Trial · NCT00862836

Addition of Vandetanib to Standard Therapy Pegliposomal Doxorubicin (PLD)

NCT00862836, Phase 1, Phase 2, Terminated, Genzyme, a Sanofi Company; results first posted 2012-10-11

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Addition of Vandetanib to Standard Therapy Pegliposomal Doxorubicin (PLD). Trials, record NCT00862836. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00862836

On this page

Trial

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

Title: Addition of Vandetanib to Standard Therapy Pegliposomal Doxorubicin (PLD)
NCT number: NCT00862836
Status: Terminated
Phases: Phase 1, Phase 2
Enrollment: 15 participants, actual
Lead sponsor: Genzyme, a Sanofi Company
Conditions: Ovarian Cancer
Interventions: Vandetanib
First posted: 2009-03-17
Last updated: 2016-10-10
Other registries' IDs: eudract:2008-005557-38
Results first posted: 2012-10-11

Source ClinicalTrials.gov

Registered outcomes8

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

List	Outcome	Time frame	Description
Primary	Description (on the Basis of the Safety Set): Safety and Tolerability by Means of the Incidence and Type of Adverse Events (AEs).	From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months.	Number of participants with at least 1 adverse event of grade 3 or higher (CTCAE grade 3=severe, CTCAE grade 4=life threatening/disabling, CTCAE grade 5=death, as defined by National Cancer Institute CTCAE, Version 3)
Primary	Description (on the Basis of the Safety Set): Safety and Tolerability by Means of Clinically Significant Laboratory Abnormalities.	From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months.	Number of patients with elevated liver enzymes grade 3 (CTCAE grade 3=severe, CTCAE grade 4=life threatening).
Primary	Description (on the Basis of the Safety Set): Safety and Tolerability by Means of the Incidence and Type of Adverse Events (AEs). Number of Participants With Dermatologic Skin Reactions Grade 3/4.	From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months.	Number of participants with dermatologic skin reactions grade 3/4 (CTCAE grade 3= severe, CTCAE grade 4=life threatening)
Primary	Description (on the Basis of the Safety Set): Safety and Tolerability by Means of the Incidence and Type of Adverse Events (AEs). Number of Participants With Palmar-plantar Erythrodysesthesia (PPE) Grade 3/4.	From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months.	Number of participants with palmar-plantar erythrodysesthesia (PPE) grade 3/4 (CTCAE grade 3=severe skin changes with pain, CTCAE grade 4=life threatening).
Primary	Description (on the Basis of the Safety Set): Safety and Tolerability by Means of the Incidence and Type of Adverse Events (AEs). Number of Participants With Mucositis Grade 3.	From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months.	Number of participants with mucositis grade 3 (CTCAE grade 3=severe pain interfering with oral intake)
Primary	Description (on the Basis of the Safety Set): Safety and Tolerability by Means of Clinically Significant Laboratory Abnormalities. Number of Participants With Neutropenia Grade 3/4.	From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months.	Number of participants with neutropenia grade 3/4 (CTCAE grade 3=severe, CTCAE grade 4=life threatening).
Secondary	Evaluation (for ITT Set): Clinical Activity of Once Daily Oral Vandetanib 100 mg When Added to Standard Therapy (See Above), by Assessment of Progression Free Survival (PFS).	From date of registration (Informed Consent Form completed) until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 18 months.	Progression Free Survival: Progression is defined using RECIST, as a measurable increase of at least 20% in the sum of longest diameters of target lesions or unequivocal progression of non-target lesions, or the appearance of new lesions, since baseline.
Secondary	Evaluation (for ITT Set): Clinical Activity of Once Daily Oral Vandetanib 100 mg When Added to Standard Therapy (See Above), by Assessment of Overall Survival (OS).	From date of registration (Informed Consent Form completed) until the date of death.	Median overall survival (OS)

Source ClinicalTrials.gov

Outcomes8

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

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Description (on the Basis of the Safety Set): Safety and Tolerability by Means of the Incidence and Type of Adverse Events (AEs).	From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months.	Participants	NUMBER
SECONDARY	Evaluation (for ITT Set): Clinical Activity of Once Daily Oral Vandetanib 100 mg When Added to Standard Therapy (See Above), by Assessment of Progression Free Survival (PFS).	From date of registration (Informed Consent Form completed) until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 18 months.	Months	MEDIAN
SECONDARY	Evaluation (for ITT Set): Clinical Activity of Once Daily Oral Vandetanib 100 mg When Added to Standard Therapy (See Above), by Assessment of Overall Survival (OS).	From date of registration (Informed Consent Form completed) until the date of death.	Months	MEDIAN
PRIMARY	Description (on the Basis of the Safety Set): Safety and Tolerability by Means of Clinically Significant Laboratory Abnormalities.	From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months.	Participants	NUMBER
PRIMARY	Description (on the Basis of the Safety Set): Safety and Tolerability by Means of the Incidence and Type of Adverse Events (AEs). Number of Participants With Dermatologic Skin Reactions Grade 3/4.	From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months.	Participants	NUMBER
PRIMARY	Description (on the Basis of the Safety Set): Safety and Tolerability by Means of the Incidence and Type of Adverse Events (AEs). Number of Participants With Palmar-plantar Erythrodysesthesia (PPE) Grade 3/4.	From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months.	Participants	NUMBER
PRIMARY	Description (on the Basis of the Safety Set): Safety and Tolerability by Means of the Incidence and Type of Adverse Events (AEs). Number of Participants With Mucositis Grade 3.	From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months.	Participants	NUMBER
PRIMARY	Description (on the Basis of the Safety Set): Safety and Tolerability by Means of Clinically Significant Laboratory Abnormalities. Number of Participants With Neutropenia Grade 3/4.	From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months.	Participants	NUMBER

Source ClinicalTrials.gov

Results by group8

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

Outcome	Group	Value	Spread	Units
Description (on the Basis of the Safety Set): Safety and Tolerability by Means of the Incidence and Type of Adverse Events (AEs).	Vandetanib 100 mg	9		Participants
Evaluation (for ITT Set): Clinical Activity of Once Daily Oral Vandetanib 100 mg When Added to Standard Therapy (See Above), by Assessment of Progression Free Survival (PFS).	Vandetanib 100 mg	6.7	95% Confidence Interval 0.87 to 13.73	Months
Evaluation (for ITT Set): Clinical Activity of Once Daily Oral Vandetanib 100 mg When Added to Standard Therapy (See Above), by Assessment of Overall Survival (OS).	Vandetanib 100 mg	11.1	95% Confidence Interval 2.17 to 14.93	Months
Description (on the Basis of the Safety Set): Safety and Tolerability by Means of Clinically Significant Laboratory Abnormalities.	Vandetanib 100 mg	3		Participants
Description (on the Basis of the Safety Set): Safety and Tolerability by Means of the Incidence and Type of Adverse Events (AEs). Number of Participants With Dermatologic Skin Reactions Grade 3/4.	Vandetanib 100 mg	5		Participants
Description (on the Basis of the Safety Set): Safety and Tolerability by Means of the Incidence and Type of Adverse Events (AEs). Number of Participants With Palmar-plantar Erythrodysesthesia (PPE) Grade 3/4.	Vandetanib 100 mg	5		Participants
Description (on the Basis of the Safety Set): Safety and Tolerability by Means of the Incidence and Type of Adverse Events (AEs). Number of Participants With Mucositis Grade 3.	Vandetanib 100 mg	2		Participants
Description (on the Basis of the Safety Set): Safety and Tolerability by Means of Clinically Significant Laboratory Abnormalities. Number of Participants With Neutropenia Grade 3/4.	Vandetanib 100 mg	2		Participants

Source ClinicalTrials.gov

Participant flow5

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Vandetanib 100 mg	15
Overall Study	Evaluable for Safety/Toxicity	Vandetanib 100 mg	14
Overall Study	Evaluable for Activity (Tumour Response)	Vandetanib 100 mg	10
Overall Study	COMPLETED	Vandetanib 100 mg	14
Overall Study	NOT COMPLETED	Vandetanib 100 mg	1

Source ClinicalTrials.gov

Adverse events99

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	Anaemia	Blood and lymphatic system disorders	Vandetanib 100 mg	1	14
other	Leukopenia	Blood and lymphatic system disorders	Vandetanib 100 mg	1	14
other	Neutropenia	Blood and lymphatic system disorders	Vandetanib 100 mg	1	14
other	Thrombocytopenia	Blood and lymphatic system disorders	Vandetanib 100 mg	1	14
other	Thrombocytosis	Blood and lymphatic system disorders	Vandetanib 100 mg	1	14
other	Angina pectoris	Cardiac disorders	Vandetanib 100 mg	1	14
other	Tachyarrhythmia	Cardiac disorders	Vandetanib 100 mg	1	14
other	Diarrhoea	Gastrointestinal disorders	Vandetanib 100 mg	7	14
other	Nausea	Gastrointestinal disorders	Vandetanib 100 mg	7	14
other	Constipation	Gastrointestinal disorders	Vandetanib 100 mg	4	14

1 to 10 of 99Source ClinicalTrials.gov

See all 99 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Vandetanib 100 mg
Total, other adverse events	Vandetanib 100 mg	14	14
Total, serious adverse events	Vandetanib 100 mg	3	14

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
24005613	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 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.

GET https://conductscience.org/api/trials/v1/NCT00862836

GET https://conductscience.org/api/trials/v1/NCT00862836/events?page=2

API reference For AI assistants