A Study of Ramucirumab (LY3009806) or Merestinib (LY2801653) in Advanced or Metastatic Biliary Tract Cancer
Status: | Active, not recruiting |
---|---|
Conditions: | Cancer, Cancer, Cancer, Cancer, Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/7/2019 |
Start Date: | May 19, 2016 |
End Date: | December 15, 2019 |
Randomized, Double-Blind, Phase 2 Study of Ramucirumab or Merestinib or Placebo Plus Cisplatin and Gemcitabine as First-Line Treatment in Patients With Advanced or Metastatic Biliary Tract Cancer
The main purpose of this study is to evaluate the efficacy and safety of ramucirumab or
merestinib or placebo plus cisplatin and gemcitabine in participants with advanced or
metastatic biliary tract cancer.
merestinib or placebo plus cisplatin and gemcitabine in participants with advanced or
metastatic biliary tract cancer.
Inclusion Criteria:
- Have an Eastern Cooperative Oncology Group performance status of 0 or 1.
- Have a histologically or cytologically confirmed diagnosis of non-resectable,
recurrent, or metastatic biliary tract adenocarcinoma (intrahepatic or extrahepatic
cholangiocarcinoma, gallbladder cancer, or Ampulla of Vater) .
- Have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST).
- Have adequate biliary drainage.
- Have adequate organ function.
- Males and females are sterile, postmenopausal, or compliant with a highly effective
contraceptive method.
- Female participants of childbearing potential must have a negative serum pregnancy
test within 7 days prior to first dose.
- Are willing to provide blood/serum/plasma and tumor tissue samples for research
purposes. Submission of blood/serum/plasma and tumor tissue samples is mandatory for
participation in this study, unless restricted per local regulations.
Exclusion Criteria:
- Previous systemic therapy for locally advanced or metastatic disease is not allowed.
- Have a history of or have current hepatic encephalopathy of any grade, or ascites of
Grade >1, or cirrhosis with Child-Pugh Stage B or higher.
- Have ongoing or recent (≤6 months) hepatorenal syndrome.
- Have had a major surgical procedure or significant traumatic injury including
nonhealing wound, peptic ulcer, or bone fracture ≤28 days prior to randomization.
- Anticipate having a major surgical procedure during the course of the study.
- Has documented brain metastases, leptomeningeal disease, or uncontrolled spinal cord
compression.
- Within 6 months prior to randomization, have had any arterial thrombotic event,
including myocardial infarction, unstable angina, cerebrovascular accident, or
transient ischemic attack.
- Have an uncontrolled arterial hypertension with systolic blood pressure ≥150 or
diastolic blood pressure ≥90 millimeters of mercury (mm Hg) despite standard medical
management.
- Have a previous malignancy within 5 years of study entry or a concurrent malignancy.
- Have a history of gastrointestinal perforation and/or fistulae within 6 months prior
to randomization.
- Have a known allergy or hypersensitivity reaction to any of the treatment components.
- Have a history of uncontrolled hereditary or acquired thrombotic disorder.
- Have uncontrolled metabolic disorders or other nonmalignant organ or systemic diseases
or secondary effects of cancer that induce a high medical risk and/or make assessment
of survival uncertain.
- Have mixed hepatocellular biliary tract cancer histology.
- Have a corrected QT interval >470 milliseconds as calculated be the Fredericia
equation.
We found this trial at
18
sites
Saint Petersburg, Florida 33705
Principal Investigator: Jennifer Cultrera
Phone: 352-753-9777
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3840 Broadway
Fort Myers, Florida 33901
Fort Myers, Florida 33901
(239) 275-6400
Principal Investigator: Syed Zafar
Phone: 239-274-9930
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1211 Medical Center Dr
Nashville, Tennessee 37232
Nashville, Tennessee 37232
(615) 322-5000
Principal Investigator: Laura Goff
Phone: 615-936-5184
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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Detroit, Michigan 48201
Principal Investigator: Philip Philip
Phone: 313-576-8728
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12901 Bruce B Downs Boulevard
Gainesville, Florida 33612
Gainesville, Florida 33612
Principal Investigator: Thomas George
Phone: 352-273-8008
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1441 Eastlake Avenue
Los Angeles, California 90033
Los Angeles, California 90033
Principal Investigator: Anthony El-Khoueiry
Phone: 323-865-3967
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2160 South 1st Avenue
Maywood, Illinois 60153
Maywood, Illinois 60153
(888) 584-7888
Principal Investigator: Asha Dhanarajan
Phone: 708-216-9000
Loyola University Medical Center Loyola University Health System is committed to excellence in patient care...
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230 25th Ave N
Nashville, Tennessee 37203
Nashville, Tennessee 37203
(615) 329-7274
Principal Investigator: SMO Sarah Cannon Research Inst.
Phone: 615-239-7615
Sarah Cannon Cancer Center People who live with cancer
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250 25th Ave N, Ste 100
Nashville, Tennessee 37023
Nashville, Tennessee 37023
615-320-5090
Principal Investigator: Johanna Bendell
Phone: 615-329-7274
Tennessee Oncology, PLLC Since 1976 Tennessee Oncology has been providing quality cancer care. In 2013,...
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1020 Walnut St
Philadelphia, Pennsylvania 19107
Philadelphia, Pennsylvania 19107
(215) 955-6000
Principal Investigator: Ashwin Sama
Phone: 215-955-0687
Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
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Philadelphia, Pennsylvania 19111
Principal Investigator: Crystal Denlinger
Phone: 215-214-1676
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Providence, Rhode Island 02903
Principal Investigator: Rimini Breakstone
Phone: 401-444-4000
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Saint Louis, Missouri 63110
Principal Investigator: Kian Lim
Phone: 314-362-9115
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San Francisco, California 94143
Principal Investigator: Robin Kelley
Phone: 415-353-9888
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Stony Brook, New York 11794
Principal Investigator: Minsig Choi
Phone: 631-444-3578
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3800 Reservoir Rd NW
Washington, District of Columbia 20007
Washington, District of Columbia 20007
(202) 687-7695
Georgetown University Medical Center Georgetown University Medical Center is committed to excellence in research, education...
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