Trial · NCT00726323

A Phase II Study of GSK1363089 (Formerly XL880) for Papillary Renal-Cell Carcinoma (PRC)

NCT00726323, Phase 2, Completed, GlaxoSmithKline; results first posted 2017-12-11

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Phase II Study of GSK1363089 (Formerly XL880) for Papillary Renal-Cell Carcinoma (PRC). Trials, record NCT00726323. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00726323

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Trial

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

Title: A Phase II Study of GSK1363089 (Formerly XL880) for Papillary Renal-Cell Carcinoma (PRC)
NCT number: NCT00726323
Status: Completed
Phases: Phase 2
Enrollment: 74 participants, actual
Lead sponsor: GlaxoSmithKline
Conditions: Carcinoma, Renal Cell
Interventions: foretinib (formerly GSK1363089 or XL880)
First posted: 2008-07-31
Last updated: 2017-12-11
Results first posted: 2017-12-11

Source ClinicalTrials.gov

Registered outcomes10

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

List	Outcome	Time frame	Description
Primary	Overall Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Criteria Version 1.0	At the end of forth year	Overall response rate is the percentage of participants for whom the best overall response to the study drug was a confirmed partial response (PR) or confirmed complete response (CR). Best overall response and its associated confirmation criteria, RECIST; Version 1.0) was based on the Investigator's assessment of the target and non target lesions.
Secondary	Disease Stabilization Rate Over Period	Up to 4 years	The percentage of participants for whom the best overall response was a confirmed PR, confirmed CR, or stable disease. Exact confidence intervals were obtained using the Clopper-Pearson method. Exact confidence intervals were obtained using the Clopper-Pearson method.
Secondary	Progression Free Survival (PFS)	At the end of forth year	Progression free survival is defined as the time between the date of first dose of study drug and the date of the first occurrence of either tumor progression per RECIST or clinical assessment of progression as assessed by Investigator or Death due to any cause, whichever occurs the first. For participants who did not reach an event (disease progression or death) at the time of data cutoff, PFS was censored at the date of the last available tumor measurement. For participants who did not have any post-baseline tumor assessments, PFS was right censored at Day 1. For any participants who received subsequent anticancer therapy, PFS was right censored at the date of last adequate tumor assessment on or prior to the date of anticancer initiation. For any participants, who died or progressed after an extended follow-up, PFS was censored at the date of last adequate assessment prior to the extended loss to follow-up.
Secondary	Time to Response (TTR) Over Period	Up to 4 years	Time to response is the time between the date of first dose of study drug and the date of first response (for participants who had overall responses that were later confirmed as CR/PR). For the 6 participants in the daily dosing cohort who did not reach a response as of data cutoff, the time to response was censored at the date of the last visit. The median time to response was not estimable in either of the dosing cohorts or in the overall safety population using the Kaplan-Meier method.
Secondary	Duration of Response (DOR)	Up to 4 years	Duration of response is defined as the time between the date of first response (later confirmed CR or confirmed PR) and the date of the first occurrence of one of the events as tumor progression per RECIST as assessed by Investigator, termination of the study drug due to disease progression, death due to any cause, disease progression as documented on the follow-up or participant status form Initiation of subsequent anticancer therapy. For the 6 participants in the daily dosing cohort who did not reach a response as of data cutoff, the duration of response was censored at the date of the last available tumor measurement.
Secondary	Duration of Stable Disease (SD)	Up to 4 years	Duration of SD is defined as the time between the date of first dose of study drug and the date of the first occurrence of one of the tumor progression per RECIST as assessed by Investigator, termination of the study drug due to disease progression, death due to disease progression, or disease progression as documented on the follow-up participants status form Initiation of subsequent anticancer therapy. For the 6 participants in the daily dosing cohort who did not reach a response as of data cutoff, the duration of stable disease was right censored at the date of the last available tumor measurement.
Secondary	Overall Survival	Up to 4 years	Overall survival, which is defined as the time between the date of first dose of study drug and the date of death (due to any cause). For participants who were alive at the time of data cutoff, duration of overall survival was right censored at the date of last contact. Duration of overall survival = date of death/censoring - date of first dose +1. Percentiles and confidence intervals are calculated using Kaplan-Meier methods.
Secondary	Number of Participants With Change in Common Terminology Criteria for Adverse Events (CTCAE) Grade of Clinical Chemistry Parameters Over Period	Up to 4 years	The worst case overall common terminology criteria for adverse events (CTCAE) grade shift post Baseline for each parameter was mentioned. Only worst case scenarios are presented. CTCAE grading was done as per intensity namely mild moderate severe life-threatening or Death. Analysis was done for Alanine aminotransferases (ALT), aspartate aminotransferases (AST), Albumin, alkaline phosphatase (ALP), calcium, sodium, potassium, glucose, amylase, carbon dioxide, phosphate, gamma glutamyl transferases (GGT), and triglycerol lipase. High (H) levels and low (L) levels were measured.
Secondary	Number of Participants With Change in CTCAE Grade of Hematological Parameters Over Period (Only Worst Case)	Up to 4 years	CTCAE gradation The worst case overall CTCAE grade shift post Baseline for each parameter was mentioned. Only worst case scenarios are presented. CTCAE grading was done as per intensity namely mild moderate severe life-threatening or Death. Participants were analyzed for hemoglobin, leukocytes, platelets, percentage of lymphocytes, and percentage of neutrophils.
Secondary	Number of Participants With Adverse Events, Serious Adverse Events, and Deaths	Up to 4 years	Adverse event (AE) is an unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain time period after the study has ended. This change may or may not be caused by the intervention being studied. Serious adverse event (SAE) is an adverse event that results in death, is life-threatening, requires inpatient hospitalization or extends a current hospital stay, results in an ongoing or significant incapacity or interferes substantially with normal life functions, or causes a congenital anomaly or birth defect. Medical events that do not result in death, are not life-threatening, or do not require hospitalization may be considered serious adverse events if they put the participant in danger or require medical or surgical intervention to prevent one of the results listed above.

Source ClinicalTrials.gov

Outcomes10

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Overall Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Criteria Version 1.0	At the end of forth year	The Safety population included all participants who passed the screening criteria, were enrolled in the study and received at least one dose of the study drug.	Percentage of participants	NUMBER
SECONDARY	Disease Stabilization Rate Over Period	Up to 4 years	Safety population	Percentage of participants	NUMBER
SECONDARY	Progression Free Survival (PFS)	At the end of forth year	Safety population	Months	MEDIAN
SECONDARY	Time to Response (TTR) Over Period	Up to 4 years	Safety population	Months	MEDIAN
SECONDARY	Duration of Response (DOR)	Up to 4 years	Safety Population- All Objective Responders (those who did not reach an event by the time of data cut-off as defined in protocol)	Months	MEDIAN
SECONDARY	Duration of Stable Disease (SD)	Up to 4 years	Safety population. All participants with Best overall response, not progressive disease were considered.	Months	MEDIAN
SECONDARY	Overall Survival	Up to 4 years	Safety population	Months	MEDIAN
SECONDARY	Number of Participants With Change in Common Terminology Criteria for Adverse Events (CTCAE) Grade of Clinical Chemistry Parameters Over Period	Up to 4 years	Safety population	Participants	NUMBER
SECONDARY	Number of Participants With Change in CTCAE Grade of Hematological Parameters Over Period (Only Worst Case)	Up to 4 years	Safety population	Participants	NUMBER
SECONDARY	Number of Participants With Adverse Events, Serious Adverse Events, and Deaths	Up to 4 years	Safety population	Participants	NUMBER

Source ClinicalTrials.gov

Results by group208

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

Outcome	Group	Value	Spread	Units
Overall Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Criteria Version 1.0	Intermittent 5 & 9 Dosing Regimen	13.5	95% Confidence Interval 4.5 to 28.8	Percentage of participants
Overall Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Criteria Version 1.0	Daily Dosing Regimen	13.5	95% Confidence Interval 4.5 to 28.8	Percentage of participants
Disease Stabilization Rate Over Period	Intermittent 5 & 9 Dosing Regimen	91.9	95% Confidence Interval 78.1 to 98.3	Percentage of participants
Disease Stabilization Rate Over Period	Daily Dosing Regimen	83.8	95% Confidence Interval 68.0 to 93.8	Percentage of participants
Progression Free Survival (PFS)	Intermittent 5 & 9 Dosing Regimen	11.56	95% Confidence Interval 5.78 to 16.99	Months
Progression Free Survival (PFS)	Daily Dosing Regimen	9.07	95% Confidence Interval 5.78 to 10.91	Months
Time to Response (TTR) Over Period	Intermittent 5 & 9 Dosing Regimen	NA	95% Confidence Interval 22.05 to NA	Months
Time to Response (TTR) Over Period	Daily Dosing Regimen	NA	95% Confidence Interval 12.88 to NA	Months
Duration of Response (DOR)	Intermittent 5 & 9 Dosing Regimen	20.50	95% Confidence Interval 5.55 to 20.50	Months
Duration of Response (DOR)	Daily Dosing Regimen	18.46	95% Confidence Interval 5.55 to 18.46	Months

1 to 10 of 208Source ClinicalTrials.gov

See all 208 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Intermittent 5 & 9 Dosing Regimen	37
Overall Study	STARTED	Daily Dosing Regimen	37
Overall Study	COMPLETED	Intermittent 5 & 9 Dosing Regimen	0
Overall Study	COMPLETED	Daily Dosing Regimen	6
Overall Study	NOT COMPLETED	Intermittent 5 & 9 Dosing Regimen	37
Overall Study	NOT COMPLETED	Daily Dosing Regimen	31

Source ClinicalTrials.gov

Adverse events354

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	Diarrhoea	Gastrointestinal disorders	Intermittent 5 & 9 Dosing Regimen	21	37
other	Diarrhoea	Gastrointestinal disorders	Daily Dosing Regimen	29	37
other	Nausea	Gastrointestinal disorders	Intermittent 5 & 9 Dosing Regimen	28	37
other	Nausea	Gastrointestinal disorders	Daily Dosing Regimen	19	37
other	Vomiting	Gastrointestinal disorders	Intermittent 5 & 9 Dosing Regimen	22	37
other	Vomiting	Gastrointestinal disorders	Daily Dosing Regimen	13	37
other	Constipation	Gastrointestinal disorders	Intermittent 5 & 9 Dosing Regimen	14	37
other	Constipation	Gastrointestinal disorders	Daily Dosing Regimen	11	37
other	Flatulence	Gastrointestinal disorders	Intermittent 5 & 9 Dosing Regimen	9	37
other	Flatulence	Gastrointestinal disorders	Daily Dosing Regimen	5	37

1 to 10 of 354Source ClinicalTrials.gov

See all 354 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Intermittent 5 & 9 Dosing Regimen	14	37
Total, all-cause mortality	Daily Dosing Regimen	6	37
Total, other adverse events	Intermittent 5 & 9 Dosing Regimen	37	37
Total, other adverse events	Daily Dosing Regimen	37	37
Total, serious adverse events	Intermittent 5 & 9 Dosing Regimen	20	37
Total, serious adverse events	Daily Dosing Regimen	22	37

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
23213094	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
Intermittent 5 & 9 Dosing Regimen vs Daily Dosing Regimen: deaths from any cause	Trial comparisons
Intermittent 5 & 9 Dosing Regimen vs Daily Dosing Regimen: 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/NCT00726323

GET https://conductscience.org/api/trials/v1/NCT00726323/results?page=2

API reference For AI assistants