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

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ClinicalTrials.gov Identifier: NCT02711553
Recruitment Status : Active, not recruiting
First Posted : March 17, 2016
Last Update Posted : March 27, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

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.

Condition or disease Intervention/treatment Phase
Biliary Tract Cancer Metastatic Cancer Advanced Cancer Drug: Ramucirumab Drug: Merestinib Drug: Cisplatin Drug: Gemcitabine Drug: Placebo Oral Drug: Placebo IV Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : January 1, 2016
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : May 2020


Arm Intervention/treatment
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.

Drug: Ramucirumab
Administered IV
Other Name: LY3009806
Drug: Cisplatin
Administered IV
Drug: Gemcitabine
Administered IV
Other Name: LY188011
Drug: Placebo IV
Administered 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.

Drug: Merestinib
Administered orally
Other Name: LY2801653
Drug: Cisplatin
Administered IV
Drug: Gemcitabine
Administered IV
Other Name: LY188011
Drug: Placebo Oral
Administered orally



Primary Outcome Measures :
  1. Progression Free Survival (PFS) [ Time Frame: Baseline to Progressive Disease or Death from Any Cause (Approximately 30 Months) ]

Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: Baseline to Date of Death from Any Cause (Approximately 48 Months) ]
  2. 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) ]
  3. 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) ]
  4. Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab [ Time Frame: Predose Cycle 1 Day 8 through Cycle 8 Day 8 (21 Day Cycles) ]
  5. PK: Plasma Concentration of Merestinib [ Time Frame: Cycle 1 through Cycle 8 (21 Day Cycles) ]
  6. Number of Participants with Treatment-Emergent Anti-Ramucirumab Antibodies [ Time Frame: Predose Cycle 1 Day 1 through Follow Up (Approximately 48 Months) ]
  7. Change from Baseline in Functional Assessment of Cancer Therapy Hepatobiliary Questionnaire (FACT-Hep) [ Time Frame: Baseline, Follow Up (Approximately 48 Months) ]
  8. Change from Baseline on the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) [ Time Frame: Baseline, Follow Up (Approximately 48 Months) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 be the Fredericia equation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02711553


  Show 92 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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

Additional Information:
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02711553     History of Changes
Other Study ID Numbers: 16329
I3O-MC-JSBF ( Other Identifier: Eli Lilly and Company )
2015-004699-31 ( EudraCT Number )
First Posted: March 17, 2016    Key Record Dates
Last Update Posted: March 27, 2018
Last Verified: March 2018

Additional relevant MeSH terms:
Neoplasm Metastasis
Biliary Tract Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
Digestive System Neoplasms
Neoplasms by Site
Biliary Tract Diseases
Digestive System Diseases
Gemcitabine
Ramucirumab
Cisplatin
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs