Trial · NCT02711553

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

NCT02711553, Phase 2, Active not recruiting, Eli Lilly and Company; results first posted 2021-02-26

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study of Ramucirumab (LY3009806) or Merestinib (LY2801653) in Advanced or Metastatic Biliary Tract Cancer. Trials, record NCT02711553. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02711553

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study of Ramucirumab (LY3009806) or Merestinib (LY2801653) in Advanced or Metastatic Biliary Tract Cancer
NCT number: NCT02711553
Status: Active not recruiting
Phases: Phase 2
Enrollment: 309 participants, actual
Lead sponsor: Eli Lilly and Company
Conditions: Biliary Tract Cancer, Metastatic Cancer, Advanced Cancer
Interventions: Ramucirumab, Merestinib, Cisplatin, Gemcitabine, Placebo Oral, Placebo IV
First posted: 2016-03-17
Last updated: 2026-07-22
Other registries' IDs: eudract:2015-004699-31
Results first posted: 2021-02-26

Source ClinicalTrials.gov

Registered outcomes10

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Progression Free Survival (PFS)	Randomization to Progressive Disease or Death from Any Cause (Up To 20 Months)	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	Overall Survival (OS)	Randomization to Date of Death from Any Cause (Up To 48 Months)	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.
Secondary	Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR): Objective Response Rate (ORR)	Randomization to Disease Progression (Up To 30 Months)	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.
Secondary	Percentage of Participants With a Best Overall Response of CR, PR, or Stable Disease (SD): Disease Control Rate (DCR)	Randomization to Disease Progression (Up To 30 Months)	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.
Secondary	Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab	C1 D8, C2 D1, C3 D1, C4 D1,C5 D1,C7 D1, C9 D1 and C13 D1: Within 3 days Prior to Infusion(PTI)	PK was determined by the minimum observed plasma concentration (Cmin). 1 Cycle (C) = 21 days (D).
Secondary	PK: Plasma Concentration of Merestinib	C1 D8; C2 D1; C4 D1; C6 D1; C8 D1; C2 D8; C4 D8; C6 D8; C8 D8: Morning	PK was presented through graphical overlay comparison versus historic data. No numerical summary of data was intended or produced.
Secondary	Number of Participants With Treatment-Emergent Anti-Ramucirumab Antibodies	Predose Cycle 1 Day 1 through Follow Up (Up To 48 Months)	Number of participants with positive treatment emergent anti-ramucirumab antibodies (ADA) was summarized by treatment group.
Secondary	Change From Baseline in Functional Assessment of Cancer Therapy Hepatobiliary Questionnaire (FACT-Hep)	Baseline, Follow Up (Up To 48 Months)	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.
Secondary	Change From Baseline on the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Index Score	Baseline, Follow Up (Up To 48 Months)	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.
Secondary	Change From Baseline in Participant-Reported EQ-5D-5L Visual Analog Scale (VAS) Score	Baseline, Follow Up (Up To 48 Months)	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).

Source ClinicalTrials.gov

Outcomes10

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Progression Free Survival (PFS)	Randomization to Progressive Disease or Death from Any Cause (Up To 20 Months)	All randomized participants. Censored participants: 8 mg/kg Ramucirumab + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine = 29; 80 mg Merestinib + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine = 34; Pooled Placebo = 25. Pooling is done in the placebo arm (Pooled Placebo) from both arms (Placebo IV + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine and Placebo Oral + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine) for analysis purpose and combined as pre-specified in protocol.	Months	MEDIAN
SECONDARY	Overall Survival (OS)	Randomization to Date of Death from Any Cause (Up To 48 Months)	All randomized participants. Censored participants: 8 mg/kg Ramucirumab + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine = 29; 80 mg Merestinib + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine = 34; Pooled Placebo = 25. Pooling is done in the placebo arm (Pooled Placebo) from both arms (Placebo IV + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine and Placebo Oral + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine) for analysis purpose and combined as pre-specified in protocol.	Months	MEDIAN
SECONDARY	Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR): Objective Response Rate (ORR)	Randomization to Disease Progression (Up To 30 Months)	All randomized participants. Pooling is done in the placebo arm (Pooled Placebo) from both arms (Placebo IV + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine and Placebo Oral + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine) for analysis purpose and combined as pre-specified in protocol.	Percentage of participants	NUMBER
SECONDARY	Percentage of Participants With a Best Overall Response of CR, PR, or Stable Disease (SD): Disease Control Rate (DCR)	Randomization to Disease Progression (Up To 30 Months)	All randomized participants. Pooling is done in the placebo arm (Pooled Placebo) from both arms (Placebo IV + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine and Placebo Oral + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine) for analysis purpose and combined as pre-specified in protocol.	Percentage of participants	NUMBER
SECONDARY	Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab	C1 D8, C2 D1, C3 D1, C4 D1,C5 D1,C7 D1, C9 D1 and C13 D1: Within 3 days Prior to Infusion(PTI)	All participants who received at least one dose of study drug and had evaluable PK data. As per protocol, Cmin of merestinib was not measured.	Microgram per milliliter (µg/mL)	GEOMETRIC_MEAN
SECONDARY	PK: Plasma Concentration of Merestinib	C1 D8; C2 D1; C4 D1; C6 D1; C8 D1; C2 D8; C4 D8; C6 D8; C8 D8: Morning	Zero participants were analyzed as no data collected for summary analysis.
SECONDARY	Number of Participants With Treatment-Emergent Anti-Ramucirumab Antibodies	Predose Cycle 1 Day 1 through Follow Up (Up To 48 Months)	All randomized participants who received at least 1 dose of study drug with both baseline and at least one post baseline ADA assessments.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Change From Baseline in Functional Assessment of Cancer Therapy Hepatobiliary Questionnaire (FACT-Hep)	Baseline, Follow Up (Up To 48 Months)	All randomized participants who received at least 1 dose of study drug with baseline and one post-baseline FACT-Hep Questionnaire.	Units on a Scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline on the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Index Score	Baseline, Follow Up (Up To 48 Months)	All randomized participants who received at least one dose of study drug with baseline and post-baseline EQ-5D 5L data.	Units on a Scale	MEAN
SECONDARY	Change From Baseline in Participant-Reported EQ-5D-5L Visual Analog Scale (VAS) Score	Baseline, Follow Up (Up To 48 Months)	All randomized participants who received at least one dose of study drug with baseline and post-baseline EQ-5D 5L data.	millimeter (mm)	MEAN

Source ClinicalTrials.gov

Results by group49

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Progression Free Survival (PFS)	8 mg/kg Ramucirumab + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine	6.47	Inter-Quartile Range 3.68 to 8.51	Months
Progression Free Survival (PFS)	80 mg Merestinib + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine	6.97	Inter-Quartile Range 4.34 to 9.79	Months
Progression Free Survival (PFS)	Pooled Placebo	6.64	Inter-Quartile Range 4.11 to 9.72	Months
Overall Survival (OS)	8 mg/kg Ramucirumab + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine	10.45	Inter-Quartile Range 8.48 to 11.76	Months
Overall Survival (OS)	80 mg Merestinib + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine	14.03	Inter-Quartile Range 11.96 to 16.36	Months
Overall Survival (OS)	Pooled Placebo	13.04	Inter-Quartile Range 11.40 to 15.31	Months
Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR): Objective Response Rate (ORR)	8 mg/kg Ramucirumab + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine	31.1	95% Confidence Interval 22.3 to 39.9	Percentage of participants
Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR): Objective Response Rate (ORR)	80 mg Merestinib + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine	19.6	95% Confidence Interval 11.9 to 27.3	Percentage of participants
Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR): Objective Response Rate (ORR)	Pooled Placebo	32.7	95% Confidence Interval 23.5 to 41.8	Percentage of participants
Percentage of Participants With a Best Overall Response of CR, PR, or Stable Disease (SD): Disease Control Rate (DCR)	8 mg/kg Ramucirumab + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine	81.1	95% Confidence Interval 73.7 to 88.6	Percentage of participants

1 to 10 of 49Source ClinicalTrials.gov

See all 49 results by group

Participant flow16

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	8 mg/kg Ramucirumab + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine	106
Overall Study	STARTED	Placebo IV + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine	52
Overall Study	STARTED	80 mg Merestinib + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine	102
Overall Study	STARTED	Placebo Oral + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine	49
Overall Study	Received at Least 1 Dose of Study Drug	8 mg/kg Ramucirumab + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine	104
Overall Study	Received at Least 1 Dose of Study Drug	Placebo IV + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine	52
Overall Study	Received at Least 1 Dose of Study Drug	80 mg Merestinib + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine	102
Overall Study	Received at Least 1 Dose of Study Drug	Placebo Oral + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine	48
Overall Study	COMPLETED	8 mg/kg Ramucirumab + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine	100
Overall Study	COMPLETED	Placebo IV + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine	47

1 to 10 of 16Source ClinicalTrials.gov

See all 16 participant flow

Adverse events2,468

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Anemia	Blood and lymphatic system disorders	8 mg/kg Ramucirumab + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine	52	104	94
other	Anemia	Blood and lymphatic system disorders	Placebo IV + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine	22	52	39
other	Anemia	Blood and lymphatic system disorders	80 mg Merestinib + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine	40	102	80
other	Anemia	Blood and lymphatic system disorders	Placebo Oral + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine	24	48	33
other	Coagulopathy	Blood and lymphatic system disorders	8 mg/kg Ramucirumab + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine	1	104	1
other	Coagulopathy	Blood and lymphatic system disorders	Placebo IV + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine	0	52	0
other	Coagulopathy	Blood and lymphatic system disorders	80 mg Merestinib + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine	0	102	0
other	Coagulopathy	Blood and lymphatic system disorders	Placebo Oral + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine	0	48	0
other	Febrile neutropenia	Blood and lymphatic system disorders	8 mg/kg Ramucirumab + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine	0	104	0
other	Febrile neutropenia	Blood and lymphatic system disorders	Placebo IV + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine	1	52	1

1 to 10 of 2,468Source ClinicalTrials.gov

See all 2,468 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	8 mg/kg Ramucirumab + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine	84	104
Total, all-cause mortality	Placebo IV + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine	34	52
Total, all-cause mortality	80 mg Merestinib + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine	71	102
Total, all-cause mortality	Placebo Oral + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine	38	48
Total, other adverse events	8 mg/kg Ramucirumab + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine	102	104
Total, other adverse events	Placebo IV + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine	49	52
Total, other adverse events	80 mg Merestinib + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine	100	102
Total, other adverse events	Placebo Oral + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine	48	48
Total, serious adverse events	8 mg/kg Ramucirumab + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine	53	104
Total, serious adverse events	Placebo IV + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine	25	52

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
34592180	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
8 mg/kg Ramucirumab + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine vs Placebo IV + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine: Number of Participants With Treatment-Emergent Anti-Ramucirumab Antibodies

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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