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, United States, 02214, Principal Investigator: Lipika Goyal, MD, 617-724-4000, LGOYAL@PARTNERS.ORG

Study Coordinator: Rana Abdelhamid

Study Coordinator Phone: (212) 304-5570

Study Coordinator Email: ra2790@columbia.edu

Additional Study Coordinators:

  • Yale University Recruiting, New Haven, Connecticut, United States, 06520, Contact: Kirsten Dooley, 203-785-2836, kirsten.dooley@yale.edu
  • Principal Investigator: Stacey Stein, MD, United States, Massachusetts

Overview: This study is testing how an investigational drug (DKN-01) combined with gemcitabine and cisplatin works in people with biliary or gallbladder cancer. DKN-01 is an antibody that blocks the function of a protein called dickkopf-1 (Dkk-1). Too much Dkk-1 in tumor tissue may contribute to tumor growth and spread of biliary and gallbladder cancer.

Enrollment: up to 32 patients

Study Start Date: 6/1/15

Estimated Completion Date: 7/31/17

Purpose of the Study – in Layman’s Terms: To evaluate the safety and tolerability of DKN-01 in combination with gemcitabine and cisplatin in patients with cholangiocarcinoma|To estimate the response rate and survival of patients with cholangiocarcinoma treated with DKN-01 in combination with gemcitabine and cisplatin

Inclusion Criteria – Patients Must: Have cholangiocarcinoma (bile duct) or gallbladder cancer.|Have 28 days pass since prior local therapy for his/her cancer.|Have measurable disease on radiographic imaging.|Have a 6 month window since prior adjuvant chemotherapy with gemcitabine with or without cisplatin|Be greater than 30 years of age|Have adequate blood test results|Be disease-free of other cancers for ≥ 2 years with the exception of currently treated basal cell or squamous cell carcinoma of the skin, or carcinoma in-situ of the cervix or breast|Agree to use adequate contraception during the study and for 6 months after their last dose of study drug|Be available for the duration of the study and are willing to follow study-specific procedures|Sign Informed Consent

Exclusion Criteria – Patients Must NOT: Have serious medical conditions which could limit study participation|Have had treatment with surgery or chemotherapy within 21 days prior to study entry or radiation within 14 days of study entry|Have an active infection|Have had a prior organ transplant|Be pregnant or breast-feeding|Have a history of osteonecrosis of the hip or have evidence of structural bone abnormalities in the hip that are symptomatic and clinically significant|Have significant peripheral neuropathy (numbness in fingers or toes)

Required Tests Prior to Beginning Study Treatment: Screening assessments include a medical history, vital signs, physical exam, an assessment of how the cancer affects daily living activities, current medications, blood and urine tests, electrical tracing of heart activity (electrocardiogram-ECG), solid tumor measurement, radiologic assessment, and submission of a tumor biopsy sample (obtained less than 24 months prior to study entry).

Potential Side-Effects: DKN-01 is an experimental drug that has been given to 62 people in two completed studies and additional patients in two other studies that are ongoing. This is the first study in which DKN-01 is being tested as a treatment for your type of cancer. In one of the completed studies, the most commonly reported side effects were headache, bruising at the injection site, and viral infection. In the other completed study, the most commonly reported side effects were nausea, fatigue, decreased appetite, shortness of breath, vomiting, and constipation. Side effects that the treating doctors considered to be related to treatment with DKN-01 were fatigue, nausea, weakness, and changes in the sense of taste. Administration of gemcitabine and cisplatin is used to treat several different types of cancer and additional side effects may be experienced with these standard of care medications. While there is always the risk of a very rare or previously unknown side effect occurring, safety is being closely followed in the two ongoing studies and will carefully monitored in this study.

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