Trial · NCT01227928

Efficacy and Safety of Pazopanib Monotherapy After First-line Chemotherapy in Ovarian, Fallopian Tube, or Primary Peritoneal Cancer in Asian Women

NCT01227928, Phase 2, Completed, GlaxoSmithKline; results first posted 2013-06-04

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 in Asian Women. Trials, record NCT01227928. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01227928

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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 in Asian Women
NCT number: NCT01227928
Status: Completed
Phases: Phase 2
Enrollment: 145 participants, actual
Lead sponsor: GlaxoSmithKline
Conditions: Neoplasms, Ovarian
Interventions: Pazopanib, Placebo comparator
First posted: 2010-10-25
Last updated: 2015-03-03
Results first posted: 2013-06-04

Source ClinicalTrials.gov

Registered outcomes15

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

List	Outcome	Time frame	Description
Primary	Progression-free Survival (PFS)	From randomization until evidence of progressive disease or death, whichever occurred first (average of 15.2 months)	PFS is defined as the time interval between randomization and evidence of progressive disease (PD), as assessed by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0, or death, whichever occurred first. A visit-based analysis approach to determine participants' dates of progression was applied in the analysis method. PD is defined as at least a 20% increase in the sum of the longest diameter (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. Participants who were alive and had not progressed at the time of analysis were censored at the date associated with the last visit with adequate assessment.
Secondary	Overall Survival	From randomization until death due to any cause (average of 29.4 months)	Overall survival is defined as the time interval from the date of randomization to the date of death due to any cause.
Secondary	PFS by Gynaecologic Cancer Intergroup (GCIG) Criteria	From randomization to the earliest date of disease progression per GCIG criteria or death due to any cause (average of 15.2 months)	PFS by GCIG criteria is defined as the time from the randomization date to the earliest date of disease progression (PD) per GCIG criteria or death due to any cause. Per GCIG criteria, an objective progression is defined as the earliest event of either tumor progression based on RECIST v1.0 or confirmed CA-125 progression. A participant is counted as "Progressed per RECIST" if the radiological PD per RECIST occurred prior to or on the same day as CA-125 progression. A participant is counted as "Progressed per CA-125" if the radiological PD occurred after CA-125 progression. Per RECIST, PD is defined as at least a 20% increase in the sum of the 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. Participants who were alive and had not progressed at the time of analysis were censored at the date associated with the last visit with adequate assessment.
Secondary	Number of Participants With Any Dose Reduction or Any Dose Interruption	From Week 1 until the end of the treatment period (up to Study Week 108)	Dose interruptions or reductions may have been required following potential drug-related toxicities. As a general rule, if dose reduction of investigational product (IP) was necessary, the dose should have been reduced stepwise by 200 mg at each step, and the participant should have been monitored for 10 to 14 days. If toxicity recurred or worsened during this monitoring time, the IP could have been interrupted and/or the dose of IP further decreased, with continued monitoring for an additional 10 to 14 days, and so on. The cut off for these data was October 12, 2012.
Secondary	Number of Participants With Any Non-serious Adverse Event (AE) and Any Serious Adverse Event (SAE)	From Week 1 until the end of the treatment period (up to Study Week 108)	An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalizaton or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. See the non-serious AE/SAE module for a list of specific events.
Secondary	Number of Participants With Any On-therapy AE and Any AE Related to Study Treatment	From Week 1 until the end of the treatment period (up to Study Week 108)	An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. On-therapy AEs were those reported from the first day that randomized study drug was received to 28 days after the last dose of randomized study drug, and within 28 days of dose interruption. Relatedness was assessed by the Investigator.
Secondary	Number of Participants With Any Grade 3 or 4 AE	From Week 1 until the end of the treatment period (up to Study Week 108)	An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. The NCI Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 3.0 was used to grade AEs per the following scale to assess severity: Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life-threatening or disabling AE; Grade 5, death related to AE.
Secondary	Number of Participants With the Indicated On-therapy Grade 3-5 AEs	From Week 1 until the end of the treatment period (up to Study Week 108)	An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. On-therapy AEs were those reported from the first day that randomized study drug was received to 28 days after the last dose of randomized study drug, and within 28 days of dose interruption. The NCI-CTCAE Version 3.0 was used to grade AEs per the following scale to assess severity: Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life-threatening or disabling AE; Grade 5, death related to AE. ALT=alanine aminotransferase; AST=aspartate aminotransferase.
Secondary	Number of Participants With AEs Leading to Permanent Discontinuation of Study Treatment, Dose Interruption, and Dose Reduction	From Week 1 until the end of the treatment period (up to Study Week 108)	An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. Dose interruptions or reductions may have been required following potential drug-related toxicities. As a general rule, if dose reduction of investigational product (IP) was necessary, the dose should have been reduced stepwise by 200 mg at each step, and the participant should have been monitored for 10 to 14 days. If toxicity recurred or worsened during this monitoring time, the IP could have been interrupted and/or the dose of IP further decreased, with continued monitoring for an additional 10 to 14 days, and so on.
Secondary	Number of Participants With Any SAE, Any SAE Related to Study Treatment, and Any Fatal SAE	From Week 1 until the end of the treatment period (up to Study Week 108)	An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalizaton or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. See the non-serious AE/SAE module for a list of specific events. Relatedness was assessed by the Investigator.

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	Progression-free Survival (PFS)	From randomization until evidence of progressive disease or death, whichever occurred first (average of 15.2 months)	Intent-to-Treat (ITT) Population: all randomized participants who were not screen failures. Participants who were screen failures and randomized by mistake, but who did not receive study treatment, were not included. The treatment assignment in the ITT Population was based on the randomized treatment. The data cut off was October 12, 2012.	months	MEDIAN
SECONDARY	Overall Survival	From randomization until death due to any cause (average of 29.4 months)	ITT Population. Participants who were alive as of study completion were censored at the last contact date. The cut off for these data was January 10, 2014.	months	MEDIAN
SECONDARY	PFS by Gynaecologic Cancer Intergroup (GCIG) Criteria	From randomization to the earliest date of disease progression per GCIG criteria or death due to any cause (average of 15.2 months)	ITT Population. The cut off for these data was October 12, 2012.	months	MEDIAN
SECONDARY	Number of Participants With Any Dose Reduction or Any Dose Interruption	From Week 1 until the end of the treatment period (up to Study Week 108)	All Treated Population: all randomized participants who received at least one dose of investigational product. Treatment assignments in the All Treated Population were based on the actual treatment received, if different from the randomized treatment.	participants	NUMBER
SECONDARY	Number of Participants With Any Non-serious Adverse Event (AE) and Any Serious Adverse Event (SAE)	From Week 1 until the end of the treatment period (up to Study Week 108)	All Treated Population: all randomized participants who received at least one dose of investigational product. Treatment assignments in the All Treated Population were based on the actual treatment received, if different from the randomized treatment. The cut off for these data was January 10, 2014.	participants	NUMBER
SECONDARY	Number of Participants With Any On-therapy AE and Any AE Related to Study Treatment	From Week 1 until the end of the treatment period (up to Study Week 108)	All Treated Population: all randomized participants who received at least one dose of investigational product. Treatment assignments in the All Treated Population were based on the actual treatment received, if different from the randomized treatment. The cut off for these data was January 10, 2014.	participants	NUMBER
SECONDARY	Number of Participants With Any Grade 3 or 4 AE	From Week 1 until the end of the treatment period (up to Study Week 108)	All Treated Population: all randomized participants who received at least one dose of investigational product. Treatment assignments in the All Treated Population were based on the actual treatment received, if different from the randomized treatment. The cut off for these data was January 10, 2014.	participants	NUMBER
SECONDARY	Number of Participants With the Indicated On-therapy Grade 3-5 AEs	From Week 1 until the end of the treatment period (up to Study Week 108)	All Treated Population: all randomized participants who received at least one dose of investigational product. Treatment assignments in the All Treated Population were based on the actual treatment received, if different from the randomized treatment. The cut off for these data was January 10, 2014.	participants	NUMBER
SECONDARY	Number of Participants With AEs Leading to Permanent Discontinuation of Study Treatment, Dose Interruption, and Dose Reduction	From Week 1 until the end of the treatment period (up to Study Week 108)	All Treated Population: all randomized participants who received at least one dose of investigational product. Treatment assignments in the All Treated Population were based on the actual treatment received, if different from the randomized treatment. The cut off for these data was January 10, 2014.	participants	NUMBER
SECONDARY	Number of Participants With Any SAE, Any SAE Related to Study Treatment, and Any Fatal SAE	From Week 1 until the end of the treatment period (up to Study Week 108)	All Treated Population: all randomized participants who received at least one dose of investigational product. Treatment assignments in the All Treated Population were based on the actual treatment received, if different from the randomized treatment. The cut off for these data was January 10, 2014.	participants	NUMBER

1 to 10 of 15Source ClinicalTrials.gov

See all 15 outcomes

Results by group228

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

Outcome	Group	Category	Value	Spread	Units
Progression-free Survival (PFS)	Placebo		18.1	95% Confidence Interval 12.1 to NA	months
Progression-free Survival (PFS)	Pazopanib 800 Milligrams		18.1	95% Confidence Interval 18.0 to 18.1	months
Overall Survival	Placebo		NA	95% Confidence Interval NA to NA	months
Overall Survival	Pazopanib 800 Milligrams		NA	95% Confidence Interval NA to NA	months
PFS by Gynaecologic Cancer Intergroup (GCIG) Criteria	Placebo		15.2	95% Confidence Interval 9.0 to NA	months
PFS by Gynaecologic Cancer Intergroup (GCIG) Criteria	Pazopanib 800 Milligrams		16.1	95% Confidence Interval 14.2 to 18.2	months
Number of Participants With Any Dose Reduction or Any Dose Interruption	Placebo	Any Reduction	26		participants
Number of Participants With Any Dose Reduction or Any Dose Interruption	Pazopanib 800 Milligrams	Any Reduction	64		participants
Number of Participants With Any Dose Reduction or Any Dose Interruption	Placebo	Any Interruption	44		participants
Number of Participants With Any Dose Reduction or Any Dose Interruption	Pazopanib 800 Milligrams	Any Interruption	65		participants

1 to 10 of 228Source ClinicalTrials.gov

See all 228 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	72
Overall Study	STARTED	Pazopanib 800 Milligrams	73
Overall Study	COMPLETED	Placebo	50
Overall Study	COMPLETED	Pazopanib 800 Milligrams	56
Overall Study	NOT COMPLETED	Placebo	22
Overall Study	NOT COMPLETED	Pazopanib 800 Milligrams	17

Source ClinicalTrials.gov

Adverse events102

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	Hypertension	Vascular disorders	Placebo	20	72
other	Hypertension	Vascular disorders	Pazopanib 800 Milligrams	55	72
other	Neutropenia	Blood and lymphatic system disorders	Placebo	16	72
other	Neutropenia	Blood and lymphatic system disorders	Pazopanib 800 Milligrams	46	72
other	Leukopenia	Blood and lymphatic system disorders	Placebo	18	72
other	Leukopenia	Blood and lymphatic system disorders	Pazopanib 800 Milligrams	39	72
other	Thrombocytopenia	Blood and lymphatic system disorders	Placebo	4	72
other	Thrombocytopenia	Blood and lymphatic system disorders	Pazopanib 800 Milligrams	17	72
other	Diarrhoea	Gastrointestinal disorders	Placebo	5	72
other	Diarrhoea	Gastrointestinal disorders	Pazopanib 800 Milligrams	35	72

1 to 10 of 102Source ClinicalTrials.gov

See all 102 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo
Total, all-cause mortality	Pazopanib 800 Milligrams
Total, other adverse events	Placebo	59	72
Total, other adverse events	Pazopanib 800 Milligrams	72	72
Total, serious adverse events	Placebo	4	72
Total, serious adverse events	Pazopanib 800 Milligrams	7	72

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
26588236	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 comparisons2

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

Comparison	Source
Pazopanib 800 Milligrams vs Placebo: Number of Participants With Any Grade 3 or 4 AE	Trial comparisons
Pazopanib 800 Milligrams 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.

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/NCT01227928

GET https://conductscience.org/api/trials/v1/NCT01227928/results?page=2

API reference For AI assistants