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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02711553
Recruitment Status : Active, not recruiting
First Posted : March 17, 2016
Last Update Posted : March 17, 2020
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE March 14, 2016
First Posted Date  ICMJE March 17, 2016
Last Update Posted Date March 17, 2020
Actual Study Start Date  ICMJE May 19, 2016
Actual Primary Completion Date February 16, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 14, 2016)
Progression Free Survival (PFS) [ Time Frame: Baseline to Progressive Disease or Death from Any Cause (Approximately 30 Months) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 14, 2016)
  • Overall Survival (OS) [ Time Frame: Baseline to Date of Death from Any Cause (Approximately 48 Months) ]
  • Proportion of Participants with a Best Overall Response of Complete Response (CR) or Partial Response (PR): Objective Response Rate (ORR) [ Time Frame: Baseline to Disease Progression (Approximately 30 Months) ]
  • Proportion of Participants with a Best Overall Response of CR, PR, or Stable Disease (SD): Disease Control Rate (DCR) [ Time Frame: Baseline to Disease Progression (Approximately 30 Months) ]
  • Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab [ Time Frame: Predose Cycle 1 Day 8 through Cycle 8 Day 8 (21 Day Cycles) ]
  • PK: Plasma Concentration of Merestinib [ Time Frame: Cycle 1 through Cycle 8 (21 Day Cycles) ]
  • Number of Participants with Treatment-Emergent Anti-Ramucirumab Antibodies [ Time Frame: Predose Cycle 1 Day 1 through Follow Up (Approximately 48 Months) ]
  • Change from Baseline in Functional Assessment of Cancer Therapy Hepatobiliary Questionnaire (FACT-Hep) [ Time Frame: Baseline, Follow Up (Approximately 48 Months) ]
  • Change from Baseline on the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) [ Time Frame: Baseline, Follow Up (Approximately 48 Months) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Ramucirumab (LY3009806) or Merestinib (LY2801653) in Advanced or Metastatic Biliary Tract Cancer
Official Title  ICMJE 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Biliary Tract Cancer
  • Metastatic Cancer
  • Advanced Cancer
Intervention  ICMJE
  • Drug: Ramucirumab
    Administered IV
    Other Name: LY3009806
  • Drug: Merestinib
    Administered orally
    Other Name: LY2801653
  • Drug: Cisplatin
    Administered IV
  • Drug: Gemcitabine
    Administered IV
    Other Name: LY188011
  • Drug: Placebo Oral
    Administered orally
  • Drug: Placebo IV
    Administered IV
Study Arms  ICMJE
  • Experimental: Ramucirumab

    A1: Ramucirumab plus cisplatin and gemcitabine intravenously (IV) on Days 1 and 8, every 21 days.

    A2: Placebo plus cisplatin and gemcitabine IV on Days 1 and 8, every 21 days.

    Interventions:
    • Drug: Ramucirumab
    • Drug: Cisplatin
    • Drug: Gemcitabine
    • Drug: Placebo IV
  • Experimental: Merestinib

    B1: Merestinib orally each day, plus cisplatin and gemcitabine IV on Days 1 and 8, every 21 days.

    B2: Placebo orally each day, plus cisplatin and gemcitabine IV on Days 1 and 8, every 21 days.

    Interventions:
    • Drug: Merestinib
    • Drug: Cisplatin
    • Drug: Gemcitabine
    • Drug: Placebo Oral
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: March 2, 2019)
306
Original Estimated Enrollment  ICMJE
 (submitted: March 14, 2016)
300
Estimated Study Completion Date  ICMJE February 1, 2021
Actual Primary Completion Date February 16, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Mexico,   Argentina,   Australia,   Austria,   Belgium,   Czechia,   Denmark,   France,   Germany,   Hungary,   Japan,   Korea, Republic of,   Russian Federation,   Spain,   Sweden,   Taiwan,   Turkey,   United Kingdom,   United States
Removed Location Countries Czech Republic,   Italy
 
Administrative Information
NCT Number  ICMJE NCT02711553
Other Study ID Numbers  ICMJE 16329
I3O-MC-JSBF ( Other Identifier: Eli Lilly and Company )
2015-004699-31 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eli Lilly and Company
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: 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) Eli Lilly and Company
PRS Account Eli Lilly and Company
Verification Date March 15, 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP