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

NCT02479490 | Terminated Phase 2

• 1 other identifier: IRST189.04
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 4

Brief Summary

This is a multicenter prospective study that includes all patients with metastatic Renal Cell Cancer (RCC) pre- treated with VEGFR TKI in eight Italian cancer centers. 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.

Conditions

Metastatic Renal Cancer

Keywords

metastatic renal cancer; failure of VEGFR_TKI; prednisone; everolimus

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 + Everolimus DRUG

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years old
• Patients with histopathologically confirmed diagnosis of renal cell carcinoma
• Patients with renal cell carcinoma who failed at least one VEGFR TKI
• Patients with adequate bone marrow function defined as ANC ≥ 1.5 x 109/L, Platelets ≥ 80 x 109/L, Hb \>9 g/dL
• Patients with adequate liver function defined as serum bilirubin ≤ 1.5 x ULN, ALT and AST ≤ 2.5x ULN. Patients with known liver metastases who have an AST and ALT ≤ 5x ULN
• Patients with adequate renal function defined as serum creatinine ≤ 1.5 x ULN
• Patients who give a written informed consent obtained according to local guidelines

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

Sponsors & Collaborators

• Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS: lead

Study Sites (4)

U.O Oncologia Medica, IRST IRCCS

Meldola, FC, 47014, Italy

Location

Oncologia Medica, PO Faenza, AUSL della Romagna

Faenza, RA, 48121, Italy

Location

Oncologia Medica, PO RAVENNA, AUSL della Romagna

Ravenna, RA, 48121, Italy

Location

Oncologia Medica, PO Rimini-Cattolica, AUSL della Romagna

Rimini, 47923, Italy

Location

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: 28546463 DERIVED

MeSH Terms

Conditions

Kidney Neoplasms

Interventions

Prednisone; Everolimus

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sirolimus; Macrolides; Lactones; Organic Chemicals

Study Officials

• Ugo De Giorgi, MD

  IRST IRCCS, Meldola

  PRINCIPAL INVESTIGATOR

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
• Primary Completion: May 5, 2017
• Study Completion: September 1, 2017
• Last Updated: January 16, 2018

Record last verified: 2018-01

Locations

IT (4)