A Study of Ramucirumab (LY3009806) or Merestinib (LY2801653) in Advanced or Metastatic Biliary Tract Cancer

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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