Trial · NCT01259063

RAD001 and Intravesical Gemcitabine in BCG-Refractory Primary or Secondary Carcinoma In Situ of the Bladder

NCT01259063, Phase 1, Phase 2, Completed, Memorial Sloan Kettering Cancer Center; results first posted 2018-03-13

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. RAD001 and Intravesical Gemcitabine in BCG-Refractory Primary or Secondary Carcinoma In Situ of the Bladder. Trials, record NCT01259063. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01259063

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Trial

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

Title: RAD001 and Intravesical Gemcitabine in BCG-Refractory Primary or Secondary Carcinoma In Situ of the Bladder
NCT number: NCT01259063
Status: Completed
Phases: Phase 1, Phase 2
Enrollment: 33 participants, actual
Lead sponsor: Memorial Sloan Kettering Cancer Center
Conditions: Bladder Cancer
Interventions: Everolimus and Intravesical Gemcitabine
First posted: 2010-12-13
Last updated: 2018-03-13
Results first posted: 2018-03-13

Source ClinicalTrials.gov

Registered outcomes6

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

List	Outcome	Time frame	Description
Primary	Phase I - Dose-limiting Toxicity (DLT)	8 weeks	Everolimus (mg) given in conjunction with intravesical gemcitabine
Primary	Phase II - Patients Who Are Free of Disease at 1 Year	1 year	following start of therapy.
Primary	Phase I - Maximum Tolerated Dose (MTD)	8 weeks	of Everolimus given in conjunction with intravesical gemcitabine
Secondary	Complete Response (CR) Rate	1 year	Complete Response (CR) is defined as no evidence of disease (by cytology and cystoscopy). Partial Response is defined as negative cystoscopy and positive cytology. Progression is defined as the development of invasion or metastasis. If the participant develops a recurrence, they will be considered having failed treatment. Participants will also be considered having failed treatment if there is no response to treatment after two cycles.
Secondary	Survival of Patients Treated	1 year	With Everolimus in combination with intravesical gemcitabine. Overall survival following start of therapy will be estimated using Kaplan-Meier methods.
Secondary	Activated mTOR (Mammalian Target of Rapamycin) Pathway Markers as Well as Phosphatase and Tensin Homolog (PTEN) Status and Serine/Threonine Kinase (AKT) Activation Evaluation	1 year	In all pre-treatment specimens and analysis of post treatment specimens when available.

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	Phase I - Dose-limiting Toxicity (DLT)	8 weeks	14 of the 33 participants were enrolled in the Phase I portion of the protocol	DLT	NUMBER
PRIMARY	Phase II - Patients Who Are Free of Disease at 1 Year	1 year	19 participants were evaluable for Phase II.	percentage of pts disease free at 1 year	NUMBER
PRIMARY	Phase I - Maximum Tolerated Dose (MTD)	8 weeks	14 participants enrolled in Phase I	mg daily of everolimus	NUMBER
SECONDARY	Complete Response (CR) Rate	1 year		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Survival of Patients Treated	1 year		% of pts with CR who relapsed in a year	NUMBER
SECONDARY	Activated mTOR (Mammalian Target of Rapamycin) Pathway Markers as Well as Phosphatase and Tensin Homolog (PTEN) Status and Serine/Threonine Kinase (AKT) Activation Evaluation	1 year	Inability for sequencing due to inadequate amount of tissue

Source ClinicalTrials.gov

Results by group7

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

Outcome	Group	Category	Value	Spread	Units
Phase I - Dose-limiting Toxicity (DLT)	Pts Who Failed or Relapsed After Intravesical BCG		0		DLT
Phase II - Patients Who Are Free of Disease at 1 Year	Pts Who Failed or Relapsed After Intravesical BCG		21	95% Confidence Interval 0 to 43	percentage of pts disease free at 1 year
Phase I - Maximum Tolerated Dose (MTD)	Pts Who Failed or Relapsed After Intravesical BCG		10		mg daily of everolimus
Complete Response (CR) Rate	Pts Who Failed or Relapsed After Intravesical BCG	Complete Response	17		Participants
Complete Response (CR) Rate	Pts Who Failed or Relapsed After Intravesical BCG	Partial Response	8		Participants
Complete Response (CR) Rate	Pts Who Failed or Relapsed After Intravesical BCG	Did not achieve CR or PR	8		Participants
Survival of Patients Treated	Pts Who Failed or Relapsed After Intravesical BCG		21	95% Confidence Interval 0 to 43	% of pts with CR who relapsed in a year

Source ClinicalTrials.gov

Participant flow3

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Everolimus and Intravesical Gemcitabine	33
Overall Study	COMPLETED	Everolimus and Intravesical Gemcitabine	33
Overall Study	NOT COMPLETED	Everolimus and Intravesical Gemcitabine	0

Source ClinicalTrials.gov

Adverse events82

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	Hyperglycemia	Metabolism and nutrition disorders	Pts Who Failed or Relapsed After Intravesical BCG	22	33
other	Alanine aminotransferase increased	Investigations	Pts Who Failed or Relapsed After Intravesical BCG	19	33
other	Cholesterol high	Investigations	Pts Who Failed or Relapsed After Intravesical BCG	18	33
other	Aspartate aminotransferase increased	Investigations	Pts Who Failed or Relapsed After Intravesical BCG	17	33
other	Hypertriglyceridemia	Metabolism and nutrition disorders	Pts Who Failed or Relapsed After Intravesical BCG	17	33
other	Rash maculo-papular	Skin and subcutaneous tissue disorders	Pts Who Failed or Relapsed After Intravesical BCG	16	33
other	Anemia	Blood and lymphatic system disorders	Pts Who Failed or Relapsed After Intravesical BCG	14	33
other	Fatigue	General disorders	Pts Who Failed or Relapsed After Intravesical BCG	12	33
other	Renal and urinary disorders - Other, specify	Renal and urinary disorders	Pts Who Failed or Relapsed After Intravesical BCG	12	33
other	Mucositis oral	Gastrointestinal disorders	Pts Who Failed or Relapsed After Intravesical BCG	11	33

1 to 10 of 82Source ClinicalTrials.gov

See all 82 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Pts Who Failed or Relapsed After Intravesical BCG	4	33
Total, other adverse events	Pts Who Failed or Relapsed After Intravesical BCG	23	33
Total, serious adverse events	Pts Who Failed or Relapsed After Intravesical BCG	13	33

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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/NCT01259063

GET https://conductscience.org/api/trials/v1/NCT01259063/events?page=2

API reference For AI assistants