Trial · NCT00753714

Zactima in Non Small Cell Lung Cancer (NSCLC) ELderly Patients In Combination With or Versus Gemcitabine

NCT00753714, Phase 2, Completed, Genzyme, a Sanofi Company; results first posted 2012-09-28

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Zactima in Non Small Cell Lung Cancer (NSCLC) ELderly Patients In Combination With or Versus Gemcitabine. Trials, record NCT00753714. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00753714

On this page

Trial

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

Title: Zactima in Non Small Cell Lung Cancer (NSCLC) ELderly Patients In Combination With or Versus Gemcitabine
NCT number: NCT00753714
Status: Completed
Phases: Phase 2
Enrollment: 124 participants, actual
Lead sponsor: Genzyme, a Sanofi Company
Conditions: Non Small Cell Lung Cancer
Interventions: ZD6474, Vandetanib, Placebo to Match ZD6474, Vandetanib, Gemcitabine
First posted: 2008-09-16
Last updated: 2016-10-17
Other registries' IDs: eudract:2007-004521-22
Results first posted: 2012-09-28

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	Oct 2008- dec 2011
Secondary	Overall Survival	Oct 2008- dec 2011
Secondary	Overall Objective Response	Oct 2008- dec 2011
Secondary	Duration of Response	Oct 2008- dec 2011
Secondary	The Safety and Tolerability Profile of ZD6474 (Vandetanib) in Combination With Gemcitabine	Oct 2008- Dec 2011	The Safety and Tolerability Profile of ZD6474 (Vandetanib) in Combination With Gemcitabine is defined as the number of Adverse Events which includes any symptoms and/or Clinically Significant Laboratory or Vital Signs Abnormalities, and/or ECGs Changes

Source ClinicalTrials.gov

Outcomes5

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

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Progression Free Survival	Oct 2008- dec 2011	days	MEDIAN
SECONDARY	Overall Survival	Oct 2008- dec 2011	days	MEDIAN
SECONDARY	Overall Objective Response	Oct 2008- dec 2011	Participants	NUMBER
SECONDARY	Duration of Response	Oct 2008- dec 2011	days	MEDIAN
SECONDARY	The Safety and Tolerability Profile of ZD6474 (Vandetanib) in Combination With Gemcitabine	Oct 2008- Dec 2011	Adverse Events	NUMBER

Source ClinicalTrials.gov

Results by group10

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

Outcome	Group	Value	Spread	Units
Progression Free Survival	ZD6474 (Vandetanib),Gemcitabine	183	95% Confidence Interval 116 to 214	days
Progression Free Survival	Placebo to Match ZD6474 (Vandetanib),Gemcitabine	169	95% Confidence Interval 95 to 194	days
Overall Survival	ZD6474 (Vandetanib),Gemcitabine	262	95% Confidence Interval 170 to 356	days
Overall Survival	Placebo to Match ZD6474 (Vandetanib),Gemcitabine	305	95% Confidence Interval 214 to 355	days
Overall Objective Response	ZD6474 ( (Vandetanib),Gemcitabine	9		Participants
Overall Objective Response	Placebo to Match ZD6474 (Vandetanib),Gemcitabine	8		Participants
Duration of Response	ZD6474 (Vandetanib),Gemcitabine	225	95% Confidence Interval 175 to NA	days
Duration of Response	Placebo to Match ZD6474 (Vandetanib),Gemcitabine	214	95% Confidence Interval 124 to 232	days
The Safety and Tolerability Profile of ZD6474 (Vandetanib) in Combination With Gemcitabine	ZD6474 (Vandetanib),Gemcitabine	378		Adverse Events
The Safety and Tolerability Profile of ZD6474 (Vandetanib) in Combination With Gemcitabine	Placebo to Match ZD6474 (Vandetanib),Gemcitabine	381		Adverse Events

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	ZD6474 (Vandetanib),Gemcitabine	61
Overall Study	STARTED	Placebo to Match ZD6474 (Vandetanib),Gemcitabine	63
Overall Study	COMPLETED	ZD6474 (Vandetanib),Gemcitabine	1
Overall Study	COMPLETED	Placebo to Match ZD6474 (Vandetanib),Gemcitabine	1
Overall Study	NOT COMPLETED	ZD6474 (Vandetanib),Gemcitabine	60
Overall Study	NOT COMPLETED	Placebo to Match ZD6474 (Vandetanib),Gemcitabine	62

Source ClinicalTrials.gov

Adverse events148

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
other	pyrexia	General disorders	ZD6474 (Gemcitabine), Vandetanib	17	61
other	pyrexia	General disorders	Placebo to Match ZD6474 (Gemcitabine), Vandetanib	17	63
other	Fatigue	General disorders	ZD6474 (Gemcitabine), Vandetanib	14	61
other	Fatigue	General disorders	Placebo to Match ZD6474 (Gemcitabine), Vandetanib	15	63
other	Asthenia	General disorders	ZD6474 (Gemcitabine), Vandetanib	9	61
other	Asthenia	General disorders	Placebo to Match ZD6474 (Gemcitabine), Vandetanib	13	63
other	Dispnoea	Respiratory, thoracic and mediastinal disorders	ZD6474 (Gemcitabine), Vandetanib	13	61
other	Dispnoea	Respiratory, thoracic and mediastinal disorders	Placebo to Match ZD6474 (Gemcitabine), Vandetanib	19	63
other	Cough	Respiratory, thoracic and mediastinal disorders	ZD6474 (Gemcitabine), Vandetanib	9	61
other	Cough	Respiratory, thoracic and mediastinal disorders	Placebo to Match ZD6474 (Gemcitabine), Vandetanib	10	63

1 to 10 of 148Source ClinicalTrials.gov

See all 148 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	ZD6474 (Gemcitabine), Vandetanib
Total, all-cause mortality	Placebo to Match ZD6474 (Gemcitabine), Vandetanib
Total, other adverse events	ZD6474 (Gemcitabine), Vandetanib	59	61
Total, other adverse events	Placebo to Match ZD6474 (Gemcitabine), Vandetanib	62	63
Total, serious adverse events	ZD6474 (Gemcitabine), Vandetanib	26	61
Total, serious adverse events	Placebo to Match ZD6474 (Gemcitabine), Vandetanib	25	63

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
18165633	BACKGROUND

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 comparisons2

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

Comparison	Source
ZD6474 ( (Vandetanib),Gemcitabine vs Placebo to Match ZD6474 (Vandetanib),Gemcitabine: Overall Objective Response	Trial comparisons
ZD6474 (Gemcitabine), Vandetanib vs Placebo to Match ZD6474 (Gemcitabine), Vandetanib: serious adverse events	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.

GET https://conductscience.org/api/trials/v1/NCT00753714

GET https://conductscience.org/api/trials/v1/NCT00753714/events?page=2

API reference For AI assistants