Trial · NCT00753675

Vandetanib Gemcitabine Or Placebo Plus Gemcitabine Or Vandetanib Monotherapy In Advanced Biliary Tract Cancer

NCT00753675, Phase 2, Completed, Genzyme, a Sanofi Company; results first posted 2013-11-28

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Vandetanib Gemcitabine Or Placebo Plus Gemcitabine Or Vandetanib Monotherapy In Advanced Biliary Tract Cancer. Trials, record NCT00753675. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00753675

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Trial

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

Title: Vandetanib Gemcitabine Or Placebo Plus Gemcitabine Or Vandetanib Monotherapy In Advanced Biliary Tract Cancer
NCT number: NCT00753675
Status: Completed
Phases: Phase 2
Enrollment: 174 participants, actual
Lead sponsor: Genzyme, a Sanofi Company
Conditions: Biliary Tract Cancer, Gallbladder Cancer, Cancer Of The Extrahepatic Bile Duct, Ampullary Carcinoma
Interventions: ZD6474, Vandetanib, ZD6474, Vandetanib, Gemcitabine, Placebo matching ZD6474
First posted: 2008-09-16
Last updated: 2016-10-10
Other registries' IDs: eudract:2007-003056-12
Results first posted: 2013-11-28

Source ClinicalTrials.gov

Registered outcomes5

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

List	Outcome	Time frame	Description
Primary	Progression Free Survival	up to 1032 days	Progression was defined as Time from the date of first dose of study medication to progression of disease, or death (it also includes patients who are lost to follow-up or have withdrawn consent) and evaluated with RECIST criteria as an increase of at least 20% in the sum of longest diameter (LD) of target lesion(s) taking as reference the smallest sum of LD since the treatment started or any new lesion(s).
Secondary	Objective Tumor Response Rate (CR+PR),	up to 1032 days	Objective Tumor Response Rate was defined as complete response (CR) + partial response (PR) evaluated by RECIST. CR was defined as disappearance of all target lesions. PR was defined as at least 30% decrease in the sum of longest diameters (LD) of target lesion(s) taking as reference the baseline sum of LD
Secondary	Disease Control Rate (CR+PR+SD)	up to 1032 days	DCR is the sum of patients with a best overall CR, PR or SD (\>=8 weeks) by the patient in the analysis
Secondary	Duration of Response (DOR)	up to 1032 days	DOR is defined from the date of first documentation of response until date of PD or death
Secondary	Overall Survival	up to 1032 days	OS is defined from the date of randomization to death

Source ClinicalTrials.gov

Outcomes5

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Progression Free Survival	up to 1032 days	ITT	days	MEDIAN
SECONDARY	Objective Tumor Response Rate (CR+PR),	up to 1032 days	ITT	Participants	NUMBER
SECONDARY	Disease Control Rate (CR+PR+SD)	up to 1032 days	ITT	Partecipants	NUMBER
SECONDARY	Duration of Response (DOR)	up to 1032 days	ITT (best response of CR or PR only)	Days	MEDIAN
SECONDARY	Overall Survival	up to 1032 days	ITT	Days	MEDIAN

Source ClinicalTrials.gov

Results by group21

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

Outcome	Group	Category	Value	Spread	Units
Progression Free Survival	Arm A Vandetanib 300 mg		105	95% Confidence Interval 72 to 155	days
Progression Free Survival	Arm B Vandetanib 100mg + Gemcitab		114	95% Confidence Interval 91 to 193	days
Progression Free Survival	ARM C Placebo+ Gemcitabine		148	95% Confidence Interval 72 to 225	days
Objective Tumor Response Rate (CR+PR),	Arm A Vandetanib 300 mg	Objective Response = NO	54		Participants
Objective Tumor Response Rate (CR+PR),	Arm B Vandetanib 100mg + Gemcitab	Objective Response = NO	46		Participants
Objective Tumor Response Rate (CR+PR),	ARM C Placebo+ Gemcitabine	Objective Response = NO	45		Participants
Objective Tumor Response Rate (CR+PR),	Arm A Vandetanib 300 mg	Objective Response = YES	2		Participants
Objective Tumor Response Rate (CR+PR),	Arm B Vandetanib 100mg + Gemcitab	Objective Response = YES	11		Participants
Objective Tumor Response Rate (CR+PR),	ARM C Placebo+ Gemcitabine	Objective Response = YES	7		Participants
Disease Control Rate (CR+PR+SD)	Arm A Vandetanib 300 mg	Disease control rate = NO	42		Partecipants

1 to 10 of 21Source ClinicalTrials.gov

See all 21 results by group

Participant flow9

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Arm A Vandetanib 300 mg	59
Overall Study	STARTED	Arm B Vandetanib 100mg + Gemcitab	59
Overall Study	STARTED	ARM C Placebo+ Gemcitabine	56
Overall Study	COMPLETED	Arm A Vandetanib 300 mg	0
Overall Study	COMPLETED	Arm B Vandetanib 100mg + Gemcitab	0
Overall Study	COMPLETED	ARM C Placebo+ Gemcitabine	0
Overall Study	NOT COMPLETED	Arm A Vandetanib 300 mg	59
Overall Study	NOT COMPLETED	Arm B Vandetanib 100mg + Gemcitab	59
Overall Study	NOT COMPLETED	ARM C Placebo+ Gemcitabine	56

Source ClinicalTrials.gov

Adverse events801

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	Arm A Vandetanib 300 mg	1	59	4
other	Anemia	Blood and lymphatic system disorders	Arm B Vandetanib 100mg + Gemcitab	10	58	20
other	Anemia	Blood and lymphatic system disorders	ARM C Placebo+ Gemcitabine	7	56	18
other	Acute Myocardial Infarction	Cardiac disorders	Arm A Vandetanib 300 mg	0	59	0
other	Acute Myocardial Infarction	Cardiac disorders	Arm B Vandetanib 100mg + Gemcitab	1	58	1
other	Acute Myocardial Infarction	Cardiac disorders	ARM C Placebo+ Gemcitabine	0	56	0
other	Abdominal Distension	Gastrointestinal disorders	Arm A Vandetanib 300 mg	1	59	1
other	Abdominal Distension	Gastrointestinal disorders	Arm B Vandetanib 100mg + Gemcitab	0	58	0
other	Abdominal Distension	Gastrointestinal disorders	ARM C Placebo+ Gemcitabine	2	56	3
other	Asthenia	General disorders	Arm A Vandetanib 300 mg	7	59	7

1 to 10 of 801Source ClinicalTrials.gov

See all 801 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Arm A Vandetanib 300 mg
Total, all-cause mortality	Arm B Vandetanib 100mg + Gemcitab
Total, all-cause mortality	ARM C Placebo+ Gemcitabine
Total, other adverse events	Arm A Vandetanib 300 mg	57	59
Total, other adverse events	Arm B Vandetanib 100mg + Gemcitab	53	58
Total, other adverse events	ARM C Placebo+ Gemcitabine	50	56
Total, serious adverse events	Arm A Vandetanib 300 mg	16	59
Total, serious adverse events	Arm B Vandetanib 100mg + Gemcitab	15	58
Total, serious adverse events	ARM C Placebo+ Gemcitabine	12	56

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
12183421	BACKGROUND	PubMed
25538178	DERIVED	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 comparisons0

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

None in this release.

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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