Foundation to provide specific medical advice.  We provide website users with information to help them better understand their health conditions and the current approaches related to prevention, diagnosis, treatment and supportive care. You are urged to always seek the advice of your physician or other qualified healthcare provider.

Phase II study of copanlisib (BAY 80-6946) in combination with gemcitabine and cisplatin in advanced cholangiocarcinoma

Study Name   Phase II study of copanlisib (BAY 80-6946) in combination with gemcitabine and cisplatin in advanced cholangiocarcinoma Study Center Institution Name   Moffitt Cancer Center Institution Address   12902 Magnolia Drive City   Tampa State   Florida Zip Code   33612 Study Contacts Principal Investigator   Richard Kim, MD P.I. Phone   (813) 745-1277 P.I. Email   richard.kim@moffitt.org Study Coordinator   Fatima Tariq Study Coordinator Phone   (813) 745-1277 Study Coordinator Email   fatima.tariq@moffitt.org OVERVIEW – in layman’s terms (150 words max)   This is a study for patients with advanced cholangiocarcinoma or gallbladder cancer. It includes chemotherapy (gemcitabine and cisplatin) with the addition of a PI3K inhibitor to try to improve outcome for this group of patients Enrollment   25 Study... read more

A Phase II Study of Nivolumab in Patients with Advanced Refractory Biliary Cancers

Study Name   A Phase II Study of Nivolumab in Patients with Advanced Refractory Biliary Cancers Study Center Institution Name   Moffitt Cancer Center Institution Address   12902 Magnolia Drive City   Tampa State   Florida Zip Code   33606 Website   https://www.moffitt.org Study Contacts Principal Investigator   Nishi Kothari, MD P.I. Phone   (813) 745-7229 P.I. Email   nishi.kothari@moffitt.org Study Coordinator   Marjorie Brelsford Study Coordinator Phone   (813) 745-6704 Study Coordinator Email   Marjorie.Brelsford@moffitt.org OVERVIEW – in layman’s terms (150 words max)   The purpose of this study is to test the efficacy of the immunotherapy agent nivolumab in patients with advanced, refractory biliary cancers (intrahepatic and extrahepatic cholangiocarcinoma and gallbladder cancer). Patients will be evaluated for progression-free survival, overall survival and... read more

STARTRK-2: An Open-Label, Multicenter, Global Phase 2 Basket Study of Entrectinib for the Treatment of Patients with Locally Advanced or Metastatic Solid Tumors (including cholangiocarcinoma) that Harbor NTRK1/2/3, ROS1, or ALK Gene Rearrangements

Study Name STARTRK-2: An Open-Label, Multicenter, Global Phase 2 Basket Study of Entrectinib for the Treatment of Patients with Locally Advanced or Metastatic Solid Tumors(including cholangiocarcinoma) that Harbor NTRK1/2/3, ROS1, or ALK Gene Rearrangements ClinicalTrials.gov Identifier (if applicable) NCT02568267 Study Center Institution Name This is a multicenter, global trial enrolling patients with solid tumors (including cholangiocarcinoma). Please visit www.STARTRKtrials.com, or contact Ignyta at 1-844-STARTRK (782-7875) or via email at STARTRKtrials@ignyta.com to find a participating study center near you. Institution Address Ignyta Inc. City San Diego State California Zip Code 92121 Phone (844) 782-7875 Website https://www.STARTRKtrials.com/ List additional Institutions (include address, phone number, and website) This is a multicenter, global trial. Please visit www.STARTRKtrials.com, or contact Ignyta at 1-844-STARTRK (782-7875) or via email at STARTRKtrials@ignyta.com... read more

A Phase II Study of Gemcitabine, Cisplatin, and Abraxane in Advanced Biliary Cancers

Study Name   A Phase II Study of Gemcitabine, Cisplatin, and Abraxane in Advanced Biliary Cancers ClinicalTrials.gov Identifier (if applicable)   NCT02392637 Study Center Institution Name   MD Anderson Cancer Center Institution Address   1515 Holcombe Blvd, Unit 426 City   Houston State   Texas Zip Code   77030 Phone   (713) 792-2828 List additional Institutions (include address, phone number, and website)   Mayo Clinic Scottsdale Study Contacts Principal Investigator   Rachna Shroff, MD P.I. Phone   (713) 792-2828 P.I. Email   rshroff@mdanderson.org List additional Principal Investigators (include phone number and email)   Mitesh Borad, MD Study Coordinator   Michiko Iwasaki Study Coordinator Phone   (713) 792-2828 Study Coordinator Email   miwasaki@mdanderson.org OVERVIEW – in layman’s terms (150 words max)   The purpose of... read more

Study of LOXO-101 in Subjects With NTRK Fusion Positive Solid Tumors Phase II, multi-center, open-label study of patients with advanced solid tumors harboring a fusion of NTRK1, NTRK2 or NTRK3

Study Name Study of LOXO-101 in Subjects With NTRK Fusion Positive Solid Tumors Phase II, multi-center, open-label study of patients with advanced solid tumors harboring a fusion of NTRK1, NTRK2 or NTRK3 ClinicalTrials.gov Identifier (if applicable) NCT02576431 Study Center Institution Name This study is being conducted internationally. Contact the LOXO-101 team thru the Study Contact number to find the site nearest to you. Institution Address Loxo Oncology-400 Oyster Point Drive City South San Francisco State California Zip Code 94080 Website http://www.loxooncology.com List additional Institutions (include address, phone number, and website) This study is being conducted Internationally. Contact the LOXO-101 team thru the Study Contact number to find the site nearest you. Study Contacts Principal Investigator Loxo Oncology P.I. Phone (855) 687-5123 P.I. Email kherani@loxooncology.com... read more

Multicenter, Open-label, Randomized, Controlled Phase III Clinical Study of the Efficacy and Safety of Photodynamic Therapy Using Porfimer Sodium for Injection as Treatment for Unresectable Advanced Perihilar Cholangiocarcinoma

STUDY NAME: Multicenter, Open-label, Randomized, Controlled Phase III Clinical Study of the Efficacy and Safety of Photodynamic Therapy Using Porfimer Sodium for Injection as Treatment for Unresectable Advanced Perihilar Cholangiocarcinoma ClinicalTrials.gov Identifier: NCT02082522 View Our Recorded Webinar STUDY CENTER: A total of 40 centers in North America, Europe and Asia will participate. Please see ClinicalTrials.gov as sites are added. United States Arizona, Florida, Minnesota Mayo Clinic Cancer Center Contact: Clinical Trials Office All Mayo Clinic Locations 855-776-0015 (toll-free) Arizona Western Regional Medical Center, Inc. Goodyear, Arizona, USA Principal Investigator: Dr. Toufic Kachaamy Contact: Pamela Haire Phone: 623-207-3955 Email: pamela.haire@ctca-hope.com California UC Davis Medical Center Sacramento, California 95817 Principal Investigator: Shiro Urayama, MD Contact: Lisa A Wilson Phone: 916-903-9198 Email: lawilson@ucdavis.edu University of Southern California Keck... read more

Study of DKN-01 and Gemcitabine/Cisplatin in Patients With Cholangiocarcinoma (Bile Duct Cancer)

Study Name: Study of DKN-01 and Gemcitabine/Cisplatin in Patients With Cholangiocarcinoma (Bile Duct Cancer) ClinicalTrials.gov Identifier: NCT02375880 Institution Name: Columbia University Medical Center Herbert Irving Comprehensive Cancer Center Institution Address: 161 Fort Washington Ave, New York, NY 10032 Additional Institutions: Yale University: New Haven, Connecticut, United States, 06520 Contact: Kirsten Dooley, 203-785-2836 Dana Farber Cancer Institute: Boston, Massachusetts, United States, 02215 Contact: Margaret Carey, 617-632-5575 Massachusetts General Hospital: Boston, Massachusetts, United States, 02214 Contact: Carolyn Finocchiaro, 617-724-4000 Principal Investigator: Abby Siegel, MD, (212) 304-5570, aas54@cumc.columbia.edu Additional Principal Investigators: Yale University, New Haven, Connecticut, United States, 06520, Principal Investigator: Stacey Stein, MD, 203-737-1600, stacey.stein@yale.edu Dana Farber Cancer Institute, Boston, Massachusetts United States, 02215, Principal Investigator: Thomas Abrams, MD, 617-632-6932, thomas_abrams@dfci.harvard.edu Massachusetts General Hospital, Boston, Massachusetts,... read more

A Phase I Study of IDH305 in Patients with Advanced Malignancies that Harbor IDH1R132 Mutations

Study Name: A Phase I Study of IDH305 in Patients with Advanced Malignancies that Harbor IDH1R132 Mutations ClinicalTrials.gov Identifier (if applicable): NCT02381886 Institution Name: MD Anderson Cancer Center Institution Address: 1515 Holcombe Blvd, Unit 426, Houston, TX 77030 Phone: (713)563-1193 Principal Investigator: FILIP JANKU, MD, (713)563-1193, vstepane@mdanderson.org Milind Javle, MD. Email: mjavle@mdanderson.org; 713-792-2828 Study Coordinator: Vanda Stepanek, (713)563-1193, vstepane@mdanderson.org Overview: This study will enroll patients with cholangiocarcinoma, acute myeloid leukemia and glioma having IDH1R132 mutation in a clinical trial with the IDH1 inhibitor IDH305. Patients must have received one prior chemotherapy and demonstrated progression after the same. The phase I study will be followed by study expansions in cholangiocarcinoma. Enrollment: 140 Study Start Date: 3/2/15 Estimated Completion Date: 11/1/17 Purpose of the Study –... read more

Phase I/IIA Study MK-3475 With Chemotherapy in Patients With Advanced GI Cancers (MK-3475 GI)

Study Name: Phase I/IIA Study MK-3475 With Chemotherapy in Patients With Advanced GI Cancers (MK-3475 GI) ClinicalTrials.gov Identifier (if applicable): NCT02268825 Institution Name: Huntsman Cancer Institute Institution Address: 2000 Circle of Hope, Salt Lake City, UT, 84112 Website: http://healthcare.utah.edu/huntsmancancerinstitute/clinical-trials/ Principal Investigator: Sunil Sharma, MD, (801)581-4477, sunil.sharma@hci.utah.edu Study Coordinator: Rachel Kingsford, (801)585-0115, rachel.kingsford@hci.utah.edu Overview: This is a trial to assess MK-3475 in combination with mFOLFOX6 followed by a Phase II open label, nonrandomized trial with MK-3475 at MTD in combination with mFOLFOX6 in 4 cohorts of advanced/metastatic GI malignancies (pancreatic, gastro esophageal, colorectal and biliary carcinoma) to assess response rate, clinical benefit rate and survival Enrollment: 128 Study Start Date: 1/23/15 Estimated Completion Date: 1/23/17 Purpose of the Study – in Layman’s Terms: Response Rate|Clinical... read more

Randomized Phase III Study of Focal Radiation Therapy for Unresectable, Localized Intrahepatic Cholangiocarcinoma

Study Name: NRG-GI001: Randomized Phase III Study of Focal Radiation Therapy for Unresectable, Localized Intrahepatic Cholangiocarcinoma Institution Name: NRG Oncology, Massachusetts Principal Investigator: Ted Hong, (617) 724-1159, TSHONG1@mgh.harvard.edu Additional Principal Investigators: Theodore Hong, MD Massachusetts General Hospital 100 Blossom Street, Boston, MA 00214, 617-724-1159/Fax: 617-726-3603 TSHONG1@mgh.harvard.edu Laura A. Dawson, MD, Princess Margaret Cancer Centre University of Toronto, 610 University Avenue, Toronto, ON, Canada MSG 2M9, 416-946-2125/Fax: 416-946-6566, Laura.dawson@rmp.uhn.on.ca Study Coordinator: Ted Hong Study Coordinator Phone: (617) 724-1159 Study Coordinator Email: TSHONG1@mgh.harvard.edu Overview: To evaluate the addition of liver-directed radiation therapy to chemotherapy with respect to overall survival (OS) for patients with unresectable, localized intrahepatic cholangiocarcinoma Enrollment: 182 Study Start Date: 11/25/14 Estimated Completion Date: 6/26/19 Purpose of the Study – in Layman’s Terms: To... read more

ClinicalTrials.gov

ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world.

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