Brief Title
A Study of Ramucirumab (LY3009806) or Merestinib (LY2801653) in Advanced or Metastatic Biliary Tract Cancer
Official Title
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
Brief Summary
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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Progression Free Survival (PFS)
Secondary Outcome
Overall Survival (OS)
Condition
Biliary Tract Cancer
Intervention
Ramucirumab
Study Arms / Comparison Groups
8 mg/kg Ramucirumab + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine
Description: Participants received 8 mg/kg ramucirumab plus 25 mg/square meter (mg/m²) cisplatin and 1000 mg/m² gemcitabine intravenously (IV) on days 1 and 8, every 21 days (1 cycle). Participants may continue on study drug for up to 8 cycles (for cisplatin and gemcitabine therapy) or until disease progression, unacceptable toxicity, or other withdrawal criterion is met (for ramucirumab therapy).
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
309
Start Date
May 19, 2016
Completion Date
December 31, 2022
Primary Completion Date
February 16, 2018
Eligibility Criteria
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 by the Fridericia
equation.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), ,
Location Countries
Argentina
Location Countries
Argentina
Administrative Informations
NCT ID
NCT02711553
Organization ID
16329
Secondary IDs
I3O-MC-JSBF
Responsible Party
Sponsor
Study Sponsor
Eli Lilly and Company
Study Sponsor
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study Director, Eli Lilly and Company
Verification Date
September 1, 2021