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Metastatic Renal Cell CarcinomaPhase 2NCT01444807

Evaluate the Efficacy of Sorafenib in Renal Cell Carcinoma Patients After a Radical Resection of the Metastases

A Phase 2 study testing sorafenib in people with Metastatic Renal Cell Carcinoma, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 14 sites in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Evaluate the efficacy and tolerability of sorafenib in RCC patients underwent to metastasectomy Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Renal Cell Carcinoma
What is being tested?
sorafenib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
132 participants
Where
14 sitesItaly
Study dates
Dec 2011to Mar 2022
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years
  • Patients with cytological or histological diagnosis of Renal Cell Carcinoma (RCC)
  • Absence of residual lesions following surgical removal of metastatic disease. Assessment must be performed by CT-scan or MRI
  • Histologically proven disease free margins of resected surgical specimen
  • No more than three months from radical resection on metastases.
  • ECOG Performance Status of 0 or 2
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  • Life expectancy of at least 12 weeks.
  • Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening:
  • Hemoglobin > 9.0 g/dl
  • Absolute neutrophil count (ANC) >1,500/mm3
  • Platelet count 100,000/ml
  • Total bilirubin < 1.5 times the upper limit of normal
  • ALT and AST < 2.5 x upper limit of normal (< 5 x upper limit of normal for patients with liver involvement of their cancer)
  • Alkaline phosphatase 4 x ULN
  • PT-INR/PTT < 1.5 x upper limit of normal [Patients who are being therapeutically anticoagulated with an agent such as coumadin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists.] For patients on warfarin, close monitoring of at least weekly evaluations will be performed, until INR is stable based on a measurement at pre-dose, as defined by the local standard of care.
  • Serum creatinine < 1.5 x upper limit of normal
  • Amylase and lipase <1.5 X upper limit of normal
  • Signed informed consent must be obtained prior to any study specific procedures

Who cannot join

  • Prior systemic treatment for metastatic RCC. It is allowed an adjuvant or neoadjuvant therapy before or after nephrectomy if stopped at least 6 months before the resection of metastatic lesion/s.
  • History of cardiac disease: congestive heart failure >NYHA class 2; active CAD (MI more than 6 mo prior to study entry is allowed); cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted) or uncontrolled hypertension (>= 160 mmHg systolic and/or 90 mmHg diastolic).
  • History of HIV infection or chronic hepatitis B or C
  • Active clinically serious infections (> grade 2 NCI-CTC version 3.0)
  • Symptomatic metastatic brain or meningeal tumors unless the patient is > 6 months from definitive therapy, has a negative imaging study within 4 weeks of study entry and is clinically stable with respect to the tumor at the time of study entry. Also the patient must not be undergoing acute steroid therapy or taper (chronic steroid therapy is acceptable provided that the dose is stable for one month prior to and following screening radiographic studies)
  • Patients with seizure disorder requiring medication (such as steroids or anti-epileptics)
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  • History of organ allograft
  • Patients with evidence or history of bleeding diathesis
  • Patients undergoing renal dialysis
  • History of other disease, metabolic dysfunction, physical examination finding or clinical laboratory finding giving reasonable suspicion of a disease condition that contraindicates use of an investigational drug or patient at high risk from treatment complications
  • Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis \& T1) or any cancer curatively treated > 3 years prior to study entry.
  • Anticancer chemotherapy or immunotherapy during the study or within 4 weeks of study entry.
  • Radiotherapy during study or within 3 weeks of start of study drug.
  • Major surgery within 4 weeks of start of study
  • Autologous bone marrow transplant or stem cell rescue within 4 months of study
  • Use of biologic response modifiers, such as G-CSF, within 3 week of study entry. (G-CSF and other hematopoietic growth factors may be used in the management of acute toxicity such as febrile neutropenia when clinically indicated or at the discretion of the investigator, however they may not be substituted for a required dose reduction.) (Patients taking chronic erythropoietin are permitted provided no dose adjustment is undertaken within 2 months prior to the study or during the study)
  • Investigational drug therapy outside of this trial during or within 4 weeks of study entry
  • Prior exposure to the study drug.
  • Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment. Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial and two weeks after the completion of trial.
  • Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
  • Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study
  • Patients unable to swallow oral medications

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

Italy14 sites

  • Cinzia Ortega

    Alba

  • Alessandra Bearz

    Aviano

  • Alfredo Berruti

    Brescia

  • Saverio Cinieri

    Brindisi

  • Francesco Atzori

    Cagliari

  • Rodolfo Passalaqua

    Cremona

  • Francesco Di Costanzo

    Florence

  • Vincenzo Emanuele Chiuri

    Lecce

  • Istituto Tumori Milano

    Milan, Mi, 20156

  • Alessandra Mosca

    Novara

  • Vittorio Gebbia

    Palermo

  • Enrico Cortesi

    Roma

  • Francesco Cognetti

    Roma

  • Franco Morelli

    San Giovanni Rotondo

Other trials in Italy

About this study

Official title: A Randomized, Open Label, Multicenter Phase 2 Study, to Evaluate the Efficacy of Sorafenib in Patients With Advanced Renal Cell Carcinoma (RCC) After a Radical Resection of the Metastases

Evaluate the efficacy and tolerability of sorafenib in RCC patients underwent to metastasectomy

Read the detailed description

Advanced RCC presents poor prognosis, because its pathogenesis is not clearly understood. However, up-regulation of the Ras pathway is thought to play a role.

VEGF expression could represent independent prognostic factors for survival possibly linking expression of this protein with clinical outcome.

Sorafenib is a potent inhibitor of both Raf-kinase and VEGF R2 signalling The anti-tumoral activity of Sorafenib was clearly demonstrated in phase III trial regarding advanced pretreated RCC.

Surgical removal of metastatic disease could potentially increase the disease control rate.

Particularly in patients with a disease free interval post nephrectomy of at least 1 year, with one small metastatic lesion, metastasectomy could represents an important therapeutic approach.

After a radical resection of the metastatic disease is unclear if an anti-tumoral systemic therapy may increase patient survival.

In summary, both the preclinical and clinical data support further evaluation of Sorafenib in RCC patients.

Being tested
sorafenib
Keywords
sorafenib, metastatic renal cell carcinoma, metastasectomy
Medical subject headings
Carcinoma, Renal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • sorafenibDrug

    Also called Nexavar (Bayer Health Care - Leverkusen - Germany)

    sorafenib 400 mg bid

Study groups in NCT01444807
Study groupRoleWhat they receive
SorafenibExperimentalActive Arm
Receives: Drug: sorafenib
Best Supportive CareNo interventionComparator

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recurrence Free Survival

    Efficacy of Sorafenib compared with BSC, in RCC patients that have undergone radical resection of recurrent metastatic disease, after prior nephrectomy. The primary efficacy endpoint is Recurrence Free Survival (RFS),

    Measured: December 2011 - December 2014 (3 years)

Secondary outcomes (3)

  1. Overall Survival

    Measured: December 2011 - December 2014 (3 years)

  2. Safety Profile

    Physical examination, vital signs, Red blood count: haemoglobin, hematocrit, platelet count, white blood cell count. WBC should include differential neutrophil, lymphocyte, monocyte, basophil and eosinophil counts. Electrolyte panel: sodium, potassium, chloride and corrected calcium.Chemistry panel: AST, ALT, bilirubin, alkaline phosphatase, uric acid, total protein, albumin, calcium, lipase, amylase, phosphate, LDH, glucose, creatinine,BUN, and bicarbonate. Coagulation panel: PT, PT-INR, PTT. Urinalysis, Adverse event

    Measured: December 2011 - December 2014 (3 years)

  3. Vascular endothelial growth factors (VEGF) levels in BSC and Sorafenib arm.

    Measured: December 2011 - December 2014 (3 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Oct 2011 (estimated)
  2. Study startDec 2011
  3. Primary completionMar 2017
  4. Study completionMar 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
132 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01444807
Sponsor's protocol ID
GP1
Status last verified
Sep 2021
First submitted
8 Sep 2011
Last updated
17 Sep 2021
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes

Publications

  • Ljungberg B. The role of metastasectomy in renal cell carcinoma in the era of targeted therapy. Curr Urol Rep. 2013 Feb;14(1):19-25. doi: 10.1007/s11934-012-0293-6.

    PubMed 23212738

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing sorafenib in people with Metastatic Renal Cell Carcinoma, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 14 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recurrence Free Survival (time frame: December 2011 - December 2014 (3 years)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01444807, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2021.

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