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Metastatic Renal Cell CarcinomaPhase 2SOAPNCT02122003

Second Line Sorafenib After Pazopanib in Patients With RCC

A Phase 2 study testing Sorafenib in people with Metastatic Renal Cell Carcinoma, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 1 site in Italy.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Retrospective studies showed Sorafenib's efficacy as second line treatment after a Tyrosine Kinase Inhibitor (TKI). Currently there is no standard of treatment in 2nd line for patients treated in first line with pazopanib for metastatic Renal Cell Carcinoma (mRCC). 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
16 participants
Where
1 siteItaly
Study dates
Sep 2016to 8 Nov 2017
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 histological diagnosis of Renal Cell Carcinoma (RCC)
  • Measurable disease
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • 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:
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  • Hemoglobin >= 10.0 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
  • Alkaline phosphatase ≤ 4 x upper limit of normal
  • prothrombin time-international normalized ratio /partial thromboplastin time ≤ 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 international normalized ratio is stable based on a measurement at pre-dose, as defined by the local standard of care.
  • Prognosis according to Heng: good or intermediate
  • Previous treatment with pazopanib
  • 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.
  • Signed informed consent must be obtained prior to any study specific procedures

Who cannot join

  • First line treatment for metastatic RCC other than pazopanib.
  • History of cardiac disease: congestive heart failure >New York Heart Association 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
  • Active clinically serious infections (> grade 2 NCI-CTC version 3.0)
  • Brain or meningeal metastases
  • 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

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Istituto Tumori

    Milan, Mi, 20156

Other trials in Italy

About this study

Official title: Activity and Safety of Second Line SOrafenib After Pazopanib in Patients With Metastatic Renal Cell Carcinoma (SOAP Study)

  • Retrospective studies showed Sorafenib's efficacy as second line treatment after a Tyrosine Kinase Inhibitor (TKI).
  • Currently there is no standard of treatment in 2nd line for patients treated in first line with pazopanib for metastatic Renal Cell Carcinoma (mRCC).
  • With this trial we evaluate the efficacy of sorafenib as second line of treatment in patients treated with pazopanib for mRCC.
Read the detailed description
  • Retrospective studies showed Sorafenib's efficacy as second line treatment after a TKI: AXIS study showed sorafenib activity, in terms of Overall Response Rate (ORR), and the absence statistically significant difference in Overall Survival (OS) between the 2 arms, although there is a significant OS increase of 1.4 months in the Axitinib arm. The INTORSECT study (temsirolimus vs sorafenib in 2nd line after sunitinib) didn't demonstrate statistically significant difference for Progression Free Survival (PFS), but it showed an OS increase in patients treated with sorafenib.
  • The COMPARZ study demonstrated the non-inferiority of pazopanib vs sunitinib in 1st line of treatment for mRCC.
  • Currently there is no standard of treatment in 2nd line for patients treated in first line with pazopanib for mRCC.
  • Primary objective:to evaluate the efficacy of sorafenib (PFS) as second line of treatment in patients treated with pazopanib for mRCC.
  • Secondary objectives: To evaluate the safety of sorafenib in patients previously treated with pazopanib. To evaluate the Overall Survival. To evaluate the Quality of Life through specific questionnaires (FKSI-19; European Organization for Research and Treatment of Cancer quality of life questionnaire -C30).To assess the predictive role for PFS and OS of arterial blood pressure increase from baseline to week 4 and 8 after start of treatment with sorafenib. To assess the predictive role for PFS and OS of hand-foot syndrome before week 4 and 8 after start of treatment with sorafenib.
Being tested
Sorafenib
Keywords
sorafenib, pazopanib, cross-resistance, TKI, mRCC
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

    Sorafenib 400 mg bid

Study groups in NCT02122003
Study groupRoleWhat they receive
sorafenibExperimentalSorafenib 400 mg bid
Receives: Drug: Sorafenib

What is being measured

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

  1. Progression Free Survival (months) of patients treated with sorafenib after progression to pazopanib

    Measured: 24 months

Secondary outcomes (3)

  1. Safety profile of sorafenib using Common Terminology Criteria for Adverse Events (CTCAE) criteria v.4.0 in patients previously treated with pazopanib

    Measured: 24 months

  2. Overall Survival (months) of patients treated with sorafenib after pazopanib progression

    Measured: 24 months

  3. Quality of Life of patients treated with sorafenib after pazopanib progression using the specific questionnaires FKSI-19 and European Organization for Research and Treatment of Cancer quality of life questionnaire -C30.

    Measured: 24 months

Timeline

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

  1. First posted24 Apr 2014 (estimated)
  2. Study startSep 2016
  3. Primary completion8 Nov 2017
  4. Study completion8 Nov 2017

Why it stopped: availability of new and more promising therapeutic agents than expected in the experimentation in question

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02122003
Sponsor's protocol ID
GP2
Other IDs
Istituto Tumori Milano
Acronym
SOAP
Status last verified
Nov 2017
First submitted
6 Apr 2014
Last updated
22 Nov 2017
Results posted
No
Data monitoring committee
No

Publications

  • Iacovelli R, Verzoni E, Grassi P, Farcomeni A, de Braud F, Procopio G. Rationale and protocol of SOAP: a phase II study to evaluate the efficacy of sorafenib as second-line treatment after pazopanib in patients with advanced renal cell carcinoma. Tumori. 2014 Nov-Dec;100(6):e282-5. doi: 10.1700/1778.19296.

    PubMed 25688511

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 1 site 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 17 inclusion and 9 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: stopped early, as of the sponsor's last update on 22 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

The study was stopped early (reason given: availability of new and more promising therapeutic agents than expected in the experimentation in question). 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?

Progression Free Survival (months) of patients treated with sorafenib after progression to pazopanib (time frame: 24 months). 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 NCT02122003, 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 22 Nov 2017.

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