Second Line Sorafenib After Pazopanib in Patients With RCC (SOAP)

November 21, 2017 updated by: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Mi
      • Milan, Mi, Italy, 20156
        • Istituto Tumori

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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:

    • 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

Exclusion Criteria:

  • 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)
  • History of organ allograft
  • Patients with evidence or history of bleeding diathesis
  • Patients undergoing renal dialysis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: sorafenib
Sorafenib 400 mg bid
Drug: Sorafenib
Sorafenib 400 mg bid
Other Names:
  • Nexavar

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression Free Survival (months) of patients treated with sorafenib after progression to pazopanib
Time Frame: 24 months
24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety profile of sorafenib using Common Terminology Criteria for Adverse Events (CTCAE) criteria v.4.0 in patients previously treated with pazopanib
Time Frame: 24 months
24 months
Overall Survival (months) of patients treated with sorafenib after pazopanib progression
Time Frame: 24 months
24 months
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.
Time Frame: 24 months
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Actual)

November 8, 2017

Study Completion (Actual)

November 8, 2017

Study Registration Dates

First Submitted

April 6, 2014

First Submitted That Met QC Criteria

April 22, 2014

First Posted (Estimate)

April 24, 2014

Study Record Updates

Last Update Posted (Actual)

November 22, 2017

Last Update Submitted That Met QC Criteria

November 21, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GP2
  • Istituto Tumori Milano (Other Identifier: Ethical board)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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