Neoplasms

All Conditions

Rare Diseases

Carcinoma

Carcinoma, Transitional Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Transitional Cell Carcinoma

Anti-Infective Agents

Antineoplastic Agents

All Drugs and Chemicals

Sirolimus

Temsirolimus

MTOR Inhibitors

Dactolisib

Protein Kinase Inhibitors

Enzyme Inhibitors

Immunosuppressive Agents

Immunologic Factors

* Group 1: patients without PI3K pathway activation; no loss of PTEN and no activating PIK3CA mutation.
* Group 2: patients with PI3K pathway activation as defined by PIK3CA mutation and/or PTEN loss

The investigational study drug used in this trial is BEZ235, supplied as 200 mg, 300 mg and 400 mg sachets. BEZ235 is administered continuously twice-daily; complete cycle is 28 days. Starting dose is 300mg PO bid. At cycle 1 day 15, based on a clinical assessment, dose is adjusted for the rest of the study:• If no adverse event (AE) or only mild AE (G1) : the dose will be increase to 400 mg bid• If AE = G2 : the patient will continue at 300 mg bid • If G3 AE or higher : BEZ235 will be interrupt until resolved to ≤ G1 then reduce dose to 200 mg bid

BEZ235

Jean-Pascal Machiels, MD, PhD

The mTOR (mammalian Target of Rapamycin) protein is the center of the mTOR pathway that plays an important role in cell growth, proliferation, survival and angiogenesis through sensing and integrating energetic signals from cellular environment. The mTOR protein is composed of two complex, mTOR complex 1 (mTOR C1) and mTOR complex 2 (mTOR C2).

In regards of mTOR pathway dysregulations observed in TCC development, there is a rational to test BEZ23 in advanced TCC. BEZ235 is a pan-class I PI3K inhibitor that, in addition, binds to the catalytic site of mTOR, inhibiting mTOR C1 and mTOR C2.

Study of BEZ235 as Monotherapy in Patients With Transitional Cell Carcinoma After Failure of Platinum Based Chemotherapy

A Single Arm, Multicenter, Phase II Study of BEZ235 as Monotherapy in Patients With Locally Advanced or Metastatic Transitional Cell Carcinoma (TCC) After Failure of Platinum Based Chemotherapy.

o Control disease rate at 16 weeks, including complete responses, partial responses and stable diseases according to RECIST criteria.

The patient will have an appointment with the investigator on day 15 of cycle 1 and every day 1 of each cycle.

Novartis

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Urinary Bladder Neoplasms

Carcinoma in Situ

Non-Muscle Invasive Bladder Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

During the induction phase, participants will receive enfortumab vedotin once a week for 6 weeks. During the maintenance phase, participants will receive enfortumab vedotin once a month for 9 doses.

Enfortumab vedotin

Seagen, Inc. Trial Information Support

Janet Trowbridge, MD

This study will test a drug called enfortumab vedotin in participants with a type of bladder cancer called non-muscle invasive bladder cancer (NMIBC).

This study will also evaluate what the side effects are and if the drug works to treat NMIBC. A side effect is anything a drug does to your body besides treating your disease.

In this study enfortumab vedotin will be put into the bladder using a catheter. A catheter is a thin tube that can be put into your bladder.

The study will be comprised of 2 parts. The first part (dose escalation) will find the highest dose of enfortumab vedotin that does not cause unacceptable side effects in participants. The second part (dose expansion) will use the dose found in the first part to test how well the drug works.

All participants will receive enfortumab vedotin. Treatment on the study will occur during the induction and maintenance phases, and participants will enter a follow-up period after completion of the maintenance phase.

A Study of Intravesical Enfortumab Vedotin For Treatment of Patients With Non-muscle Invasive Bladder Cancer (NMIBC)

An AE is any untoward medical occurrence in a subject or clinical investigational subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.

To be summarized using descriptive statistics.

AUC will be recorded from the PK blood samples collected.

Cmax will be recorded from the PK blood samples collected.

Tmax will be recorded from the PK blood samples collected.

T1/2 will be recorded from the PK blood samples collected.

Ctrough will be recorded from the PK blood samples collected.

Blood samples for ATA analysis will be collected.

CR rate is defined as the proportion of subjects achieving CR.

The time from first documented CR to the first evidence of recurrence, progression, or death due to any cause.

The proportion of subjects who subsequently undergo cystectomy.

The time from start of study treatment to the first evidence of progression or death due to any cause.

The time from start of study treatment to cystectomy or death due to any cause.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of BEZ235 as Monotherapy in Patients With Transitional Cell Carcinoma After Failure of Platinum Based Chemotherapy	NCT01856101	Carcinoma Trans...	BEZ235	18 Years -	Cliniques universitaires Saint-Luc- Université Catholique de Louvain
A Study of Intravesical Enfortumab Vedotin For Treatment of Patients With Non-muscle Invasive Bladder Cancer (NMIBC)	NCT05014139	Urinary Bladder... Carcinoma in Si... Carcinoma Trans... Non-muscle Inva... NMIBC	Enfortumab vedo...	18 Years -	Astellas Pharma Inc
Study of BEZ235 as Monotherapy in Patients With Transitional Cell Carcinoma After Failure of Platinum Based Chemotherapy	NCT01856101	Carcinoma Trans...	BEZ235	18 Years -	Cliniques universitaires Saint-Luc- Université Catholique de Louvain
A Study of Intravesical Enfortumab Vedotin For Treatment of Patients With Non-muscle Invasive Bladder Cancer (NMIBC)	NCT05014139	Urinary Bladder... Carcinoma in Si... Carcinoma Trans... Non-muscle Inva... NMIBC	Enfortumab vedo...	18 Years -	Astellas Pharma Inc

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