Neoplasms

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Carcinoma

Carcinoma, Transitional Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Transitional Cell Carcinoma

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Everolimus

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Everolimus (Afinitor®)

A study to determine the efficacy of Everolimus(Afinitor®) as third line therapy in patients with transitional cell carcinoma of the urothelium which failed or progressed after two lines of chemotherapy

The Efficacy of RAD 001 as Second Line Therapy in Patients With Transitional Cell Carcinoma TCC of the Urothelium

A Multicentre Phase III Trial to Determine the Efficacy of RAD 001 (Everolimus, Afinitor) as Second Line Therapy in Patients With Transitional Cell Carcinoma TCC of the Urothelium Which Failed or Progressed After First Line Chemotherapy

If a patient has not had an event, Progression-free survival is censored at the date of last adequate tumor assessment.

Hopital Foch

Symptoms and General Pathology

Carcinoma, Neuroendocrine

Neuroendocrine Tumors

Disease Progression

Disease Attributes

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Adenocarcinoma

Neuroendocrine Tumor

Neuroepithelioma

Patients receive Everolimus orally, 10 mg/day.

The end of study will be performed when tumor progression has been observed for 28 patients. Patients who are still under treatment at that time may continue with chemotherapy at the discretion of the investigator, but will be excluded from the study.

Formulation: 10 mg/day Route: oral (tablet)

Marianne Pavel, Prof. Dr.

The study is designed as an open-label, prospective, single arm, multicenter study of everolimus in histologically confirmed, neuroendocrine carcinoma G3 /neuroendocrine tumor G3 after failure of first-line platin-based chemotherapy (open-label pilot study).

The aim of this study is to provide a second line therapy to patients with any type of platinum based first line chemotherapy, to gather data on disease control rate and progression free survival.

As more efficient drugs are urgently needed for the treatment of neuroendocrine tumors the investigator evaluated phosphorylated Mammalian target of rapamycin (mTOR) and effectors in a series of NEC G3 at the Charité Center. Everolimus showed antiproliferative effects in bronchial NET.

In a second approach the data of this study should be the basis to generate another study to further explore everolimus as maintenance therapy in NEC G3/ NET G3.

Safety and Tolerability of Everolimus as Second-line Treatment in Poorly Differentiated Neuroendocrine Carcinoma / Neuroendocrine Carcinoma G3 (WHO 2010) and Neuroendocrine Tumor G3 - an Investigator Initiated Phase II Study

Incidence of adverse events (AEs) overall and by severity, and serious adverse events (SAEs). Severity will be assessed using the National Cancer Institute-Common Toxicity Criteria (NCI-CTC) for Adverse Events, version 4.03 (CTCAEv4.03).

To evaluate tolerability and safety of everolimus in second-line treatment of poorly differentiated neuroendocrine carcinoma / neuroendocrine carcinoma G3 according to WHO 2010 and neuroendocrine tumors G3.

Progression free survival (PFS) as the length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse as per local radiology assessment using Response Evaluation Criteria in Solid Tumors (RECIST 1.1.)

Objective response rate defined as the rate of best overall response (CR+PR), determined by RECIST V 1.1.

Disease control rate defined as the rate of best overall response and stable disease (CR+PR+SD), determined by RECIST V 1.1.

Duration of response is defined as the time from onset of the first objective tumor response (CR/PR) to objective tumor progression or death from any cause.

OS is defined as the time from date of randomization to the date of death from any cause. If a patient is not known to have died at the date of analysis cut-off, the OS will be censored at the last date of contact.

Quality of life (HRQoL) will be evaluated using the European Organisation for Research and Treatment of Cancer (EORTC), to assess the quality of life of cancer patients questionnaire (QLQ-C30)

Percentage of patients showing normalization or a decrease of chromogranin A \& B

Time to progression (TTP) is the time from date of start of treatment to the date of event defined as the first documented progression due to underlying cancer.

Percentage of patients showing normalization or a decrease of neuron-specific enolase

Percentage of patients showing normalization or a decrease of progastrin releasing peptide.

To explore expression of mTOR pathway components in tumor tissue (archive) in correlation to tumor response

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
The Efficacy of RAD 001 as Second Line Therapy in Patients With Transitional Cell Carcinoma TCC of the Urothelium	NCT01801137	Urothelial Canc...	Everolimus (Afi...	18 Years -	Hopital Foch
Safety and Tolerability of Everolimus as Second-line Treatment in Poorly Differentiated Neuroendocrine Carcinoma / Neuroendocrine Carcinoma G3 (WHO 2010) and Neuroendocrine Tumor G3 - an Investigator Initiated Phase II Study	NCT02113800	Poorly Differen... Neuroendocrine ... Neuroendocrine ... Neuroendocrine ... Neuroendocrine ...	Everolimus (Afi...	18 Years -	AIO-Studien-gGmbH

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