Trial · NCT00866697

Efficacy and Safety of Pazopanib Monotherapy After First Line Chemotherapy in Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

NCT00866697, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2013-12-19

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Efficacy and Safety of Pazopanib Monotherapy After First Line Chemotherapy in Ovarian, Fallopian Tube, or Primary Peritoneal Cancer. Trials, record NCT00866697. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00866697

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Trial

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

Title: Efficacy and Safety of Pazopanib Monotherapy After First Line Chemotherapy in Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
NCT number: NCT00866697
Status: Completed
Phases: Phase 3
Enrollment: 940 participants, actual
Lead sponsor: Novartis Pharmaceuticals
Conditions: Ovarian Cancer
Interventions: Pazopanib, Placebo
First posted: 2009-03-20
Last updated: 2021-02-16
Other registries' IDs: eudract:2008-004672-50
Results first posted: 2013-12-19

Source ClinicalTrials.gov

Registered outcomes19

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

List	Outcome	Time frame	Description
Primary	Investigator-assessed Progression-free Survival (PFS)	From the date of randomization until the date of progression or death due to any cause (median time of follow-up was 17.9 months for pazopanib and 12.3 months for placebo)	PFS is the interval between the date of randomization and the date of progression, defined by Response Evaluation Criteria in Solid Tumors (RECIST), or death due to any cause. Per RECIST, for target lesions (TLs), disease progression (PD) is defined as \>=20% increase in the sum of the longest diameters (LD) of TLs, taking as a reference, the smallest sum LD recorded since the treatment started or the appearance of \>=1 new lesions. For non-target lesions (NTLs), PD is defined as the appearance of \>=1 new lesions and/or unequivocal progression of existing NTLs. Participants (par.) who did not progress/die were censored at the date of last adequate assessment (LAA). Par. who started a new anti-cancer therapy (ACT) prior to radiological progression/death were censored at the date of LAA prior to the new ACT. Par. who progressed/died after an extended period (\>=12 months) without adequate assessment (AA) were censored at the date of their last visit with AA prior to progression/death.
Secondary	Overall Survival - Median	From the date of randomization until the date of death due to any cause up to approximately 25 months	Overall surival is defined as the interval between the date of randomization and the date of death due to any cause. For participants who did not die, the time to death was censored at the time of last contact.
Secondary	Overall Survival: Number of Participants Experiencing Death	From the date of randomization until the date of death due to any cause up to approximately 25 months	Overall surival is defined as the interval between the date of randomization and the date of death due to any cause. For participants who did not die, the time to death was censored at the time of last contact.
Secondary	Progression-free Survival Per Gynecologic Cancer Intergroup (GCIG) Criteria	From the date of randomization until the date of progression per GCIG criteria or death due to any cause (median time of follow-up was 16.8 months for pazopanib and 11.9 months for placebo)	Progression-free survival by GCIG criteria is defined as the time from the date of randomization to the earliest date of disease progression per GCIG criteria or death due to any cause. Progression is defined according to RECIST but can also be based upon serum CA-125. Progression or recurrence based on serum CA-125 levels are defined on the basis of a progressive serial elevation of serum CA-125, according to the following criteria: (1) participants (par.) with elevated CA-125 pretreatment and normalization of CA-125 must show evidence of CA-125 \>=2x the upper normal limit (UNL) on two occasions at least one week apart or; (2) par. with elevated CA-125 pretreatment, which never normalizes, must show evidence of CA-125 \>=2x the nadir value on two occasions at least one week apart or; (3) par. with CA-125 in the normal range pretreatment must show evidence of CA-125 \>=2x the UNL on two occasions at least one week apart.
Secondary	3-year Progression-free Survival	Up to 3 years after randomization	3-year progression-free survival is defined as the percentage of participants who are progression-free at 3 years from randomization. Progression-free survival is defined as the time from the date of randomization to the earliest date of disease progression (defined by RECIST) or death due to any cause. Per RECIST, for target lesions, disease progression (PD) is defined as at least a 20% increase in the sum of the longest diameters (LD) of target lesions, taking as a reference, the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. For non-target lesions, PD is defined as the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.
Secondary	Change From Baseline in the European Organization for the Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status Score on Day 1 of Week 13 and Months 7, 10, 13, 16, and 25	Baseline; Week 13; Months 7, 10, 13, 16, and 25	The EORTC QLQ-C30 is a self-reported, 30-item cancer-specific instrument that assesses 15 domains: 5 functional scales (physical, role, emotional, cognitive, and social functioning), 9 symptom scales (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties), and a global health status, or quality of life. Global health status is assessed using a 7-item Likert scale, ranging from 1 to 7 ("poor" to "excellent"). Participants were asked to respond to the following questions using the 7-item Likert scale: "How would you rate your overall health during the past week"; "How would you rate your overall quality of life during the past week?" Data are transformed to a scale ranging from 0 to 100. Higher scores represent better functioning (better quality of life). Mean changes from Baseline were calculated via mixed model-repeated measures analysis of covariance (ANCOVA).
Secondary	Change From Baseline in QLQ-OV-28 Module Attitude to Disease/Treatment Functional Score on Day 1 of Week 13 and Months 7, 10, 13, 16, and 25	Baseline; Week 13; Months 7, 10, 13, 16, and 25	The OV (ovarian)-28 module is a 28-item addition to the EORTC QLQ-C30 that focuses on issues specific to ovarian cancer. It assesses attitude to disease/treatment functional symptoms, among others. Participants were asked to indicate the extent to which they experienced attention to disease/treatment functional problems in the week prior to assessment. Participants responded on a scale of 1-4 (1=not at all, 2=a little, 3=quite a bit, 4=very much) to the following questions: How much has your disease been a burden to you?; How much has your treatment been a burden to you?; Were you worried about your future health? Data are transformed to a scale ranging from 0 to 100. Higher scores represent better functioning (better quality of life). Mean changes from Baseline were calculated via mixed model-repeated measures ANCOVA.
Secondary	Change From Baseline in QLQ-OV-28 Module Body Image Functional Score on Day 1 of Week 13 and Months 7, 10, 13, 16, and 25	Baseline; Week 13; Months 7, 10, 13, 16, and 25	The OV-28 module is a 28-item addition to the EORTC QLQ-C30 that focuses on issues specific to ovarian cancer. It assesses body image symptoms, among others. Participants were asked to indicate the extent to which they experienced body image problems in the week prior to assessment. Participants responded on a scale of 1-4 (1=not at all, 2=a little, 3=quite a bit, 4=very much) to the following questions: Have you felt physically less attractive as a result of your disease or treatment?; Have you been dissatisfied with your body? Data are transformed to a scale ranging from 0 to 100. Higher scores represent better functioning (better quality of life). Mean changes from Baseline were calculated via mixed model-repeated measures ANCOVA.
Secondary	Change From Baseline in QLQ-OV-28 Module Peripheral Neuropathy (PN) Symptoms Score at Week 13 and Months 7, 10, 13, 16, and 25	Baseline; Week 13; Months 7, 10, 13, 16, and 25	The OV-28 module is a 28-item addition to the EORTC QLQ-C30 that focuses on issues specific to ovarian cancer. It assesses peripheral neuropathy symptoms, among others. Participants were asked to indicate the extent to which they experienced peripheral neuropathy symptoms or problems in the week prior to assessment. Participants responded on a scale of 1-4 (1=not at all, 2=a little, 3=quite a bit, 4=very much) to the following questions: Did you have tingling hands or feet?; Have you had numbness in your fingers or toes?; Have you felt weak in your arms or legs? Data are transformed to a scale from 0 to 100. Lower scores represent better health (fewer symptoms) for symptom scales. Mean changes from Baseline were calculated via mixed model-repeated measures ANCOVA.
Secondary	Change From Baseline in QLQ-OV-28 Module Abdominal (AB)/Gastrointestinal (GI) Symptoms Score at Week 13 and Months 7, 10, 13, 16, and 25	Baseline; Week 13; Months 7, 10, 13, 16, and 25	The OV-28 module is a 28-item addition to the EORTC QLQ-C30 that focuses on issues specific to ovarian cancer. It assesses AB/GI symptoms, among others. Participants were asked to indicate the extent to which they experienced AB/GI symptoms or problems in the week prior to assessment. Participants responded on a scale of 1-4 (1=not at all, 2=a little, 3=quite a bit, 4=very much) to the following questions: Did you have abdominal pain?; Did you have a bloated feeling in your abdomen/stomach?; Did you have problems with your clothes feeling too tight?; Did you experience any change in bowel habit as a result of your disease or treatment?; Were you troubled by passing wind/gas/flatulence?; Have you felt full too quickly after beginning to eat?; Have you had indigestion/heartburn? Data are transformed to a scale from 0 to 100. Lower scores represent better health (fewer symptoms) for symptom scales. Mean changes from Baseline were calculated via mixed model-repeated measures ANCOVA.

1 to 10 of 19Source ClinicalTrials.gov

See all 19 registered outcomes

Outcomes20

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Investigator-assessed Progression-free Survival (PFS)	From the date of randomization until the date of progression or death due to any cause (median time of follow-up was 17.9 months for pazopanib and 12.3 months for placebo)	Intent-to-Treat (ITT) Population: all randomized participants	months	MEDIAN
SECONDARY	Overall Survival - Median	From the date of randomization until the date of death due to any cause up to approximately 25 months	Intent-to-Treat (ITT) Population: all randomized participants	months	MEDIAN
SECONDARY	Overall Survival: Number of Participants Experiencing Death	From the date of randomization until the date of death due to any cause up to approximately 25 months	Intent-to-Treat (ITT) Population: all randomized participants	participants	NUMBER
SECONDARY	Progression-free Survival Per Gynecologic Cancer Intergroup (GCIG) Criteria	From the date of randomization until the date of progression per GCIG criteria or death due to any cause (median time of follow-up was 16.8 months for pazopanib and 11.9 months for placebo)	Intent-to-Treat (ITT) Population: all randomized participants.~For participants who did not progress or die, progression-free survival was censored at the time of the last adequate disease assessment.	months	MEDIAN
SECONDARY	3-year Progression-free Survival	Up to 3 years after randomization	Intent-to-Treat (ITT) Population: all randomized participants.	percentage of participants	NUMBER
SECONDARY	Change From Baseline in the European Organization for the Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status Score on Day 1 of Week 13 and Months 7, 10, 13, 16, and 25	Baseline; Week 13; Months 7, 10, 13, 16, and 25	ITT Population. Only those participants available at the specified time points were analyzed.	scores on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in QLQ-OV-28 Module Attitude to Disease/Treatment Functional Score on Day 1 of Week 13 and Months 7, 10, 13, 16, and 25	Baseline; Week 13; Months 7, 10, 13, 16, and 25	ITT Population. Only those participants available at the specified time points were analyzed.	scores on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in QLQ-OV-28 Module Body Image Functional Score on Day 1 of Week 13 and Months 7, 10, 13, 16, and 25	Baseline; Week 13; Months 7, 10, 13, 16, and 25	ITT Population. Only those participants available at the specified time points were analyzed.	scores on a scale	MEAN
SECONDARY	Change From Baseline in QLQ-OV-28 Module Peripheral Neuropathy (PN) Symptoms Score at Week 13 and Months 7, 10, 13, 16, and 25	Baseline; Week 13; Months 7, 10, 13, 16, and 25	ITT Population. Only those participants available at the specified time points were analyzed.	scores on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in QLQ-OV-28 Module Abdominal (AB)/Gastrointestinal (GI) Symptoms Score at Week 13 and Months 7, 10, 13, 16, and 25	Baseline; Week 13; Months 7, 10, 13, 16, and 25	ITT Population. Only those participants available at the specified time points were analyzed.	scores on a scale	LEAST_SQUARES_MEAN

1 to 10 of 20Source ClinicalTrials.gov

See all 20 outcomes

Results by group348

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

Outcome	Group	Category	Value	Spread	Units
Investigator-assessed Progression-free Survival (PFS)	Placebo		12.3	95% Confidence Interval 11.8 to 17.7	months
Investigator-assessed Progression-free Survival (PFS)	Pazopanib 800 mg		17.9	95% Confidence Interval 15.9 to 21.8	months
Overall Survival - Median	Placebo		64.0	95% Confidence Interval 56.0 to 75.7	months
Overall Survival - Median	Pazopanib 800 mg		59.1	95% Confidence Interval 53.5 to 71.6	months
Overall Survival: Number of Participants Experiencing Death	Placebo	deaths	253		participants
Overall Survival: Number of Participants Experiencing Death	Pazopanib 800 mg	deaths	241		participants
Overall Survival: Number of Participants Experiencing Death	Placebo	censored, follow up ended (no deaths)	215		participants
Overall Survival: Number of Participants Experiencing Death	Pazopanib 800 mg	censored, follow up ended (no deaths)	231		participants
Progression-free Survival Per Gynecologic Cancer Intergroup (GCIG) Criteria	Placebo		11.9	95% Confidence Interval 10.6 to 14.9	months
Progression-free Survival Per Gynecologic Cancer Intergroup (GCIG) Criteria	Pazopanib 800 mg		16.8	95% Confidence Interval 12.6 to 18.1	months

1 to 10 of 348Source ClinicalTrials.gov

See all 348 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	468
Overall Study	STARTED	Pazopanib 800 mg	472
Overall Study	COMPLETED	Placebo	254
Overall Study	COMPLETED	Pazopanib 800 mg	244
Overall Study	NOT COMPLETED	Placebo	214
Overall Study	NOT COMPLETED	Pazopanib 800 mg	228

Source ClinicalTrials.gov

Adverse events360

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	Leukopenia	Blood and lymphatic system disorders	Placebo	5	461
other	Leukopenia	Blood and lymphatic system disorders	Pazopanib	44	477
other	Neutropenia	Blood and lymphatic system disorders	Placebo	23	461
other	Neutropenia	Blood and lymphatic system disorders	Pazopanib	103	477
other	Thrombocytopenia	Blood and lymphatic system disorders	Placebo	8	461
other	Thrombocytopenia	Blood and lymphatic system disorders	Pazopanib	48	477
other	Hypothyroidism	Endocrine disorders	Placebo	15	461
other	Hypothyroidism	Endocrine disorders	Pazopanib	49	477
other	Abdominal pain	Gastrointestinal disorders	Placebo	94	461
other	Abdominal pain	Gastrointestinal disorders	Pazopanib	88	477

1 to 10 of 360Source ClinicalTrials.gov

See all 360 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	0	461
Total, all-cause mortality	Pazopanib	3	477
Total, other adverse events	Placebo	381	461
Total, other adverse events	Pazopanib	462	477
Total, serious adverse events	Placebo	51	461
Total, serious adverse events	Pazopanib	121	477

Source ClinicalTrials.gov

Papers7

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
25225436	DERIVED	PubMed
25434635	DERIVED	PubMed
26588236	DERIVED	PubMed
27769273	DERIVED	PubMed
29267856	DERIVED	PubMed
31519320	DERIVED	PubMed
37185961	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 comparisons2

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

Comparison	Source
Pazopanib vs Placebo: deaths from any cause	Trial comparisons
Pazopanib vs Placebo: 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.

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Read this trial from software.

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

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