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

Primary Purpose

Biliary Tract Cancer, Metastatic Cancer, Advanced Cancer

Status

Active

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Ramucirumab

Merestinib

Cisplatin

Gemcitabine

Placebo Oral

Placebo IV

About this trial

This is an interventional treatment trial for Biliary Tract Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arizona Cancer Center
USC Norris Cancer Hospital
USC Norris Cancer Hospital
University of California, San Francisco
Georgetown University Medical Center
Florida Cancer Specialists
University of Southern Florida School of Medicine
Florida Cancer Specialists
Loyola University Medical Center
Karmanos Cancer Institute
Washington University Medical Center
SUNY At Stony Brook
Thomas Jefferson University
Fox Chase Cancer Center
Hasbro Children's Hospital
Sarah Cannon Cancer Center
Tennessee Oncology PLLC
Vanderbilt University Medical Center
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Arkhangelsk Regional Clinical Oncology Dispensary
Blokhin Cancer Research Center
Central Roentgenoradiological Research Institute MZ RF
Hospital Clínico Universitario de Valencia
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Hospital 12 De Octubre
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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

8 mg/kg Ramucirumab + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine

Placebo IV + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine

80 mg Merestinib + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine

Placebo Oral + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine

Arm 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).

Participants received placebo (indistinguishable and equivalent volume to ramucirumab) plus 25 mg/m² cisplatin and 1000 mg/m² gemcitabine 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 placebo therapy).

Participants received 80 mg merestinib orally each day, plus 25 mg/m² cisplatin and 1000 mg/m² gemcitabine 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 merestinib therapy).

Participants received placebo (indistinguishable to merestinib) orally each day, plus 25 mg/m² cisplatin and 1000 mg/m² gemcitabine IV on Days 1 and 8, every 21 days. 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 placebo therapy).

Outcomes

Primary Outcome Measures

Progression Free Survival (PFS)

PFS time was measured from the date of randomization until the first radiographic documentation of progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, or death from any cause. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If a participant does not have a complete baseline disease assessment, then the PFS time was censored at the date of first dose, regardless of whether or not objectively determined disease progression or death has been observed for the participant. If a participant was not known to have died or have objective progression as of the data inclusion cutoff date for the analysis, the PFS time was censored at the last adequate tumor assessment date.

Secondary Outcome Measures

Overall Survival (OS)

OS defined as the time from from randomization to the date of death due to any cause. For each participant who is not known to have died as of the data-inclusion cutoff date for overall survival analysis, OS time was censored on the last date the participant is known to be alive.

Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR): Objective Response Rate (ORR)

ORR was the number of participants who achieve a best overall response of CR or PR divided by the total number of participants randomized to the corresponding treatment arm as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.

Percentage of Participants With a Best Overall Response of CR, PR, or Stable Disease (SD): Disease Control Rate (DCR)

Disease Control Rate (DCR) was the number of participants who achieve a best overall response of CR, PR, or SD divided by the total number of participants randomized to the corresponding treatment arm as per RECIST v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD for target lesions, no progression of non-target lesions, and no appearance of new lesions. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.

Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab

PK was determined by the minimum observed plasma concentration (Cmin). 1 Cycle (C) = 21 days (D).

PK: Plasma Concentration of Merestinib

PK was presented through graphical overlay comparison versus historic data. No numerical summary of data was intended or produced.

Number of Participants With Treatment-Emergent Anti-Ramucirumab Antibodies

Number of participants with positive treatment emergent anti-ramucirumab antibodies (ADA) was summarized by treatment group.

Change From Baseline in Functional Assessment of Cancer Therapy Hepatobiliary Questionnaire (FACT-Hep)

FACT-Hep consists of 45 items in five subscales (1) physical well-being (PWB) score rage 0 -28; (2) social well-being (SWB) score range 0-28; (3) emotional well-being (EWB) score range 0-24; (4) functional well-being (FWB) score range 0-28; and (5) the hepatobiliary cancer subscale (HCS) Score range 0-72. The Trial Outcomes Index (TOI) is the sum of the PWB, FWB and Hep subscales with a scores range of 0 to 128. The Total FACT-Hep score was the sum of all questions with a scores range of 0 to 180.Total FACT-G score was the sum of the 27 questions in the PWB, SFWB, EWB and FWB with a scores range of 0 to 108. The FACT-Hep Symptoms Index with 8 key questions and scores range of 0 to 32 from the Hep Subscale. Higher score in sub-score or total score indicates better QOL and better health state. Participants were classified as "Improved" if they had positive change from baseline, "Worsened" if they had negative change from baseline, and "Stable" otherwise.

Change From Baseline on the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Index Score

EQ-5D-5L is a 2-part questionnaire that assesses general health status for 'today'. The first part is comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using country-specific algorithms, with scores ranging from less than 0 (where zero is a health state equivalent to death; negative values are valued as worse than dead) to 1 (perfect health). Index values were calculated using the US algorithm (-0.109 to 1). A higher score indicates better health state.

Change From Baseline in Participant-Reported EQ-5D-5L Visual Analog Scale (VAS) Score

EQ-5D-5L is a 2-part questionnaire that assesses general health status 'today'. The second part is assessed using a VAS on which the patient rates their perceived health state, ranging from 0 millimeter (the worst health you can imagine) to 100 millimeter (the best health you can imagine).

Full Information

NCT ID

NCT02711553

First Posted

March 14, 2016

Last Updated

April 12, 2023

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT02711553

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 1, 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

May 19, 2016 (Actual)

Primary Completion Date

February 16, 2018 (Actual)

Study Completion Date

December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Biliary Tract Cancer, Metastatic Cancer, Advanced Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

309 (Actual)

8. Arms, Groups, and Interventions

Arm Title

8 mg/kg Ramucirumab + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine

Arm Type

Experimental

Arm Description

Arm Title

Placebo IV + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine

Arm Type

Placebo Comparator

Arm Description

Arm Title

80 mg Merestinib + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine

Arm Type

Experimental

Arm Description

Arm Title

Placebo Oral + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Ramucirumab

Other Intervention Name(s)

LY3009806

Intervention Description

Administered IV

Intervention Type

Drug

Intervention Name(s)

Merestinib

Other Intervention Name(s)

LY2801653

Intervention Description

Administered orally

Intervention Type

Drug

Intervention Name(s)

Cisplatin

Intervention Description

Administered IV

Intervention Type

Drug

Intervention Name(s)

Gemcitabine

Other Intervention Name(s)

LY188011

Intervention Description

Administered IV

Intervention Type

Drug

Intervention Name(s)

Placebo Oral

Intervention Description

Administered orally

Intervention Type

Drug

Intervention Name(s)

Placebo IV

Intervention Description

Administered IV

Primary Outcome Measure Information:

Title

Progression Free Survival (PFS)

Description

Time Frame

Randomization to Progressive Disease or Death from Any Cause (Up To 20 Months)

Secondary Outcome Measure Information:

Title

Overall Survival (OS)

Description

Time Frame

Randomization to Date of Death from Any Cause (Up To 48 Months)

Title

Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR): Objective Response Rate (ORR)

Description

Time Frame

Randomization to Disease Progression (Up To 30 Months)

Title

Percentage of Participants With a Best Overall Response of CR, PR, or Stable Disease (SD): Disease Control Rate (DCR)

Description

Time Frame

Randomization to Disease Progression (Up To 30 Months)

Title

Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab

Description

PK was determined by the minimum observed plasma concentration (Cmin). 1 Cycle (C) = 21 days (D).

Time Frame

C1 D8, C2 D1, C3 D1, C4 D1,C5 D1,C7 D1, C9 D1 and C13 D1: Within 3 days Prior to Infusion(PTI)

Title

PK: Plasma Concentration of Merestinib

Description

PK was presented through graphical overlay comparison versus historic data. No numerical summary of data was intended or produced.

Time Frame

C1 D8; C2 D1; C4 D1; C6 D1; C8 D1; C2 D8; C4 D8; C6 D8; C8 D8: Morning

Title

Number of Participants With Treatment-Emergent Anti-Ramucirumab Antibodies

Description

Number of participants with positive treatment emergent anti-ramucirumab antibodies (ADA) was summarized by treatment group.

Time Frame

Predose Cycle 1 Day 1 through Follow Up (Up To 48 Months)

Title

Change From Baseline in Functional Assessment of Cancer Therapy Hepatobiliary Questionnaire (FACT-Hep)

Description

Time Frame

Baseline, Follow Up (Up To 48 Months)

Title

Change From Baseline on the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Index Score

Description

Time Frame

Baseline, Follow Up (Up To 48 Months)

Title

Change From Baseline in Participant-Reported EQ-5D-5L Visual Analog Scale (VAS) Score

Description

Time Frame

Baseline, Follow Up (Up To 48 Months)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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)

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name

Arizona Cancer Center

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85724

Country

United States

Facility Name

USC Norris Cancer Hospital

City

Los Angeles

State/Province

California

ZIP/Postal Code

90003

Country

United States

Facility Name

USC Norris Cancer Hospital

City

Los Angeles

State/Province

California

ZIP/Postal Code

90033

Country

United States

Facility Name

University of California, San Francisco

City

San Francisco

State/Province

California

ZIP/Postal Code

94143

Country

United States

Facility Name

Georgetown University Medical Center

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20007

Country

United States

Facility Name

Florida Cancer Specialists

City

Fort Myers

State/Province

Florida

ZIP/Postal Code

33916

Country

United States

Facility Name

University of Southern Florida School of Medicine

City

Gainesville

State/Province

Florida

ZIP/Postal Code

33612

Country

United States

Facility Name

Florida Cancer Specialists

City

Saint Petersburg

State/Province

Florida

ZIP/Postal Code

33705

Country

United States

Facility Name

Loyola University Medical Center

City

Maywood

State/Province

Illinois

ZIP/Postal Code

60153

Country

United States

Facility Name

Karmanos Cancer Institute

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48201

Country

United States

Facility Name

Washington University Medical Center

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Facility Name

SUNY At Stony Brook

City

Stony Brook

State/Province

New York

ZIP/Postal Code

11794

Country

United States

Facility Name

Thomas Jefferson University

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19107

Country

United States

Facility Name

Fox Chase Cancer Center

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19111-2497

Country

United States

Facility Name

Hasbro Children's Hospital

City

Providence

State/Province

Rhode Island

ZIP/Postal Code

02903

Country

United States

Facility Name

Sarah Cannon Cancer Center

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37203

Country

United States

Facility Name

Tennessee Oncology PLLC

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37203

Country

United States

Facility Name

Vanderbilt University Medical Center

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37232

Country

United States

Facility Name

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

City

Buenos Aires

ZIP/Postal Code

1426

Country

Argentina

Facility Name

City

Capital Federal

ZIP/Postal Code

C1264AAA

Country

Argentina

Facility Name

City

Ciudad de Buenos Aires

ZIP/Postal Code

1093

Country

Argentina

Facility Name

City

La Rioja

ZIP/Postal Code

5300

Country

Argentina

Facility Name

City

San Juan

ZIP/Postal Code

J5402DIL

Country

Argentina

Facility Name

City

San Miguel de Tucumán

ZIP/Postal Code

T4000IAK

Country

Argentina

Facility Name

City

San Salvador de Jujuy

ZIP/Postal Code

Y4600APW

Country

Argentina

Facility Name

City

Viedma

ZIP/Postal Code

8500

Country

Argentina

Facility Name

City

Adelaide

ZIP/Postal Code

5000

Country

Australia

Facility Name

City

Douglas

ZIP/Postal Code

4814

Country

Australia

Facility Name

City

Heidelberg

ZIP/Postal Code

3084

Country

Australia

Facility Name

City

Newcastle

ZIP/Postal Code

Newcastle

Country

Australia

Facility Name

City

Salzburg

ZIP/Postal Code

5020

Country

Austria

Facility Name

City

Wiener Neustadt

ZIP/Postal Code

2700

Country

Austria

Facility Name

City

Wien

ZIP/Postal Code

1020

Country

Austria

Facility Name

City

Brussels

ZIP/Postal Code

1200

Country

Belgium

Facility Name

City

Gent

ZIP/Postal Code

9000

Country

Belgium

Facility Name

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

City

Liege

ZIP/Postal Code

4000

Country

Belgium

Facility Name

City

Brno

ZIP/Postal Code

656 53

Country

Czechia

Facility Name

City

Hradec Kralove

ZIP/Postal Code

500 05

Country

Czechia

Facility Name

City

Praha 5

ZIP/Postal Code

150 06

Country

Czechia

Facility Name

City

Aarhus C

ZIP/Postal Code

8000

Country

Denmark

Facility Name

City

Odense C

ZIP/Postal Code

5000

Country

Denmark

Facility Name

City

Besancon Cedex

ZIP/Postal Code

25030

Country

France

Facility Name

City

Bordeaux Cedex

ZIP/Postal Code

33000

Country

France

Facility Name

City

Lille

ZIP/Postal Code

59037

Country

France

Facility Name

City

Lyon Cedex 08

ZIP/Postal Code

69373

Country

France

Facility Name

City

Montpellier Cedex 5

ZIP/Postal Code

34295

Country

France

Facility Name

City

Nice Cedex 2

ZIP/Postal Code

06189

Country

France

Facility Name

City

Paris

ZIP/Postal Code

75010

Country

France

Facility Name

City

Strasbourg

ZIP/Postal Code

67000

Country

France

Facility Name

City

Villejuif Cedex

ZIP/Postal Code

94805

Country

France

Facility Name

City

Berlin

ZIP/Postal Code

13125

Country

Germany

Facility Name

City

Erlangen

ZIP/Postal Code

91054

Country

Germany

Facility Name

City

Hamburg

ZIP/Postal Code

20246

Country

Germany

Facility Name

City

Hannover

ZIP/Postal Code

30625

Country

Germany

Facility Name

City

Tübingen

ZIP/Postal Code

72076

Country

Germany

Facility Name

City

Ulm

ZIP/Postal Code

89081

Country

Germany

Facility Name

City

Budapest

ZIP/Postal Code

1097

Country

Hungary

Facility Name

City

Debrecen

ZIP/Postal Code

4032

Country

Hungary

Facility Name

City

Chiba

ZIP/Postal Code

277 8577

Country

Japan

Facility Name

City

Tokyo

ZIP/Postal Code

104-0045

Country

Japan

Facility Name

City

Seoul

ZIP/Postal Code

03080

Country

Korea, Republic of

Facility Name

City

Seoul

ZIP/Postal Code

03722

Country

Korea, Republic of

Facility Name

City

Seoul

ZIP/Postal Code

05505

Country

Korea, Republic of

Facility Name

City

Seoul

ZIP/Postal Code

06351

Country

Korea, Republic of

Facility Name

City

Mexico City

ZIP/Postal Code

14080

Country

Mexico

Facility Name

City

Mexico

ZIP/Postal Code

06700

Country

Mexico

Facility Name

City

San Luis Potosi

ZIP/Postal Code

78213

Country

Mexico

Facility Name

Arkhangelsk Regional Clinical Oncology Dispensary

City

Arkhangelsk

ZIP/Postal Code

163045

Country

Russian Federation

Facility Name

Blokhin Cancer Research Center

City

Moscow

ZIP/Postal Code

115478

Country

Russian Federation

Facility Name

Central Roentgenoradiological Research Institute MZ RF

City

St. Petersburg

ZIP/Postal Code

197758

Country

Russian Federation

Facility Name

Hospital Clínico Universitario de Valencia

City

Barcelona

ZIP/Postal Code

46010

Country

Spain

Facility Name

City

Hospitalet De Llobregat

ZIP/Postal Code

08908

Country

Spain

Facility Name

Hospital 12 De Octubre

City

Madrid

ZIP/Postal Code

28041

Country

Spain

Facility Name

City

Danderyd

ZIP/Postal Code

182 88

Country

Sweden

Facility Name

City

Lund

ZIP/Postal Code

22185

Country

Sweden

Facility Name

City

Kaohsiung

ZIP/Postal Code

83301

Country

Taiwan

Facility Name

City

Taichung

ZIP/Postal Code

40447

Country

Taiwan

Facility Name

City

Tainan

ZIP/Postal Code

70403

Country

Taiwan

Facility Name

City

Taipei

ZIP/Postal Code

11217

Country

Taiwan

Facility Name

City

Taoyuan City

ZIP/Postal Code

33305

Country

Taiwan

Facility Name

City

Adana

ZIP/Postal Code

1250

Country

Turkey

Facility Name

City

Ankara

ZIP/Postal Code

06100

Country

Turkey

Facility Name

City

Antalya

ZIP/Postal Code

07059

Country

Turkey

Facility Name

City

Edirne

ZIP/Postal Code

22030

Country

Turkey

Facility Name

City

Istanbul

ZIP/Postal Code

34098

Country

Turkey

Facility Name

City

Acton

ZIP/Postal Code

W12 0HS

Country

United Kingdom

Facility Name

City

London

ZIP/Postal Code

NW1 2BU

Country

United Kingdom

Facility Name

City

London

ZIP/Postal Code

SE1 9RT

Country

United Kingdom

Facility Name

City

Manchester

ZIP/Postal Code

M20 4BX

Country

United Kingdom

Facility Name

City

Merseyside

ZIP/Postal Code

CH63 4JY

Country

United Kingdom

Facility Name

City

Sutton

ZIP/Postal Code

SM2 5PT

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

IPD Sharing Time Frame

Data are available 6 months after the primary publication and approval of the indication studied in the US and european union (EU), whichever is later. Data will be indefinitely available for requesting.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing URL

https://vivli.org/

Citations:

PubMed Identifier

34592180

Citation

Valle JW, Vogel A, Denlinger CS, He AR, Bai LY, Orlova R, Van Cutsem E, Adeva J, Chen LT, Obermannova R, Ettrich TJ, Chen JS, Wasan H, Girvan AC, Zhang W, Liu J, Tang C, Ebert PJ, Aggarwal A, McNeely SC, Moser BA, Oliveira JM, Carlesi R, Walgren RA, Oh DY. Addition of ramucirumab or merestinib to standard first-line chemotherapy for locally advanced or metastatic biliary tract cancer: a randomised, double-blind, multicentre, phase 2 study. Lancet Oncol. 2021 Oct;22(10):1468-1482. doi: 10.1016/S1470-2045(21)00409-5. Erratum In: Lancet Oncol. 2021 Nov;22(11):e472.

Results Reference

derived

Links:

URL

https://trials.lillytrialguide.com/en-US/trial/3MKeCKU0hiwqg4gsAMgAEs

Description

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

Learn more about this trial

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

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