Trial · NCT03093870

Varlitinib in Combination With Capecitabine for Advanced or Metastatic Biliary Tract Cancer

NCT03093870, Phase 2, Phase 3, Completed, ASLAN Pharmaceuticals; results first posted 2021-08-03

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Varlitinib in Combination With Capecitabine for Advanced or Metastatic Biliary Tract Cancer. Trials, record NCT03093870. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03093870

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Trial

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

Title: Varlitinib in Combination With Capecitabine for Advanced or Metastatic Biliary Tract Cancer
NCT number: NCT03093870
Status: Completed
Phases: Phase 2, Phase 3
Enrollment: 151 participants, actual
Lead sponsor: ASLAN Pharmaceuticals
Conditions: Biliary Tract Cancer
Interventions: Varlitinib, Capecitabine, Placebo (for Varlitinib)
First posted: 2017-03-28
Last updated: 2021-08-03
Results first posted: 2021-08-03

Source ClinicalTrials.gov

Registered outcomes15

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

List	Outcome	Time frame	Description
Primary	Objective Response Rate (ORR) - Part 1	Data obtained up until progression, or until last evaluable assessment in the absence of progression, regardless of whether subjects discontinued treatment or received a subsequent therapy prior to progression, up to 2 years.	Part 1: The ORR was defined as the number (%) of subjects with ≥ 1 visit response of complete response (CR) or partial response (PR). Data obtained up until progression, or until last evaluable assessment in the absence of progression, was included in the assessment of ORR, regardless of whether subjects discontinued treatment or received a subsequent therapy prior to progression. Best overall RECIST Response (BOR) was calculated based on the overall visit responses from each RECIST assessment, i.e. the best response a subject had following randomization and prior to RECIST progression or the last evaluable assessment in the absence of RECIST progression. Categorization of BOR was based on the RECIST criteria using the following response categories: CR, PR, stable disease (SD), progressive disease (PD) and not evaluable (NE).
Primary	Progression-free Survival (PFS) - Part 1	Time from randomization until date of objective disease progression or death (by any cause in absence of disease progression) regardless of whether subject withdrew from randomized therapy or received another antitumor therapy prior to PD, up to 2 years.	Part 1: Progression-free survival (PFS) was defined as the time from randomization (or starting treatment for the Safety Lead-in) until the date of objective disease progression or death (by any cause in the absence of disease progression) regardless of whether the subject withdrew from randomized therapy or received another antitumor therapy prior to disease progression. Subjects who did not experience disease progression or died at the time of analysis were censored at the time of the latest date of assessment from their last evaluable RECIST assessment. However, if the patient progressed or died after ≥ 2 missed visits (12 weeks ± 5 days maximum), the subject was censored at the time of the latest evaluable RECIST assessment. The PFS time was based on the scan/assessment dates rather than visit dates.
Secondary	Object Response Rates (ORR) - Safety Lead-In	Data obtained up until progression, or until last evaluable assessment in absence of progression, regardless of whether subjects discontinued treatment or received a subsequent therapy prior to progression, up to 2 years.	The ORR rate was defined as the number (%) of subjects with ≥ 1 visit response of complete response (CR) or partial response (PR). Data obtained up until progression, or until last evaluable assessment in the absence of progression, was included in the assessment of ORR, regardless of whether subjects discontinued treatment or received a subsequent therapy prior to progression. In all study parts, the primary assessment of ORR was based on the Full Analysis Set (FAS).
Secondary	Overall Survival (OS) - Part 1	Time from the date of randomization until death due to any cause, up to 2 years	Part 1: Overall survival (OS) was defined as the time from the date of randomization until death due to any cause. Any subject not known to have died at the time of the data cut-off was censored based on the last recorded date on which the subject was known to be alive.
Secondary	Overall Survival (OS) - Safety Lead-In	Time from the date of randomization until death due to any cause, up to 2 years	Part 1: Overall survival (OS) was defined as the time from the date of randomization until death due to any cause. Any subject not known to have died at the time of the data cut-off was censored based on the last recorded date on which the subject was known to be alive.
Secondary	Duration of Response (DoR) - Part 1	Time from the date of first documented response until the date of documented PD or death in the absence of disease progression, up to 2 years	Part 1: Duration of response (DoR) was defined as the time from the date of first documented response until the date of documented PD or death in the absence of disease progression. The end of the response should have coincided with the date of disease progression or death from any cause used for the PFS endpoint. For Part 1, DoR was calculated based on data from the ICR of radiological data.
Secondary	Disease Control Rate DCR - Part 1	Number (%) of subjects with ≥ 1 visit response of CR or PR, or with SD for a minimum of 12 weeks (± 5 days) from randomization.	Part 1: DCR rate was defined as the number (%) of subjects with ≥ 1 visit response of CR or PR, or with SD for a minimum of 12 weeks (± 5 days) from randomization. Data obtained up until progression, or until last evaluable assessment in the absence of progression, were included in the assessment of DCR, regardless of whether subjects discontinued treatment or received a subsequent therapy prior to progression. For all study parts, the primary assessment of DCR was based on the FAS. For Part 1, DCR was calculated based on data from the ICR
Secondary	Tumor Size - Part 1	Week 12	Part 1: The percentage change from baseline in tumor size at Week 12 (%ΔTSWk12) was a secondary endpoint for Part 1 and was used to present waterfall plots of the target lesion data in the Evaluable for Response (EFR) Population
Secondary	Number of Participants With Clinically Significant Laboratory Tests- Safety Lead-in	Subject screening visit to 28 days post last study drug administration	Clinical laboratory tests (hematology, clinical chemistry, urinalysis) - Number of Participants with Clinically Significant Laboratory Tests.
Secondary	Number of Participants With Clinically Significant Laboratory Tests - Part 1	Subject screening visit to 28 days post last study drug administration	Clinical laboratory tests (hematology, clinical chemistry, urinalysis) - Number of Participants with Clinically Significant Laboratory Tests.

1 to 10 of 15Source ClinicalTrials.gov

See all 15 registered outcomes

Outcomes15

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Objective Response Rate (ORR) - Part 1	Data obtained up until progression, or until last evaluable assessment in the absence of progression, regardless of whether subjects discontinued treatment or received a subsequent therapy prior to progression, up to 2 years.		Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Progression-free Survival (PFS) - Part 1	Time from randomization until date of objective disease progression or death (by any cause in absence of disease progression) regardless of whether subject withdrew from randomized therapy or received another antitumor therapy prior to PD, up to 2 years.		Months	MEDIAN
SECONDARY	Object Response Rates (ORR) - Safety Lead-In	Data obtained up until progression, or until last evaluable assessment in absence of progression, regardless of whether subjects discontinued treatment or received a subsequent therapy prior to progression, up to 2 years.		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Overall Survival (OS) - Part 1	Time from the date of randomization until death due to any cause, up to 2 years		Months	MEDIAN
SECONDARY	Overall Survival (OS) - Safety Lead-In	Time from the date of randomization until death due to any cause, up to 2 years		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Duration of Response (DoR) - Part 1	Time from the date of first documented response until the date of documented PD or death in the absence of disease progression, up to 2 years	Kaplan Meier median is presented for DoR. At the time of reporting, there were 3 censored observations in the V+C arm, none in the P+C arm. The observed number of responders in the trial was much lower than anticipated; 9 responders in total, 6 for varlitinib and 3 for placebo. Based on results of the primary endpoints, the follow-up analysis to provide more long-term efficacy data planned for when 70% of patients had experienced an OS event was not undertaken based on pre-specified criteria.	Days	MEDIAN
SECONDARY	Disease Control Rate DCR - Part 1	Number (%) of subjects with ≥ 1 visit response of CR or PR, or with SD for a minimum of 12 weeks (± 5 days) from randomization.		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Tumor Size - Part 1	Week 12		Percentage change from Baseline	MEAN
SECONDARY	Number of Participants With Clinically Significant Laboratory Tests- Safety Lead-in	Subject screening visit to 28 days post last study drug administration	No subjects reported with any CS values across majority of the hematologic, clinical chemistry, urinalysis parameters during the Safety Lead-In of the study	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Clinically Significant Laboratory Tests - Part 1	Subject screening visit to 28 days post last study drug administration	No subjects reported with any CS values across majority of the hematologic, clinical chemistry and urinalysis parameters at the end of treatment.	Participants	COUNT_OF_PARTICIPANTS

1 to 10 of 15Source ClinicalTrials.gov

See all 15 outcomes

Results by group103

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

Outcome	Group	Category	Value	Units
Objective Response Rate (ORR) - Part 1	Varlitinib and Capecitabine	Responders - CR	0	Participants
Objective Response Rate (ORR) - Part 1	Placebo and Capecitabine	Responders - CR	0	Participants
Objective Response Rate (ORR) - Part 1	Varlitinib and Capecitabine	Responders - PR	6	Participants
Objective Response Rate (ORR) - Part 1	Placebo and Capecitabine	Responders - PR	3	Participants
Objective Response Rate (ORR) - Part 1	Varlitinib and Capecitabine	Non-Responders - SD	29	Participants
Objective Response Rate (ORR) - Part 1	Placebo and Capecitabine	Non-Responders - SD	34	Participants
Objective Response Rate (ORR) - Part 1	Varlitinib and Capecitabine	Non-Responders - PD	24	Participants
Objective Response Rate (ORR) - Part 1	Placebo and Capecitabine	Non-Responders - PD	24	Participants
Objective Response Rate (ORR) - Part 1	Varlitinib and Capecitabine	Non-Responders - NE	5	Participants
Objective Response Rate (ORR) - Part 1	Placebo and Capecitabine	Non-Responders - NE	2	Participants

1 to 10 of 103Source ClinicalTrials.gov

See all 103 results by group

Participant flow9

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Varlitinib and Capecitabine - Safety Lead-In	24
Overall Study	STARTED	Varlitinib and Capecitabine - Part 1	64
Overall Study	STARTED	Placebo and Capecitabine - Part 1	63
Overall Study	COMPLETED	Varlitinib and Capecitabine - Safety Lead-In	0
Overall Study	COMPLETED	Varlitinib and Capecitabine - Part 1	23
Overall Study	COMPLETED	Placebo and Capecitabine - Part 1	22
Overall Study	NOT COMPLETED	Varlitinib and Capecitabine - Safety Lead-In	24
Overall Study	NOT COMPLETED	Varlitinib and Capecitabine - Part 1	41
Overall Study	NOT COMPLETED	Placebo and Capecitabine - Part 1	41

Source ClinicalTrials.gov

Adverse events420

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	Nausea	Gastrointestinal disorders	Varlitinib and Capecitabine - Safety Lead-In	15	24	29
other	Nausea	Gastrointestinal disorders	Varlitinib and Capecitabine - Part 1	33	64	58
other	Nausea	Gastrointestinal disorders	Placebo and Capecitabine - Part 1	14	63	19
other	Diarrhoea	Gastrointestinal disorders	Varlitinib and Capecitabine - Safety Lead-In	13	24	31
other	Diarrhoea	Gastrointestinal disorders	Varlitinib and Capecitabine - Part 1	26	64	43
other	Diarrhoea	Gastrointestinal disorders	Placebo and Capecitabine - Part 1	16	63	19
other	Vomiting	Gastrointestinal disorders	Varlitinib and Capecitabine - Safety Lead-In	11	24	27
other	Vomiting	Gastrointestinal disorders	Varlitinib and Capecitabine - Part 1	22	64	30
other	Vomiting	Gastrointestinal disorders	Placebo and Capecitabine - Part 1	11	63	18
other	Abdominal Pain	Gastrointestinal disorders	Varlitinib and Capecitabine - Safety Lead-In	9	24	12

1 to 10 of 420Source ClinicalTrials.gov

See all 420 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Varlitinib and Capecitabine - Safety Lead-In	2	24
Total, all-cause mortality	Varlitinib and Capecitabine - Part 1	35	64
Total, all-cause mortality	Placebo and Capecitabine - Part 1	35	63
Total, other adverse events	Varlitinib and Capecitabine - Safety Lead-In	24	24
Total, other adverse events	Varlitinib and Capecitabine - Part 1	64	64
Total, other adverse events	Placebo and Capecitabine - Part 1	59	63
Total, serious adverse events	Varlitinib and Capecitabine - Safety Lead-In	13	24
Total, serious adverse events	Varlitinib and Capecitabine - Part 1	25	64
Total, serious adverse events	Placebo and Capecitabine - Part 1	27	63

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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 comparisons2

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

Comparison	Source
Varlitinib and Capecitabine vs Placebo and Capecitabine: Number of Participants With Clinically Significant Laboratory Tests - Part 1	Trial comparisons
Varlitinib and Capecitabine vs Placebo and Capecitabine: Number of Participants With Clinically Significant Change in Vital Signs and Physical Examinations - Part 1	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.

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