Trial · NCT00688753

RAPTOR: RAD001 as Monotherapy in the Treatment of Advanced Papillary Renal Cell Tumors Program in Europe

NCT00688753, Phase 2, Completed, Novartis Pharmaceuticals; results first posted 2015-11-26

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. RAPTOR: RAD001 as Monotherapy in the Treatment of Advanced Papillary Renal Cell Tumors Program in Europe. Trials, record NCT00688753. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00688753

On this page

Trial

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

Title: RAPTOR: RAD001 as Monotherapy in the Treatment of Advanced Papillary Renal Cell Tumors Program in Europe
NCT number: NCT00688753
Status: Completed
Phases: Phase 2
Enrollment: 92 participants, actual
Lead sponsor: Novartis Pharmaceuticals
Conditions: Carcinoma, Renal Cell, Non Clear Cell Renal Carcinoma, Papillary Cell Renal Carcinoma, Adenocarcinoma
Interventions: RAD001
First posted: 2008-06-03
Last updated: 2016-09-02
Results first posted: 2015-11-26

Source ClinicalTrials.gov

Registered outcomes6

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

List	Outcome	Time frame	Description
Primary	To Evaluate Efficacy of RAD001 as Monotherapy for the Treatment of Papillary Renal Cancer. Efficacy is Defined as the Percentage of Patients Progression-free at 6 Months.	6 mos	PFSR at 6 months based on central review
Secondary	Disease Control Rate (SD + PR + CR)	6 mos	DCR was defined as the proportion of patients with a best overall response of CR, PR or SD and ORR as the percentage of patients with CR or PR
Secondary	Objective Response Rate	End of trial	ORR is defined as the proportion of patients with tumor size reduction of a predefined amount and for a minimum time period. Response duration usually is measured from the time of initial response until documented tumor progression
Secondary	Duration of Response	End of trial	The DOR analysis applied only to patients whose overall response was CR or PR and was defined as the time from onset of response (CR/PR) to progression or death from any cause.
Secondary	Median Progression Free Survival	End of trial	PFS was defined as the time from first study drug administration to objective tumor progression or death from any cause.
Secondary	Incidence of Adverse Events, Serious Adverse Events, and Death.	End of trial

Source ClinicalTrials.gov

Outcomes6

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	To Evaluate Efficacy of RAD001 as Monotherapy for the Treatment of Papillary Renal Cancer. Efficacy is Defined as the Percentage of Patients Progression-free at 6 Months.	6 mos	PP, PPFF, ITT	% participants	NUMBER
SECONDARY	Disease Control Rate (SD + PR + CR)	6 mos	PP,ITT	% Participants	NUMBER
SECONDARY	Objective Response Rate	End of trial		% participants	NUMBER
SECONDARY	Duration of Response	End of trial	In the final analysis, for central review, the DOR could not be calculated as only 1 patient in the PP and ITT sets met the criteria	days	MEDIAN
SECONDARY	Median Progression Free Survival	End of trial		days	MEDIAN
SECONDARY	Incidence of Adverse Events, Serious Adverse Events, and Death.	End of trial	Safety Set	% participants	NUMBER

Source ClinicalTrials.gov

Results by group20

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

Outcome	Group	Category	Value	Spread	Units
To Evaluate Efficacy of RAD001 as Monotherapy for the Treatment of Papillary Renal Cancer. Efficacy is Defined as the Percentage of Patients Progression-free at 6 Months.	RAD001	(PPFF Set, N=44)	34.1	80% Confidence Interval 24.5 to 44.8	% participants
To Evaluate Efficacy of RAD001 as Monotherapy for the Treatment of Papillary Renal Cancer. Efficacy is Defined as the Percentage of Patients Progression-free at 6 Months.	RAD001	(PPSet, N=66)	33.3	80% Confidence Interval 25.6 to 41.8	% participants
To Evaluate Efficacy of RAD001 as Monotherapy for the Treatment of Papillary Renal Cancer. Efficacy is Defined as the Percentage of Patients Progression-free at 6 Months.	RAD001	(ITT Set, N=86)	32.6	80% Confidence Interval 25.9 to 39.9	% participants
Disease Control Rate (SD + PR + CR)	RAD001	PP set	65.2	90% Confidence Interval 54.4 to 74.9	% Participants
Disease Control Rate (SD + PR + CR)	RAD001	ITT set	65.1	90% Confidence Interval 55.8 to 73.6	% Participants
Objective Response Rate	RAD001	PP Set	1.5	90% Confidence Interval 0.1 to 7.0	% participants
Objective Response Rate	RAD001	ITT Set	1.2	90% Confidence Interval 0.1 to 5.4	% participants
Duration of Response	RAD001	local review PP set	169	95% Confidence Interval 64 to 169	days
Duration of Response	RAD001	local review ITT set	226	95% Confidence Interval 64 to 928	days
Median Progression Free Survival	RAD001	PP set	118	95% Confidence Interval 65 to 174	days

1 to 10 of 20Source ClinicalTrials.gov

See all 20 results by group

Participant flow3

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

Period	Milestone	Group	Participants
Overall Study	STARTED	RAD001	92
Overall Study	COMPLETED	RAD001	0
Overall Study	NOT COMPLETED	RAD001	92

Source ClinicalTrials.gov

Adverse events124

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	All Patients	25	92
other	Thrombocytopenia	Blood and lymphatic system disorders	All Patients	10	92
other	Tachycardia	Cardiac disorders	All Patients	6	92
other	Abdominal pain	Gastrointestinal disorders	All Patients	23	92
other	Aphthous stomatitis	Gastrointestinal disorders	All Patients	11	92
other	Ascites	Gastrointestinal disorders	All Patients	5	92
other	Constipation	Gastrointestinal disorders	All Patients	15	92
other	Diarrhoea	Gastrointestinal disorders	All Patients	36	92
other	Dry mouth	Gastrointestinal disorders	All Patients	8	92
other	Nausea	Gastrointestinal disorders	All Patients	27	92

1 to 10 of 124Source ClinicalTrials.gov

See all 124 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	All Patients
Total, other adverse events	All Patients	90	92
Total, serious adverse events	All Patients	43	92

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
27680407	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/NCT00688753

GET https://conductscience.org/api/trials/v1/NCT00688753/events?page=2

API reference For AI assistants