Trial · NCT01865747

A Study of Cabozantinib (XL184) vs Everolimus in Subjects With Metastatic Renal Cell Carcinoma

NCT01865747, Phase 3, Completed, Exelixis; results first posted 2017-07-18

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study of Cabozantinib (XL184) vs Everolimus in Subjects With Metastatic Renal Cell Carcinoma. Trials, record NCT01865747. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01865747

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Trial

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

Title: A Study of Cabozantinib (XL184) vs Everolimus in Subjects With Metastatic Renal Cell Carcinoma
NCT number: NCT01865747
Status: Completed
Phases: Phase 3
Enrollment: 658 participants, actual
Lead sponsor: Exelixis
Conditions: Renal Cell Carcinoma
Interventions: Cabozantinib tablets, Everolimus (Afinitor) tablets
First posted: 2013-05-31
Last updated: 2021-04-27
Results first posted: 2017-07-18

Source ClinicalTrials.gov

Registered outcomes3

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

List	Outcome	Time frame	Description
Primary	Progression-free Survival (PFS)	PFS is measured from the date of randomization until the date of first documented disease progression or date of death from any cause as determined by the Independent Radiology Committee (IRC) per RECIST 1.1, assessed for up to 17 months.	The primary analysis of PFS is the time from randomization to date of first documented tumor progression as determined by investigator (per RECIST 1.1 criteria) or death due to any cause, whichever occurred first. A Kaplan-Meier analysis was performed to estimate the median duration.
Secondary	Overall Survival (OS)	OS was measured from the time of randomization until 320 deaths, approximately 28 months	Overall Survival (OS) is defined as the time from randomization to the date of death. Participants that had not died were censored at last known date alive. Median OS was calculated using Kaplan-Meier estimates. Interim analyses for OS occurred after 320 deaths (78% of the total OS events needed for final analysis).
Secondary	Objective Response Rate (ORR)	ORR was assessed at 8 weeks post-randomization, every 8 weeks for 12 months, and every 12 weeks until date of disease progression or death, up to May 2015 (approximately 21 months)	Objective Response Rate (ORR) is the number of participants with a best response of complete response (CR) or partial response (PR) divided by number of randomized participants. ORR was assessed by the Independent Radiology Committee (IRC) per RECIST 1.1 which was confirmed by a subsequent visit \>= 28 days later, and was analyzed in the Intent to Treat (ITT) population at the time of the primary analysis of Progression Free Survival (PFS). The data cutoff date was 22 May 2015.

Source ClinicalTrials.gov

Outcomes3

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)	PFS is measured from the date of randomization until the date of first documented disease progression or date of death from any cause as determined by the Independent Radiology Committee (IRC) per RECIST 1.1, assessed for up to 17 months.	The pre-specified primary analysis of PFS was based on the first 375 randomized subjects (187 cabozantinib and 188 everolimus).	months	NUMBER
SECONDARY	Overall Survival (OS)	OS was measured from the time of randomization until 320 deaths, approximately 28 months	The Intent to Treat (ITT) population was used and included 658 randomized subjects (330 cabozantinib, 328 everolimus) in the second interim analysis with a cutoff date of 31 December 2015.	months	NUMBER
SECONDARY	Objective Response Rate (ORR)	ORR was assessed at 8 weeks post-randomization, every 8 weeks for 12 months, and every 12 weeks until date of disease progression or death, up to May 2015 (approximately 21 months)	The analysis of ORR was performed in the ITT population (all randomized: 330 cabozantinib, 328 everolimus) based upon response determined by Independent Radiology Committee (IRC) per RECIST 1.1.	percentage of participants	NUMBER

Source ClinicalTrials.gov

Results by group6

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

Outcome	Group	Value	Spread	Units
Progression-free Survival (PFS)	Cabozantinib (XL184)	7.4	95% Confidence Interval 5.6 to 9.1	months
Progression-free Survival (PFS)	Everolimus (Afinitor)	3.8	95% Confidence Interval 3.7 to 5.4	months
Overall Survival (OS)	Cabozantinib (XL184)	21.4	95% Confidence Interval 18.7 to NA	months
Overall Survival (OS)	Everolimus (Afinitor)	16.5	95% Confidence Interval 14.7 to 18.8	months
Objective Response Rate (ORR)	Cabozantinib (XL184)	17		percentage of participants
Objective Response Rate (ORR)	Everolimus (Afinitor)	3		percentage of participants

Source ClinicalTrials.gov

Participant flow12

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

Period	Milestone	Group	Participants
Overall Study (ITT)	STARTED	Cabozantinib (XL184)	330
Overall Study (ITT)	STARTED	Everolimus (Afinitor)	328
Overall Study (ITT)	COMPLETED	Cabozantinib (XL184)	132
Overall Study (ITT)	COMPLETED	Everolimus (Afinitor)	73
Overall Study (ITT)	NOT COMPLETED	Cabozantinib (XL184)	198
Overall Study (ITT)	NOT COMPLETED	Everolimus (Afinitor)	255
Primary Intent to Treat (PITT)	STARTED	Cabozantinib (XL184)	187
Primary Intent to Treat (PITT)	STARTED	Everolimus (Afinitor)	188
Primary Intent to Treat (PITT)	COMPLETED	Cabozantinib (XL184)	56
Primary Intent to Treat (PITT)	COMPLETED	Everolimus (Afinitor)	36

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events472

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	Events
other	Hypothyroidism	Endocrine disorders	Cabozantinib (XL184)	68	331	68
other	Hypothyroidism	Endocrine disorders	Everolimus (Afinitor)	2	322	2
other	Abdominal Pain	Gastrointestinal disorders	Cabozantinib (XL184)	50	331	50
other	Abdominal Pain	Gastrointestinal disorders	Everolimus (Afinitor)	30	322	30
other	Abdominal Pain Upper	Gastrointestinal disorders	Cabozantinib (XL184)	26	331	26
other	Abdominal Pain Upper	Gastrointestinal disorders	Everolimus (Afinitor)	7	322	7
other	Constipation	Gastrointestinal disorders	Cabozantinib (XL184)	83	331	83
other	Constipation	Gastrointestinal disorders	Everolimus (Afinitor)	61	322	61
other	Diarrhoea	Gastrointestinal disorders	Cabozantinib (XL184)	245	331	245
other	Diarrhoea	Gastrointestinal disorders	Everolimus (Afinitor)	88	322	88

1 to 10 of 472Source ClinicalTrials.gov

See all 472 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Cabozantinib (XL184)
Total, all-cause mortality	Everolimus (Afinitor)
Total, other adverse events	Cabozantinib (XL184)	328	331
Total, other adverse events	Everolimus (Afinitor)	270	322
Total, serious adverse events	Cabozantinib (XL184)	131	331
Total, serious adverse events	Everolimus (Afinitor)	139	322

Source ClinicalTrials.gov

Papers9

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
26406150	DERIVED	PubMed
27279544	DERIVED	PubMed
29309249	DERIVED	PubMed
29377755	DERIVED	PubMed
31371341	DERIVED	PubMed
31887537	DERIVED	PubMed
34364385	DERIVED	PubMed
34921022	DERIVED	PubMed
37656041	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 comparisons1

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

Comparison
Cabozantinib (XL184) vs Everolimus (Afinitor): serious adverse events

Source 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/NCT01865747

GET https://conductscience.org/api/trials/v1/NCT01865747/events?page=2

API reference For AI assistants