Trials Sponsors Conditions Drugs Pricing

Conditions

Metastatic Renal Cancer

Keywords

metastatic renal cancerfailure of VEGFR_TKIprednisoneeverolimus

Outcome Measures

Primary Outcomes (1)

safety and tolerability evaluation (incidence of grade ≥ 2 stomatitis and non-infectious pneumonitis)
to evaluate the incidence of grade ≥ 2 stomatitis and non-infectious pneumonitis in RCC patients treated with prednisone 5 mg bid and everolimus 10 mg/day.
up to 36 months

Secondary Outcomes (3)

Overall response rate (ORR)
up to 36 months
Progression free survival (PFS)
up to 36 months
Overall survival (OS)
up to 36 months

Study Arms (1)

Prednisone + Everolimus

EXPERIMENTAL

Prednisone + Everolimus

Drug: Prednisone + Everolimus

Interventions

Prednisone + EverolimusDrug

Prednisone + Everolimus: Everolimus is formulated as tablets of 5-10 mg strength, blister-packed under aluminium foil in units of 10 tablets. Prednisone will be dispensed to patients at the dose of 5 mg twice daily (BID). Everolimus at dose of 10 mg (one 10 mg tablet or two 5 mg tablets). Both drugs will be self-administered orally, continuously from Day 1 (Visit 2) until progression of disease, unacceptable toxicity, death or discontinuation for any other reason. A treatment cycle consists of 28 days.

Also known as: prednisone, everolimus

Prednisone + Everolimus

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Grouped treatment entry
Prednisone + Everolimus
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry record

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Age ≥ 18 years old
Patients with histopathologically confirmed diagnosis of renal cell carcinoma

Sponsors & Collaborators

Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
Otherlead

Study Sites (4)

U.O Oncologia Medica, IRST IRCCS

Meldola, FC, 47014, Italy

Oncologia Medica, PO Faenza, AUSL della Romagna

Faenza, RA, 48121, Italy

Oncologia Medica, PO RAVENNA, AUSL della Romagna

Ravenna, RA, 48121, Italy

Oncologia Medica, PO Rimini-Cattolica, AUSL della Romagna

Rimini, 47923, Italy

Related Publications (1)

Lolli C, Galla V, Schepisi G, Barone D, Burgio SL, Maugeri A, Vertogen B, Amadori D, De Giorgi U. A Phase II Study of Everolimus Plus Oral Prednisone in Patients with Metastatic Renal Cell Cancer. Oncologist. 2017 Jul;22(7):784-e74. doi: 10.1634/theoncologist.2017-0154. Epub 2017 May 25.
PMID: 28546463DERIVED

MeSH Terms

Conditions

Kidney Neoplasms

Interventions

PrednisoneEverolimus

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Study Officials

Ugo De Giorgi, MD
IRST IRCCS, Meldola
PRINCIPAL INVESTIGATOR

Enrollment

8 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

June 19, 2015

First Posted

June 24, 2015

Study Start

September 22, 2015

Actual (reported)

Primary Completion

You may not qualify if:

CNS disease OR patients with presence or history of central nervous system (CNS) lymphoma
Patients receiving chronic, systemic treatment with corticosteroids or another immunosuppressive agent (except corticosteroids with a daily dosage equivalent to prednisone ≤ 20 mg for adrenal insufficiency). However, patients receiving corticosteroids must be on a stable dose for ≥ 4 weeks prior to the first dose of everolimus. Topical or inhaled corticosteroids are permitted.
Patients with a known hypersensitivity to everolimus or other rapamycins (sirolimus, temsirolimus) or to its excipients
Patients with uncontrolled hyperlipidemia (≥ Grade 3 hyperlipidemia despite optimal supportive medical therapy)
Patients with an active, bleeding diathesis
Previous organ transplantation
Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as:
unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction within 6 months of start of study drug, serious uncontrolled cardiac arrhythmia or any other clinically significant cardiac disease
severely impaired lung function (spirometry and DLCO that is 50% of the normal predicted value and/or Oxygen saturation that is 88% or less at rest, in room air)
uncontrolled diabetes as defined by fasting serum glucose \>1.5 x ULN
any active (acute or chronic) or uncontrolled infections/disorders
non malignant medical illnesses that are uncontrolled or whose control may be jeopardized by the treatment with this study therapy
liver disease such as cirrhosis or severe hepatic impairment (Child-Pugh class C).
Note: a detailed assessment of Hepatitis B/C medical history and risk factors must be done at screening for all patients. HBV DNA and HCV RNA PCR testing are required at screening for all patients with a positive medical history based on risk factors and/or confirmation of prior HBV/HCV infection.
A known history of HIV seropositivity
+2 more criteria

PRednisone Plus EVerolimus in Patients With Metastatic Renal Cell Cancer After Failure of VEGFR -TKI

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (1)

Prednisone + Everolimus

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (4)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (1)

Prednisone + Everolimus

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (4)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations