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mTOR inhibitor

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

New York, NY
Phase 1 & 2
Waitlist Available
Led By Guido Dalbagni, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
All Individual Drugs Already Approved
Approved for 20 Other Conditions
No Placebo-Only Group

Summary

The purpose of this study is to test the safety of gemcitabine applied to the bladder directly combined with different oral doses of everolimus and to assess the right doses. Gemcitabine will be given at a fixed dose. Up to 3 dose levels of everolimus will be evaluated. The purpose of the phase II part is to test the combination of gemcitabine applied to the bladder directly combined with different oral doses of everolimus and to study the effects of these two drugs together. The investigators want to find out what effects, good and/or bad, this treatment has on the patient and the cancer.

See full description
Eligible Conditions
  • Bladder Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Phase I - Dose-limiting Toxicity (DLT)
Phase I - Maximum Tolerated Dose (MTD)
Phase II - Patients Who Are Free of Disease at 1 Year
Secondary study objectives
Activated mTOR (Mammalian Target of Rapamycin) Pathway Markers as Well as Phosphatase and Tensin Homolog (PTEN) Status and Serine/Threonine Kinase (AKT) Activation Evaluation
Complete Response (CR) Rate
Survival of Patients Treated

Side effects data

From 2017 Phase 1 & 2 trial • 33 Patients • NCT01259063
67%
Hyperglycemia
58%
Alanine aminotransferase increased
55%
Cholesterol high
52%
Aspartate aminotransferase increased
52%
Hypertriglyceridemia
48%
Rash maculo-papular
42%
Anemia
36%
Renal and urinary disorders - Other, specify
36%
Fatigue
33%
Platelet count decreased
33%
Mucositis oral
27%
Hypernatremia
27%
Cough
24%
Diarrhea
24%
Headache
24%
Hypoalbuminemia
24%
Dysgeusia
24%
White blood cell decreased
21%
Alkaline phosphatase increased
21%
Creatinine increased
18%
Hypocalcemia
18%
Hyperkalemia
18%
Urinary frequency
18%
Dry skin
15%
Erythema multiforme
15%
Skin & subcutaneous tissue disorders Other, spec
15%
Edema limbs
15%
Endocrine disorders - Other, specify
15%
Hypophosphatemia
15%
Weight loss
12%
Cystitis noninfective
12%
Gastrointestinal disorders - Other, specify
12%
Burn
12%
Fever
9%
Rash acneiform
9%
Blood bilirubin increased
9%
Dyspnea
9%
Lymphocyte count decreased
9%
Flatulence
9%
Gastroesophageal reflux disease
9%
Hematuria
9%
Dry mouth
6%
Urinary incontinence
6%
Abdominal pain
6%
Hyponatremia
6%
Urinary tract pain
6%
Flu like symptoms
6%
Productive cough
6%
Pruritus
6%
Anorexia
6%
Sore throat
6%
Hypokalemia
6%
INR increased
6%
Nausea
6%
Urinary urgency
6%
Flank pain
6%
Gen disorders & admin site conditions Other, spec
6%
Hypertension
3%
Generalized muscle weakness
3%
Pneumonitis
3%
Abdominal distension
3%
Chills
3%
Dehydration
3%
Hepatobiliary disorders - Other, specify
3%
Injury/poison & proced complications Other, spec
3%
Ejection fraction decreased
3%
Gastric ulcer
3%
Myocardial infarction
3%
Vomiting
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pts Who Failed or Relapsed After Intravesical BCG

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 20 Other Conditions
This treatment demonstrated efficacy for 20 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Pts who failed or relapsed after intravesical BCGExperimental Treatment1 Intervention
Phase I: Everolimus will be administered as follows: Dose level 1: 5 mg every other day, Dose level 2: 5 mg daily, Dose level 3: 10 mg daily Phase II: Everolimus will be administered at the dose determined in Phase .Everolimus will be continued for 12 months in the patients who achieve a CR or a Partial Response. Patients demonstrating a CR (by cystoscopy and cytology) or a Partial Response at their Cycle 12 cystoscopy will be observed with serial cystoscopies every 3 months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Everolimus
FDA approved

Find a Location

Closest Location:Memorial Sloan Kettering Cancer Center· New York, NY

Who is running the clinical trial?

New York UniversityOTHER
245 Previous Clinical Trials
228,564 Total Patients Enrolled
University of HawaiiOTHER
121 Previous Clinical Trials
55,158 Total Patients Enrolled
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,994 Previous Clinical Trials
602,644 Total Patients Enrolled
Novartis PharmaceuticalsIndustry Sponsor
2,946 Previous Clinical Trials
4,266,261 Total Patients Enrolled
Guido Dalbagni, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
2 Previous Clinical Trials
62 Total Patients Enrolled
~2 spots leftby Feb 2026